9 Regulatory Strategy Jobs

Walk In Drive for API Regulatory Affairs Dept (RA) @ R&D Center Work/Interview Location :- MSN R&D Center, Pashamylaram, Isnapur, Telangana Interview Date:- 05-07-2025 @Saturday Interview Time :- 9AM TO 2PM Venue Details : MSN Laboratories Pvt. Ltd., MSN R&D center, Pashamylaram, Isnapur, Patancheru, Sangareddy Contact :- 9154811048 Regulatory Affairs Specialist to join our API Division. This role is critical to ensuring compliance with regulatory requirements for our active pharmaceutical ingredients (APIs). The ideal candidate should have 1-7 years of regulatory affairs experience in the pharmaceutical industry. Key Responsibilities: Regulatory Submissions: Prepare, submit, and manage regulatory filings for API products, including new drug applications, amendments, and variations, while ensuring compliance with relevant guidelines and regulations. Documentation Management: Maintain, review, and update regulatory documentation, including drug master files (DMFs) and technical files, to support product registrations and renewals. Compliance Assurance: Stay up-to-date with regulatory changes, assess the impact on products, and provide recommendations for maintaining compliance. Communication: Interact with regulatory authorities, addressing inquiries, requests, and managing inspections and audits as required. Cross-functional Collaboration: Work closely with internal teams, including R&D, quality assurance, and production, to provide regulatory guidance and support for API-related activities. Quality Standards: Ensure that API products meet quality and safety standards in alignment with Good Manufacturing Practices (GMP) and other relevant quality regulations. Regulatory Strategy: Contribute to the development of regulatory strategies for product development and lifecycle management. Position : Executive Qualification : M.sc Work Location : MSN R&D Center, Pashamylaram. Department : API Regulatory Affairs Dept - ( API RA ) Experience : 1 to 7 Years Job Location : MSN Laboratories Pvt.Ltd., MSN R&D center, Pashamylaram, Isnapur, Patancheru,Sangareddy Interested Candidates can share there CVs to dinesh.baratam@msnlabs.com

Working knowledge of relevant global medical device regulations, requirements, and standards, such as ISO 13485, 21 CFR Parts 803, 806, and 820, ISO 14971, the European Medical Device Directive (93/42/EEC), and EU MDR (2017/745). Provide Quality and Regulatory Affairs input to the product development team and manage all QA & RA responsibilities throughout product development, design changes, and post-market surveillance processes. Establish and analyze key performance indicators to evaluate and continuously improve the Quality Management System (QMS). Possess broad experience and apply professional concepts and company objectives to resolve complex issues in creative and effective ways. Provide regulatory guidance and support to internal teams and stakeholders, including communicating regulatory changes, conducting training on quality and regulatory requirements, and fostering a culture of compliance within the organization. Experience interacting with the FDA and other regulatory authorities. Excellent analytical skills and the ability to synthesize trending data into meaningful information for the organization.

Key Result Areas/outputs Activities . Ensure that all licensing for assigned products is complete in accordance with relevant norms Monitor status of product licenses Manage changes in product licenses and coordinate with other changes, planned and in progress Maintain complete documentation records Communicate changes to licenses status promptly Develop and implement action regulatory plans for allocated products to achieve requisite approvals rapidly and facilitate rapid launch Maintain detailed knowledge of critical aspects of products: commercial strategies, the content of the dossiers, regulatory intelligence, regulatory timelines and supply strategy Ensure that local regulatory strategies are consistent with global product strategies and local priorities Develop regulatory plan in conjunction with key stakeholders and ensure allocation of adequate resources and deliver plans on time Track status and take prompt corrective measures whenever necessary to ensure rapid approval and launch Provide Leadership and direction within project teams Strive to ensure high levels of performance and achievements. Take decisions and accountability for actions. Build commitment within the team. Enhance positive attitudes and mindset. Demonstrate confidence and conviction. Challenge the status quo for continuous improvement. Help build an open and trusting atmosphere Assist in Issues. Interact with relevant regulatory authorities on a regular basis to facilitate the process of obtaining necessary approvals/permissions Monitor and understand the impact of external changes in the regulatory and political environment that will impact on the assigned products Communicate the impact of changes to key stakeholders. Influence key external stakeholders, in line with codes of conduct, to improve regulatory outcomes Develop excellent relationships and partnerships with Regulatory Authorities Competitive Intelligence and Analysis Monitor the global pipelines of competing pharmaceutical companies Analyse gathered the information for its impact on AstraZeneca s proposed pipelines Provide a scenario with options and a risk-benefit analysis for AstraZeneca going forward

Key Result Areas/outputs Activities . Ensure that all licensing for assigned products is complete in accordance with relevant norms Monitor status of product licenses Manage changes in product licenses and coordinate with other changes, planned and in progress Maintain complete documentation records Communicate changes to licenses status promptly Develop and implement action regulatory plans for allocated products to achieve requisite approvals rapidly and facilitate rapid launch Maintain detailed knowledge of critical aspects of products: commercial strategies, the content of the dossiers, regulatory intelligence, regulatory timelines and supply strategy Ensure that local regulatory strategies are consistent with global product strategies and local priorities Develop regulatory plan in conjunction with key stakeholders and ensure allocation of adequate resources and deliver plans on time Track status and take prompt corrective measures whenever necessary to ensure rapid approval and launch Provide Leadership and direction within project teams Strive to ensure high levels of performance and achievements. Take decisions and accountability for actions. Build commitment within the team. Enhance positive attitudes and mindset. Demonstrate confidence and conviction. Challenge the status quo for continuous improvement. Help build an open and trusting atmosphere Assist in Issues. Interact with relevant regulatory authorities on a regular basis to facilitate the process of obtaining necessary approvals/permissions Monitor and understand the impact of external changes in the regulatory and political environment that will impact on the assigned products Communicate the impact of changes to key stakeholders. Influence key external stakeholders, in line with codes of conduct, to improve regulatory outcomes Develop excellent relationships and partnerships with Regulatory Authorities Competitive Intelligence and Analysis Monitor the global pipelines of competing pharmaceutical companies Analyse gathered the information for its impact on AstraZeneca s proposed pipelines Provide a scenario with options and a risk-benefit analysis for AstraZeneca going forward

Business: Piramal Pharma Solutions Department: CRA Travel: Moderate JOB OVERVIEW: Preparation of licenses application & filing them on governmental portals for approvals from Indian regulatory authorities required for manufacturing, marketing and export of products in domestic and overseas markets by PPL sites in India. KEY STAKEHOLDERS: INTERNAL: Manufacturing sites, R&D ,Program management, Supply Chain, Marketing, site regulatory KEY STAKEHOLDERS: EXTERNAL: Govt. authorities like State FDA, CDSCO, FSSAI, CBN, NCB, custom officials, Customers etc REPORTING STRUCTURE: (Reports To/ Direct Reports Y/N): Direct report to General Manager-RA ESSENTIAL QUALIFICATION: Graduate KEY ROLES/ RESPONSIBILITIES: KEY ROLES/RESPONSIBILITIES: Registration Application on various Government portals (CBN, Sugam, FSSAI & XLN India) for new user Ids creation. Follow up with State FDA Thane, CDSCO, FSSAI, NCB for grant of licenses Product Registration application in Form 41 on DCGI Sugam Portal. Written confirmation (WC) application on DCGI Sugam Portal for APIs. Preparation & Online Submission for Import License application in Form 10 Preparation & Online Submission for CBN permissions (Import Certificates & Quarterly return filling) Preparation & Online Submission of API, RLD Test License Applications (Form11 & Form CT 17). Preparation & Online Submission of CDSCO permission in Form CT-11, CT-14 & CT-15, Dual Use NOC & Export NOC Preparation & Online Submission of application on state FDA portals like Test Licenses (Form 29), wholesale license etc., Preparation & Online Submission of various CBN application (Import/ Export/Quota/Mfg. License). Quarterly return submission to CBN/NCB/State FDA Provide regulatory strategies and support all stakeholders w.r.t assessment of D&C Act Feedback on new guidance Review and assessment for selection of product for manufacturing at site as per the D&C act To create PR in SAP to process payment for various bills/Invoices received from consultants. KEY COMPETENCIES: written and spoken communications skills, cross functional collaboration, negotiation skills, meticulous planning and execution for timely receipt of approvals.

The RA CMC Senior Manager is responsible for execution and/ or coordination of global regulatory CMC activities, including providing leadership, guidance, and insight to oversee the successful execution and implementation of the regulatory strategy for an assigned set of commercial products. The RA CMC Senior Manager is responsible for communicating the regulatory strategy, risks and issues to Regulatory and Operations senior management. The RA CMC Senior Manager coordinates communication, collaboration, and coordination with the site and regional CMC representatives within the department to develop and execute global regulatory activities. The RA CMC Senior Manager may have staff oversite. Key Activities Contributes to product teams and acts as Global RA-CMC lead or supervisor for one or more products. Provides strategic regulatory input and regulatory risk assessments for product teams; executes regulatory strategy with respect to preparation of submissions. Complies with critical RA CMC processes; identifies need for process and strategy changes to meet internal Amgen initiatives and changes in external regulatory policy and guidance. Reports needs for process changes to CMC systems and contributes to process improvements. Incorporates changes in external regulatory guidance into CMC strategy and guidance for product teams. Reports issues to RA CMC product team management. May manage and develop junior staff. Key Responsibilities Include: Oversees deliverables for CMC strategy and submissions for an assigned portfolio of products at varying stages of development. Works with external stakeholders including regulatory agencies and influential professional bodies, and seeks to influence regulatory policy globally. Identifies regulatory risks across products within the defined scope, communicates these risks, and ensures aligned plans for mitigation. Provides coaching, mentoring, and supports development of junior CMC Regulatory Affairs staff. Provide CMC regulatory strategy for assigned projects by defining minimal regulatory filing requirements, submission strategy, and regulatory risk assessments. Develop response strategy and respond to health authority questions. Liaise with other functions in development, operations and commercial to ensure alignment of global regulatory strategies, timing, execution and supply plans. Liaise with local regulatory teams to align on filing strategy. Monitor and, as necessary, provide data to be entered into tracking systems for department deliverables and ensure information is current. Maintain submission information according to the Regulatory Information Management (RIM) system. Follow established department regulatory processes to ensure cross-product alignment. May manage staff. Knowledge and Skills Regulatory CMC-specific regulatory knowledge & experience Staff management and development Education & Experience (Basic) Doctorate degree OR Master's degree and 3 years of directly related experience OR Bachelor's degree and 5 years of directly related experience OR Associate's degree and 10 years of directly related experience OR High school diploma / GED and 12 years of directly related experience Education & Experience (Preferred) Experience in manufacture, testing (QC/QA or clinical), or distribution Regulatory CMC experience

Regulatory Affairs Manager Devices What you will do Let's do this. Let's change the world. In this vital role you will support development and execution of regulatory strategies and filings for new and existing drug delivery devices and combination products, establishing sustainable processes, assuring informed relationships, and delivering strategic outcomes. Responsibilities: Support the development, communication, implementation, and maintenance of JAPAC regulatory strategic plans Lead and/or support JAPAC health agency engagements Lead and/or support JAPAC filing activities and associated health agency inquiries Support device design controls activities and documentation reviews Assess device-related standards and guidance for regulatory applicability; assist in establishing Amgen regulatory positions in the JAPAC region Perform change control regulatory assessments as it relates to JAPAC Develop and support implementation and maintenance of internal regulatory processes Perform device determination decisions for regulated items to be developed and/or used in JAPAC region Support supplier engagement teams and due diligence activities in the JAPAC region Review regulatory sections in development, quality, and supply agreements that impact JAPAC region Support regulatory compliance initiatives in the JAPAC region What we expect of you We are all different, yet we all use our unique contributions to serve patients. The Regulatory professional we seek is a leader with these qualifications. Basic Qualifications: Doctorate degree; or Master's degree and 2 years of pharma/biotech and/or medical device regulatory affairs experience; or Bachelor's degree and 4 years of pharma/biotech and/or medical device regulatory affairs experience Preferred Qualifications: Master's degree in regulatory affairs, engineering, or life sciences 6 or more years of experience in medical device regulatory affairs Experience in design controls, manufacturing, process development, quality assurance, quality control, or analytical development Experience in drug delivery device or diagnostics device regulatory submission process Regulatory CMC specific knowledge and experience Mature project management and organizational skills Strong and effective oral and written communication skills Experience in Veeva Vault platforms

Manager - International Regulatory Lead Role Name Manager International Regulatory Lead (IRL) Department Name International Regulatory Team, Global Regulatory Affairs Role GCF5A ABOUT AMGEN Amgen harnesses the best of biology and technology to fight the world's toughest diseases, and make people's lives easier, fuller and longer. We discover, develop, manufacture and deliver innovative medicines to help millions of patients. Amgen helped establish the biotechnology industry more than 40 years ago and remains on the cutting-edge of innovation, using technology and human genetic data to push beyond what's known today. ABOUT THE ROLE Role Description: The International Regulatory Lead (IRL) Manager will provide regulatory leadership & expertise for International countries for one or more Amgen products. This role involves collaboration with various functions and local regulatory teams to: optimize product development and regulatory approvals in International countries develop international regulatory strategy and provide regulatory support for in-country product registrations and life cycle management. Roles & Responsibilities: Advises Global teams on regulatory implications and requirements relevant to the global clinical development, Marketing Applications plans and objectives. Provides regulatory direction/expertise on the international regulatory mechanisms to optimize product development (e.g. expediting FIH studies, Orphan Drug, expedited regulatory designations, regulatory reliance mechanisms, compassionate use and pediatric plans). Under general supervision, plans regulatory submissions (e.g. clinical trial, marketing authorization applications and lifecycle management) for products within Amgen's portfolio. Under general supervision, contributes to the development of international regulatory strategy documents (regulatory product filing plan, strategies, risks associated with the potential Agency outcomes and contingency planning, estimate likelihood of success) and communicates to others, as appropriate. Provides and maintains clinical trial and/or marketing application documentation (excluding Chemistry, Manufacturing & Controls documentation). May author documents/redact such documents to support a regulatory filing. Directs development of and manages the international label submission strategy, leads the negotiation activities with cross-functional teams and is accountable for the label deviation requests and outcomes. Supports local regulatory teams in triaging queries from health authorities, and where appropriate, helps identify existing responses to same or similar questions, leveraging knowledge management. Participates as a member of the Global Regulatory Team (GRT), and various global clinical and labelling focused teams. Shares regulatory information and implications with the GRT and other global teams on an ongoing basis and provides advice on international considerations. Partners with peers to agree on product strategy including projected submission and approval time. Maintains regular communications with the local teams to ensure alignment on strategy and to share product development status. Builds effective relationships and communication paths across the global, regional and local elements of the global regulatory affairs function. Maintains an awareness of new and developing legislation, regulatory policy and technical regulatory guidance relating to Amgen products. Performs regulatory research to obtain relevant histories, precedence and other information relevant to regional product advancement. Basic Qualifications and Experience: Doctorate degree OR Master's degree and 3 years of relevant regional regulatory experience OR Bachelor's degree and 5 years of relevant regional regulatory experience OR Associate degree and 10 years of relevant regional regulatory experience OR High school diploma/GED and 12 years of relevant regional regulatory experience. Functional Skills: Must-Have Skills: Knowledge and experience in the international regulatory environment of clinical trial applications, non-clinical and/or clinical variations to marketing authorizations and product labelling relevant for biotechnology and/or oncology products Comprehensive knowledge of regulatory principles and understanding of regulatory activities, and how they impact other projects and/or processes General awareness of the registration procedures/challenges in International countries for Clinical Trial Applications, Marketing Applications and lifecycle management activities. Good-to-Have Skills: Ability to resolve conflicts and develop a course of action leading to a beneficial outcome Cultural awareness and sensitivity to achieve results across country, regional and international borders. Soft Skills: Strong communication skills, both oral and written Ability to understand and communicate scientific/clinical information Ability to work effectively with global, local and virtual teams High degree of initiative and self-motivation Planning and organizing abilities Ability to manage multiple priorities successfully Team-oriented, with a focus on achieving team goals Good negotiation and influencing skills.

Role: Project Corporate Affairs Support - Deputy Manager Department: Corporate Affairs Location: Umrongso, Dima Hasao, Assam Qualification: MBA / MSW / LLB Job description: Support in executing the organizational growth & transformation goals, and protect & promote the reputation of the business in the region Minimize expenditure through effectively managing the departmental budget whilst consistently identifying and initiating cost saving initiatives Liaise with relevant departments in the region to ensure mitigation of regulatory risks by way of identifying, assessing and creating mitigation plans for the same Responsibility to manage PR and represent DCBL in front of various external stakeholders as per business requirements Focus on building sustainable relations at political, bureaucratic & other administrative levels Liaise with govt departments and local bodies as for matters pertaining to laws and adherence to legal requirements Co-ordinate with various departments to timely file claims and speedy processing of the incentive proposals Stay updated on the key happenings, movements, and other developments in the region and share relevant information's to Regional Corporate Affairs Head