194 Regulatory Documentation Jobs

As a Regulatory Technical Writer at our company, you will be responsible for producing regulatory documentation and customer communications for our Midas product suite, focusing on healthcare. Your role will require exceptional attention to detail and proficiency in content tools to meet internal quality standards and external regulatory requirements. Your key responsibilities will include: - Taking content from regulatory documents and combining it with symplr content in FrameMaker and Acrobat - Transcribing and incorporating regulatory content into standardized document formats - Crafting new and improved product documentation to symplr standards - Using styles, variables, master pages, an...

(2 -4) Years of Work Experience in regulatory. WHO Collaborative countries having knowledge of Regulatory guideline viz ICH, EMEA , PIC.

We are looking for a skilled Pharmaceutical Regulatory Affairs Advisor to join our team at Metina Pharmaconsuting, with 6-10 years of experience in the pharmaceutical industry. Roles and Responsibility Develop and implement regulatory strategies for pharmaceutical products. Collaborate with cross-functional teams to ensure compliance with regulatory requirements. Prepare and review regulatory submissions such as clinical trial applications and marketing authorizations. Conduct risk assessments and provide recommendations on regulatory affairs matters. Stay updated with changing regulatory requirements and develop plans to address them. Provide guidance on regulatory documentation and record-...

As a highly skilled Senior Salesforce Business Analyst with expertise in Salesforce Service Cloud and Sales Cloud, your role will involve acting as the bridge between business needs and technology to drive scalable, high-quality Salesforce solutions. Your responsibilities will include: - Collaborating with stakeholders across Customer Service, QA, IT, and Operations to align platform capabilities with business goals - Conducting gap analyses, process mapping, and impact assessments for new features and integrations - Analysing and documenting business requirements related to case management, shipment tracking, and regulatory documentation across global pharma logistics operations - Translati...

As an Export Sales Manager for Basmati and Non-Basmati rice, your role will involve managing export documentation such as LC, BL, COO, Phyto, Invoice, Packing List, etc. You will be responsible for coordinating with CHA, shipping lines, and freight forwarders to ensure smooth shipment execution. Your duties will also include handling export order processing, negotiation, and dispatch planning. Regular communication with international clients for order updates and query resolution will be essential. Additionally, you will support export compliance, customs clearance, and regulatory documentation. You will also be tasked with preparing MIS reports related to export activities. Key Responsibili...

Who We Are Together, we're on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives. It's a mission that bonds our people across nearly 60 countries and a rich, diverse variety of nationalities and backgrounds. Working here means working with the world's leading manufacturer of generic medicines, and the proud producer of many of the products on the World Health Organization's Essential Medicines List. Today, at least 200 million people around the world take one of our medicines every single day. An amazing number, but we're always looking for new ways to continue making a difference, and new people to make a difference with. Th...

We are looking for a skilled Regulatory Consultant with 5-8 years of experience to join our team at Metina Pharmaconsuting, located in the Pharmaceutical & Life Sciences industry. Roles and Responsibility Develop and implement regulatory strategies to ensure compliance with pharmaceutical regulations. Prepare and review regulatory documents such as clinical trial applications and marketing authorizations. Collaborate with cross-functional teams to ensure timely submission of regulatory documents. Conduct risk assessments and provide recommendations on regulatory requirements. Stay updated with changes in regulatory requirements and advise on implications. Provide training and guidance to int...

The Candidate will be responsible to the Business Operations for Global as well as Developing New Business Opportunity by focusing on building and growing strong relationship both internally and externally. Devising effective Business Development Strategy for future research-based products with global Clients in Nutraceutical, Dietary & Natural/ Herbal Supplements for all categories. KEY DELIVERABLES: Strategic and Operational Excellence Identifying opportunities to build, develop and strengthen relationships with global clients to grow and sustain the business by strategizing optimum customer selection and management, team expansion and nurturing a healthy cross functional team culture. Ide...

SUMMARY Required qualifications (education) Bachelor’s (minimum) in Mathematical Finance, Financial Engineering, Applied Mathematics, Physics, or a related quantitative field Degree from a top tier university (e.g., Russell Group, Ivy League, equivalent) MSc/PhD desirable but not mandatory Required work experience 5 years of hands on model development for derivatives/structured products in at least one asset class 5 years of production level C++ programming Proficient in Python scripting for model calibration/automation Delivered quant libraries with minimal bugs and positive feedback from trading, structuring, and valuation control teams Experience with reserve methodology, model performanc...

As a highly skilled Senior Salesforce Business Analyst with expertise in Salesforce Service Cloud and Sales Cloud, you will play a crucial role in bridging business needs with technology to deliver scalable and high-quality Salesforce solutions. Your excellent communication and problem-solving skills will be instrumental in managing complex requirements in a fast-paced, Agile/Scrum environment. **Key Responsibilities:** - Collaborate with stakeholders from Customer Service, QA, IT, and Operations to align platform capabilities with business goals. - Conduct gap analyses, process mapping, and impact assessments for new features and integrations. - Analyze and document business requirements re...

Role & responsibilities To ensure completion of documentation as per requirement for receipt of all license and certificates. Gather relevant data from relevant departments and compile the licensing application in standard format for fresh/ renewal/ test licenses / COPP etc. Maintenance of drug licenses of all CNF locations and manufactures and follow up with them for renewal as and when required. Preparation of documents for tender. Issuing Brand NOCs to supply chain departments for getting license on P to P basis as per the requirement. Proactive, interactions with the concerned personnel's for follow up for FDA pending jobs (Baddi, Daman, LL Locations, TP etc). Maintain records of all lic...

Responsibilities: * Develop regulatory strategies & guidelines * Ensure compliance with ISO standards * Lead consulting services for clients * Prepare technical documents & reports * Manage regulatory submissions & approvals

As the Lead of the Mechanical team at our company, you will be responsible for designing and developing advanced medical diagnostic devices. Your role will involve driving innovation in mechanical systems while ensuring reliability, manufacturability, and compliance with medical device standards. You will be expected to deliver robust solutions that seamlessly integrate with optical, microfluidic, electronic, and software subsystems. **Key Responsibilities:** - Lead product design and development from concept to validation and transfer to manufacturing, ensuring technical and process integrity. - Provide technical leadership in developing mechanical subsystems that integrate seamlessly with ...

Dear Candidate, We are hiring for the Regulatory Affairs role-handling the below job responsibilities, Job Title: Regulatory Affairs Manager Company: Brinton Pharmaceuticals Ltd. Location: Kharadi, Pune Salary: Best in Industry Joining: Immediately Job Description: Regulatory Affairs Manager Position Overview: We are seeking an experienced and resourceful Regulatory Affairs Manager to lead efforts focused specifically on product approvals, price compliance, and regulatory risk mitigation in support of sales, pricing, and marketing. Key responsibilities include obtaining necessary approvals, ensuring price compliance, reviewing promotional materials, and addressing regulatory risks in domesti...

Roles and Responsibilities Responsible for preparation & compilation of the dossiers in CTD/eCTD/ACTD and other formats as required for submission to different regulatory authorities. Review the documents i.e. Specifications, Batch Records, STP, Stability Protocol, Dissolution protocols & DMF documents etc. Preparation of pharmaceutical/quality part (all forms) of registration dossiers & variations/amendments/annual reports as applicable documents in CTD and eCTD format. Preparation of query response for submitted applications received from various regulatory authorities. Responsible for review of change controls and checking for regulatory compliance for all documents. Exposure of Dossier c...

As a Regulatory Affairs Executive at our company, your role will involve preparing, reviewing, and submitting regulatory documents while ensuring compliance with national and international standards. You will be responsible for maintaining accurate records of communications, approvals, and submissions. Your key responsibilities will include: - Prepare, review, and maintain regulatory submissions and documentation. - Communicate with clients and regulatory authorities for updates and approvals. - Ensure compliance with all relevant regulations, standards, and guidelines. - Support internal teams in understanding and implementing regulatory requirements. - Stay informed about changes in regula...

As a Document Controller for the pipeline project in Navi Mumbai, your role will involve managing all project-related documentation to ensure effective document control practices are maintained across all phases of the project. Key Responsibilities: - Maintain and update the Document Management System (DMS) for the pipeline project. - Receive, log, and distribute incoming and outgoing documentation, drawings, and correspondence. - Ensure all documentation meets company/project quality standards and regulatory requirements. - Track revisions and ensure only the latest approved documents are circulated. - Coordinate with engineering, procurement, and construction teams to manage document workf...

Candidate should perform literature search Should have some basic understanding of patent and generic formulation development Characterization of marketed product wrt market requirements

As a Drug Regulatory Affairs Specialist at Medyur Pharmaceuticals Limited, you will be responsible for ensuring compliance with regulatory requirements for our products and driving successful product launches. You will collaborate with cross-functional teams to maintain regulatory compliance and facilitate smooth communication with regulatory bodies. Key Responsibilities: - Prepare and submit regulatory documentation such as dossiers for pre-market submissions to obtain necessary approvals. - Stay up to date on current regulatory requirements, guidelines, and industry trends in global markets. - Develop and maintain strong relationships with regulatory bodies to support approvals. - Review c...

SUMMARY Required qualifications (education) Bachelor’s (minimum) in Mathematical Finance, Financial Engineering, Applied Mathematics, Physics, or a related quantitative field Degree from a top tier university (e.g., Russell Group, Ivy League, equivalent) MSc/PhD desirable but not mandatory Required work experience 5 years of hands on model development for derivatives/structured products in at least one asset class 5 years of production level C++ programming Proficient in Python scripting for model calibration/automation Delivered quant libraries with minimal bugs and positive feedback from trading, structuring, and valuation control teams Experience with reserve methodology, model performanc...

Job Description: Company Secretary About GST Manager GST Manager is a leading financial and compliance solutions company specializing in GST, accounting, and business consulting. We are committed to simplifying complex financial processes and delivering accurate, compliant, and timely results for our clients. Role Overview We are seeking a qualified Company Secretary (CS) with at least 1 year of experience to handle statutory compliance, governance, and secretarial matters. The ideal candidate should have sound knowledge of corporate laws, MCA filings, and regulatory documentation. Key Responsibilities Ensure compliance with all statutory and regulatory requirements under the Companies Act a...

The Candidate will be responsible to the Business Operations for Global as well as Developing New Business Opportunity by focusing on building and growing strong relationship both internally and externally. Devising effective Business Development Strategy for future research-based products with global Clients in Nutraceutical, Dietary & Natural/ Herbal Supplements for all categories. KEY DELIVERABLES: Strategic and Operational Excellence Identifying opportunities to build, develop and strengthen relationships with global clients to grow and sustain the business by strategizing optimum customer selection and management, team expansion and nurturing a healthy cross functional team culture. Ide...

Senior Medical Writer Experience: 3 - 7 Years Exp Salary : Competitive Preferred Notice Period : Within 30 Days Opportunity Type: Onsite (Ahmedabad) Placement Type: Permanent (*Note: This is a requirement for one of Uplers' Clients) Must have skills required : CRO, writing scientific/regulatory/ clinical documents, MS Office suite Tatvacare (One of Uplers' Clients) is Looking for: Senior Medical Writer who is passionate about their work, eager to learn and grow, and who is committed to delivering exceptional results. If you are a team player, with a positive attitude and a desire to make a difference, then we want to hear from you. Role Overview Description Company Overview Tatvacare is a cu...

SUMMARY Required qualifications (education) Bachelor’s (minimum) in Mathematical Finance, Financial Engineering, Applied Mathematics, Physics, or a related quantitative field Degree from a top tier university (e.g., Russell Group, Ivy League, equivalent) MSc/PhD desirable but not mandatory Required work experience 5 years of hands on model development for derivatives/structured products in at least one asset class 5 years of production level C++ programming Proficient in Python scripting for model calibration/automation Delivered quant libraries with minimal bugs and positive feedback from trading, structuring, and valuation control teams Experience with reserve methodology, model performanc...

UNOTEX PHARMA LLP is an Indian pharmaceutical export company headquartered in Surat, Gujarat. We specialize in exporting high-quality branded and generic formulations across a wide range of therapeutic categories, including Oncology, Nephrology, Cardio-Diabetic, Gastrointestinal, Pain Management, Dermatology, Hormonal, Respiratory, Ophthalmic, Neurology, and Anti-Infective. With a strong presence in over 20 international markets, we are committed to providing reliable, affordable, and effective healthcare solutions. Our operations are built on trust, quality, and long-term partnerships, ensuring timely supply and regulatory compliance. As an International Business Specialist at UNOTEX PHARMA...