132 Regulatory Documentation Jobs

ABOUT THE ROLE The Regulatory Affairs Senior Associate role assists US Promotion Regulatory representatives and other cross-functional roles in the administration of regulatory strategies for department initiatives across all product brands. This role assists with preparing, tracking, reporting, and archiving US regulatory documentation, including preclearance and advisory comment promotional materials, and is responsible for all Ad/Promo regulated data management. This role performs the planning and tracking of all US promotional label changes and manages the system update of promotional labeling and Important Safety Information (ISI). This role is responsible for US digital labeling and tr...

JOB SUMMARY: Knowledgeable in all disciplines of ecotoxicology, including aquatic, plants, avian, mammals, and terrestrial. Conduct ecotoxicological risk assessments and provide expert guidance to internal colleagues on ecotoxicology issues, including responses to Regulatory decisions, Data Call In reviews and recommendations, and planning defense strategies around ecotoxicology concerns. Experience with interacting with regional Regulatory Agencies especially US-EPA and European Authorities. Familiar with global data requirements, including North America, Brazil, LATAM, and Europe. Contract ecotoxicology studies at external labs. Interpret study results and implications of results. Provide ...

Job Insights: Our client is seeking an ambitious and energetic Medical Writer for the authoring of aggregate safety reports to join their Safety team Responsibilities: Responsible for the entire life cycle of the document and accountable for maintaining quality and timeliness, and compliance to internal/client SOPs and regulations. Responsible for end-to-end authoring of complex deliverables - periodic aggregate reports, including PBRERs, DSURs, SUSAR, PADERs/PAERs, ACOs, RMPs, and ad-hoc regulatory and safety reports, send documents for review on a timely manner, liaise with subject specific stakeholders, set up review comments resolution meetings when needed, facilitate QC process, referen...

Working with Us Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible. Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a w...

Role & responsibilities You will lead the regulatory activities for all Convatec products including product registration (new, renewal and amendment), product promotional activities, labeling review activities, product registration and listing database. Location: Gurgaon Key duties and responsibilities Develop regulatory strategy and update the strategy based upon regulatory changes and business needs. Manage and execute regulatory compliance activities as required by the local regulations Compile, prepare, review and submit regulatory submissions to the local health authorities as well as to identify issues early in the submission preparation process that could impact product launch Monitor...

Preparation & compilation of Dossiers Knowledge of UK & EU Market, CTD Review of Artwork. Registration of renewal of products Solve Queries & Timely compile materials for license renewals, updates and registration Review changes to existing products Education PG: M.Pharma in Pharmacy

Role Overview: You will be the Controlled Documentation Lead in the R&D Quality department at Amgen, responsible for managing end-to-end lifecycle of controlled documents to ensure compliance with regulatory standards and internal quality procedures. Your role will involve coordinating document workflows, conducting QC reviews, maintaining document templates, and supporting audits and inspections. Key Responsibilities: - Coordinate and manage document workflows (e.g., SOPs, templates) to meet project timelines and compliance standards. - Track documentation milestones and follow up with contributors to ensure deadlines are met. - Provide technical editing and proofreading support to maintain...

As a Senior Technical Officer - Phytochemist, you will be instrumental in designing innovative products and ensuring the scientific standardization of Ayurvedic formulations. Your key responsibilities will include: - Leveraging your Phytochemical Expertise by demonstrating in-depth knowledge of the chemical composition of medicinal plants, active compounds, and secondary metabolites, and utilizing chromatographic and spectroscopic techniques for compound identification and quantification. You will also identify synergistic interactions among plant constituents to optimize therapeutic efficacy. - Driving Product Development by formulating Ayurvedic products tailored to address lifestyle disea...

Job Description Summary Join GE HealthCare as a Lead Specialist in Regulatory Affairs and play a pivotal role in shaping the future of medical imaging. This global leadership position offers the opportunity to drive regulatory strategies and lead cross-functional teams to bring innovative X-ray imaging products to market. Be part of a dynamic environment where your expertise will directly impact patient care and healthcare outcomes worldwide. GE Healthcare is a leading global medical technology and digital solutions innovator. Our mission is to improve lives in the moments that matter. Unlock your ambition, turn ideas into world-changing realities, and join an organization where every voice ...

Ensure compliance with GMP, FDA, and other regulatory standards Conduct quality checks on raw materials, in-process materials, and finished products Ensure compliance with regulatory requirements for drug development, manufacturing, and marketing.

Description AWS Global Sales drives adoption of the AWS cloud worldwide, enabling customers of all sizes to innovate and expand in the cloud. Our team empowers every customer to grow by providing tailored service, and unmatched technology. We dive deep to understand each customer's unique challenges, then craft innovative solutions that accelerate their success. This customer-first approach is how we built the world's most adopted cloud. Join us and help us grow. Amazon Web Services (AWS) India is rapidly expanding its presence in Financial Services. AWS offers global public cloud offerings with a diversity of GRC/Compliance programs and attestations to enable our customer base. AWS India Pv...

Job Position: Cosmetics Regulatory Affairs Specialist Working Days: Monday to Friday Shift Time- 12 PM IST- 9 PM IST On-Site Role We are looking for a detail-oriented and knowledgeable Cosmetics Regulatory Affairs Specialist to join our team. The ideal candidate will have a strong understanding of regulatory policies, documentation, and compliance requirements related to cosmetics. This role will be responsible for ensuring that all products meet local and international regulatory standards. Key Responsibilities: • Prepare and submit regulatory documentation for cosmetic product approvals and registrations. • Ensure compliance with all relevant regulations, guidelines, and standards related ...

Role Overview: You will be responsible for conducting primary research and literature review on skincare, haircare, or cosmetic ingredients and technologies. Developing and testing prototypes, optimizing formulations, and conducting stability and compatibility testing will be key aspects of your role. Collaboration with cross-functional teams from ideation to launch, preparing product briefs and regulatory documentation, and analyzing consumer trends and competitor benchmarks will also be part of your responsibilities. Key Responsibilities: - Conduct primary research and literature review on skincare, haircare, or cosmetic ingredients and technologies. - Develop and test prototypes in-house ...

Formulation Experience Mandatory: Well aware of EU, Australia, Ukraine & UK market requirement Dossier Preparation in ACTD & CTD Format ICH guidelines Communication skills Documents Management Stakeholder Communication

Responsible for the day-to-day activities of Regulatory Correspondence Department Co-ordinate with regulators. Maintain updates of action take regarding various correspondence Keep track of various circulars / notifications/ correspondence Required Candidate profile 7+ Exp in Capital Market Exp in coordinating & communicating with regulators Prepare reports / MIS Arranging & drafting minutes of the meetings

Dossier Preparation & Compilation: Lead the preparation, review, and submission of regulatory dossiers in CTD, ACTD, and eCTD formats for global markets, ensuring adherence to country-specific regulations. Regulatory Strategy & Market Compliance: Develop and implement regulatory strategies for product approvals across ROW, LATAM, SEA, Africa, and Pacific regions. Bioequivalence Studies & Compliance: Coordinate with CROs to ensure compliance and timely approval of bioequivalence studies for international submissions. Product Lifecycle Management: Oversee regulatory activities throughout the product lifecycle including renewals, variations, and post-marketing compliance. Product Registration &...

Job Position: Cosmetics Regulatory Affairs Specialist Working Days: Monday to Friday Shift Time: 12 PM IST- 9 PM IST We are looking for a detail-oriented and knowledgeable Cosmetics Regulatory Affairs Specialist to join our team. The ideal candidate will have a strong understanding of regulatory policies, documentation, and compliance requirements related to cosmetics. This role will be responsible for ensuring that all products meet local and international regulatory standards. Key Responsibilities: ? Prepare and submit regulatory documentation for cosmetic product approvals and registrations. ? Ensure compliance with all relevant regulations, guidelines, and standards related to cosmetics....

As a Regulatory Affairs Executive, you will play a critical role in managing regulatory documentation and ensuring compliance with ISO guidelines within the manufacturing sector. Your attention to detail and strong knowledge of regulatory affairs will be essential for success in this role. Key Responsibilities: - Manage and maintain all regulatory documentation related to manufacturing operations. - Ensure compliance with applicable ISO guidelines, certifications, and standards. - Coordinate and participate in ISO audits (internal and external). - Prepare, review, and maintain SOPs and documentation for regulatory compliance. - Liaise with different departments to ensure quality and complian...

Company Description Adiuvo Diagnostics is a techno-social enterprise focused on developing state-of-the-art platform technologies in optoelectronics. Our mission is to aid early disease detection and to enable advanced healthcare diagnostics in low-resource settings. We strive to bring cutting-edge diagnostic technologies to the places they are needed most. Job Description We are seeking a highly driven Principal Engineer & Head of R&D (Hardware & Optics) to lead the development of next-generation medical diagnostic devices. This role requires a unique blend of hands-on technical expertise, cross-disciplinary knowledge, and leadership skills. The ideal candidate will not only design and exec...

Job Title: Regulatory Affairs Specialist Med/Pharma (Female) Location: Remote Position Overview: We are seeking an experienced Regulatory Affairs professional with expertise in both pharmaceutical and medical device regulatory compliance. The role involves preparing, reviewing, and submitting regulatory documentation to global health authorities, ensuring compliance with applicable regulations (FDA, EMA, CDSCO, MHRA, ISO 13485, ICH guidelines). The ideal candidate will have a strong background in regulatory submissions, product lifecycle management, and cross-functional collaboration to support product development, registration, and commercialization. Key Responsibilities: Prepared, reviewed...

You are a dedicated Quality Assurance Officer joining a team in Halol. Your experience in the chemical or pharmaceutical industry will be crucial as you ensure compliance with quality standards, implement QA protocols, and maintain regulatory documentation. Your role will involve overseeing quality assurance processes in production to uphold high standards, ensuring compliance with industry regulations and company policies, and updating quality documentation, reports, and audits. Collaborating with cross-functional teams to enhance quality standards will be essential, along with assisting in audits and regulatory inspections. You will be responsible for documenting and reporting product or s...

You will be joining our SCM II - Technical Publication team as a skilled Technical Writer. Your role will involve working on regulatory documentation with a focus on federal aviation/authority guidelines. It is essential for you to have experience in creating technical content that is clear, concise, and compliant with product, process, and UCS guidelines. Your responsibilities will include managing Configuration Management Processing tasks such as verifying and validating code changes for each version release, ensuring department practices align with procedures, analyzing software documentation for compliance, and addressing inquiries regarding software shipments and distribution requiremen...

We are looking for a highly experienced Senior Biostatistician Consultant with over 8 years of experience in statistical modeling, platform development, and advanced analytical solutions. This role requires in-depth knowledge of biostatistics, statistical process control, and extensive experience in developing and deploying R Shiny-based analytical platforms. As a Senior Biostatistician Consultant, you will play a crucial role in building scalable statistical platforms that facilitate data-driven decision-making through advanced analytics. Your responsibilities will involve guiding scientific data interpretation, supporting both regulated and non-regulated environments, and delivering top-no...

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...

The Regulatory Affairs Executive is responsible for ensuring compliance with regulatory requirements for pharmaceutical products. Your primary role will involve preparing and submitting regulatory documentation, coordinating with internal teams, and staying informed about industry regulations. You will play a crucial part in ensuring product approvals and renewals, liaising with regulatory authorities, and reviewing product labeling to maintain regulatory compliance. Additionally, you will collaborate with cross-functional teams for data collection, maintain regulatory files, monitor regulatory guideline changes, and assist in audits and inspections by regulatory agencies. To qualify for thi...