170 Regulatory Documentation Jobs - Page 2

Role Overview: You will be responsible for planning and managing medical writing for Regulatory and Pharmacovigilance Verticals in compliance with applicable regulatory guidelines. Your main duties will include providing high-quality medical and scientific writing, offering technical consultation, demonstrating subject matter expertise, managing medical writing projects, collaborating with internal and external clients, and ensuring document output compliance with client specifications. Key Responsibilities: - Provide high-quality medical and scientific writing from planning and coordination of literature search through delivery of final drafts to internal and external clients. - Offer techn...

Role Overview: You will be responsible for preparing consistent and high-quality technical documents related to Pharmaceutical Research and Development for Formulation at Teva. Your role will involve executing all functions in accordance with current FDA regulations, ICH guidelines, USP methodologies, cGMPs, and SOPs. Maintaining open communication with R&D members to ensure timely delivery of high-quality documents independently with minimal supervision will be a key aspect of your responsibilities. Key Responsibilities: - Prepare documents and facilitate documentation management in R&D while ensuring correctness, completeness, and clarity following established guidelines. - Prepare documen...

A policy & regulatory leadership role in a evolving renewable energy sector Be part of an organization shaping India's clean energy transition. Job Description The ideal candidate will lead policy research, regulatory analysis, and advocacy efforts in alignment with the company's renewable business strategy. The role includes tracking central and state-level regulations, managing regulatory filings and compliance, and representing the organization in key forums, consultations, and industry associations. The Successful Applicant 10-15 years of experience in policy, regulatory affairs, or energy law within the renewable energy or power utility sector. Strong knowledge of open access, FDRE, RTC...

Lead the entire liaisoning function for a major Indian carbon company. High-impact role ensuring strategic regulatory compliance in Bangalore . Job Description Develop and implement a comprehensive Liaisoning strategy aligned with corporate goals and regulatory needs. Serve as the senior point of contact for all government and statutory authorities. Oversee the acquisition and timely renewal of all statutory clearances (CTE/CTO, fire NOCs, hazardous waste). Ensure zero non-compliance through timely internal audits and preparation for external inspections. Build and maintain strong relationships with local government, municipal bodies, and community leaders. Collaborate with internal departme...

Role: Regulatory Affairs Associate I (Regulatory Operation- Regulatory Data Analytics) Primary purpose of the role: The role of GRO Regulatory Data Analytics is to: Manage Teva's data in accordance with requirements for xEVPMD in order to maintain Teva's Article 57 compliance Provide a Central Data Service for the creation and maintenance of GRA product registration data in line with the global needs of Teva Global Regulatory Affairs. Provide SME services for data management in current and future regulatory data systems The primary purpose of this position is to execute the operations and services applicable to the GRO Regulatory Data Analytics role in line with business goals and objectives...

Company Description Dyaz Innovate is a software company with its flagship product, DyazRIMS, which supports the entire regulatory compliance process. The company is committed to enhancing regulatory processes for clients globally and promotes an engaging and supportive work environment. Role Description This is a full-time on-site role for a Senior Regulatory Affairs Specialist, located in Hyderabad . The Senior Regulatory Affairs Specialist will be responsible for managing regulatory documentation, ensuring regulatory compliance, overseeing regulatory submissions, and staying updated with regulatory requirements. This role involves coordinating with various departments to ensure all regulat...

Please share your resume at anita.searchrx@gmail.com Role & responsibilities Preparation, compilation, and review of Drug Master Files (DMFs) and Active Substance Master Files (ASMFs) for submission to various regulatory authorities (USFDA, EDQM, TGA, PMDA, etc.). Handle query responses from global regulatory agencies and ensure timely and accurate replies. Coordinate with R&D, Quality Assurance, Quality Control, and Production teams for regulatory data collation. Review of technical documents such as specifications, analytical methods, process descriptions, and stability data. Support in the preparation of Annual Product Reviews and Post-Approval Changes . Maintain and update regulatory dat...

As a highly motivated individual with a passion for communication and a desire to make a difference in the healthcare industry, you are encouraged to apply for this exciting opportunity. Your impact will involve utilizing your minimum 2 years of experience in medical writing or equivalent experience in the life sciences domain. Specifically, you will be responsible for the End-to-End authoring of periodic aggregate reports, including PBRERs, DSURs, SUSAR, PADERs/PAERs, ACOs, RMPs, and ad-hoc regulatory and safety reports. Key Responsibilities: - End-to-End authoring of periodic aggregate reports such as PBRERs, DSURs, SUSAR, PADERs/PAERs, ACOs, RMPs, and ad-hoc regulatory and safety reports ...

As a Regulatory Affairs Associate at Vamsi Pharma Pvt. Ltd. (VPPL), your role involves handling regulatory documentation and submissions to regulatory authorities. You will be responsible for ensuring that all regulatory requirements and compliance standards are met. This includes monitoring and interpreting regulatory updates and changes to adapt processes accordingly. Your duties will also include ensuring product compliance with all relevant standards and regulations, as well as developing product artwork for new products based on specific requirements. Collaboration with cross-functional teams is essential to ensure regulatory compliance in product development. Key Responsibilities: - Ha...

Role & responsibilities Dossier and regulatory document preparation Regular discussion and interactions with customer's regulatory team to answer queries regarding documentations Visiting FDA office for follow ups on applications Preferred candidate profile Deep knowledge of regulatory frameworks in Southeast Asia (especially the ACTD structure), Africa, and Latin America, and ability to interpret country-specific requirements for dossier submissions. Proficiency in preparing, compiling, and presenting regulatory dossiers (including administrative, quality, nonclinical, and clinical sections) according to the ACTD and local formats. Strong documentation management, including version control,...

You will be joining the Formulation R&D team at Hetero Drugs as a Scientist II, focusing on the development of sterile injectable formulations, including aqueous, non-aqueous, lyophilized, and peptide-based oncology products. Your role will be crucial in advancing product development for regulated markets such as the US, Europe, and ROW. You will be responsible for comprehensive formulation design, process optimization, regulatory documentation, and coordination across departments. - Independently lead the development of sterile injectable products, including aqueous, non-aqueous, lyophilized, and peptide-based formulations. - Conduct formulation studies, process optimization, and scale-up a...

Position: Senior Regulatory Affairs Manager Global Cosmetics Compliance Department: Regulatory Affairs / Operations Reports to: COO (Integrator) & CEO Location: India, Noida- Sec- 63 Employment Type: Full-time Shift Time- 12 PM IST- 9 PM IST About CBAYEXPRESS / Herbishh: CBAYEXPRESS CORPORATION is a Canadian-based e-commerce company selling across Amazon (US, CA, MX, UK, EU, AU, SG, IN, UAE), Walmart, Shopify (Herbishh.com, BisonBody.com), eBay, and other marketplaces. Our flagship brand Herbishh is a leader in haircare and beauty, with rapid global expansion. With $15M+ annual revenue, we are scaling towards $30M+ globally, and compliance is a key pillar of our success. Role Overview: We ar...

Role Overview: As a skilled Technical Writer joining the SCM II Technical Publication team, your primary responsibility will be to create clear, concise, and compliant technical content in accordance with regulatory documentation and federal aviation/authority guidelines. Your role will involve configuration management processing, documentation tracking, and software build preparation to ensure department practices align with released procedures. You will also be responsible for analyzing software documentation, resolving discrepancies, and addressing inquiries from customers and field engineering regarding software shipments and distribution requirements. Key Responsibilities: - Verify and ...

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 ...