Assistant Manager Regulatory affairs

5 days ago

Rajkot, India Biotech Healthcare Full time

Role ObjectiveKey objective of this role is to prepare, review, and maintain regulatory documents in compliance with international standards and country-specific requirements. The role ensures timely preparation and updating of Technical Master Files, supports product registrations, manages post-market surveillance activities, and contributes to audit readiness. This position requires close collaboration with internal stakeholders to ensure consistent regulatory compliance across the organization.Desired Candidate Profile- Graduate/Postgraduate in Pharmacy, Biotechnology, Life Sciences, or a related discipline. - 6–9 years of experience in Regulatory Affairs, preferably in the pharmaceutical, biotechnology, or medical devices industry. - Strong understanding of international regulatory guidelines (e.g., EU MDR, US FDA, ISO standards). - Demonstrated experience in dossier preparation, technical file management, and compliance documentation. - Proficiency in MS Office and regulatory database searches.Role & Responsibilities1. Prepare and maintain Technical Master Files (TMFs) for all products, ensuring timely updates and regulatory accuracy. 2. Conduct scheduled reviews of TMFs to ensure consistency and alignment of technical content across product categories. 3. Prepare and update critical technical documents, including Risk Management Reports, Preclinical and Biological Evaluations, and Evaluation Summary Reports (ESRs). 4. Ensure timely preparation and updates of Post-Market Surveillance (PMS) reports, incorporating relevant findings. 5. Perform periodic searches of MAUDE and other relevant country-specific databases; summarize and integrate findings into PMS and Risk Management documentation. 6. Support audit preparations by ensuring completeness, accuracy, and readiness of technical files. 7. Review, compile, and finalize product registration dossiers in line with country-specific regulatory requirements. 8. Collaborate with the Regulatory Affairs team to monitor compliance activities, track file status, and provide daily progress updates. 9. Provide regulatory and documentation support to cross-functional teams in line with organizational priorities.Functional Skills Required- In-depth knowledge of regulatory requirements and submission processes across multiple markets. - Expertise in the preparation of dossiers, TMFs, PMS, and Risk Management documentation. - Strong documentation, review, and editing skills. - Familiarity with regulatory intelligence tools and database search methodologies. - Ability to prepare audit-ready documentation.Behavioral Skills Required- Strong attention to detail with high accuracy. - Effective communication and collaboration skills for cross-functional teamwork. - Ability to prioritize tasks and manage timelines under pressure. - Proactive problem-solving and decision-making skills. - Accountability and ownership of assigned deliverables.Team Size to be Handled:Individual Contributor role, reporting to the Sr. Manager – RA.Important Links:Website: https://biotechhealthcare.com/LinkedIn: https://www.linkedin.com/company/biotechhealthcare/Instagram: Biotech Vision CareBiotech is an Equal Opportunity Organization promoting diversity while ensuring no discrimination on any ground, including gender, race, religion, age, sexual orientation, disability, etc.

  • Regulatory Affairs

    2 days ago

    Rajkot, Gujarat, India Pramukh Staffing Full time ₹ 9,00,000 - ₹ 12,00,000 per year

    Job Description:Key Responsibilities:Prepare, compile, and submit CTD/eCTD dossiers for EMA and DGMED (France) including new registrations, renewals, and variations.Coordinate with internal teams (QA, QC, R&D, Supply Chain) for document collection and compliance.Liaise with regulatory agencies and local representatives in the EU and France for query...

  • Regulatory affairs specialist

    4 weeks ago

    Rajkot, India UpMan Placements Full time

    Core Job Responsibilities:Regulatory Submissions and compliancePrepare and submit various applications such as additional product permission, Layout approval, facility modification approval, technical person approval, Test license, amendments in licenses, State GMP and GLP certificate applications, post approval changes etc. to State FDAPrepare and submit...

  • Assistant Manager – Legal Department

    7 hours ago

    Rajkot, Gujarat, India Captain Tractors Pvt. Ltd. Full time ₹ 9,00,000 - ₹ 12,00,000 per year

    Company DescriptionCaptain Tractors Pvt. Ltd. is a leading manufacturer and exporter of compact tractors in India, catering to small farmers with affordable and high-quality mini tractors. Since 1994, our rugged, fuel-efficient, and eco-friendly compact tractors have been rigorously tested to meet industry standards and customized to meet customer demands....

  • Captain Tractors

    5 days ago

    Rajkot, India Captain Tractors Pvt Ltd Full time

    Job Description: Assistant Manager Legal DepartmentCompany DescriptionCaptain Tractors Pvt. Ltd. is a leading manufacturer and exporter of compact tractors in India, serving small farmers with affordable, high-quality mini tractors since 1994. Our rugged, fuel-efficient, and eco-friendly tractors are rigorously tested to meet industry standards and tailored...

  • Data coordinator

    4 weeks ago

    Rajkot, India ArtiXio Full time

    Company Description Artixio is a global consulting and services company specializing in Regulatory Affairs, Market Access, and Pharmacovigilance. We support pharmaceutical, biotech, cosmetics, medical device, and dietary supplements manufacturers in global regulatory compliance, product commercialization, and post-approval processes. Our services extend to...

  • Articled Assistant

    6 days ago

    Rajkot, Gujarat, India R B Shah and Associates Full time ₹ 4,00,000 - ₹ 8,00,000 per year

    Company DescriptionR B Shah and Associates is a Chartered Accountants firm based in Rajkot that provides comprehensive financial solutions. Specializing in areas such as Income Tax, GST, RERA, Companies Act, FEMA, Audit, Accounting, and Financial Planning, the firm is dedicated to delivering professional services with precision and expertise. R B Shah and...

  • Assistant Manager

    5 days ago

    Rajkot, India Deloitte Full time

    Your potential, unleashed.India’s impact on the global economy has increased at an exponential rate and Deloitte presents an opportunity to unleash and realize your potential amongst cutting edge leaders, and organizations shaping the future of the region, and indeed, the world beyond.At Deloitte, your whole self to work, every day. Combine that with our...

  • Assistant General Manager Sales Marketing

    6 days ago

    Rajkot, Gujarat, India Fox Energy Full time ₹ 15,00,000 - ₹ 25,00,000 per year

    Company Description:Fox Energy is a rapidly growing provider of sustainable solar captive plants, offering reliable energy solutions. We pride ourselves on delivering high-quality, customized energy solutions using the latest technology and best practices. Fox Energy is dedicated to continuous innovation and excellence in the renewable energy industry.Key...

  • Secretary

    2 days ago

    Mavdi, Rajkot, Gujarat, India VOLCUR ELECTRIX PVT. LTD. Full time

    **Designation: -** Secretary **Roles & Responsibilities: - ** Drafting, communication on behalf of company, smoothly running of internal & external communication, maintaining all departmental SOPs, creating & maintaining code of conduct, constitution ,core value books and content of website & other medias. Handling all organization’s affairs. **Report...

  • US Accountant Manager

    5 days ago

    Rajkot, India SourceIN Solutions Full time

    - Industry Experience: Must have worked with US CPA clients and be familiar with their specific financial reporting and compliance requirements. - Client-Facing Skills: Strong communication and interpersonal skills with a proven ability to engage with clients and manage relationships effectively. - End-to-End Accounting Knowledge: Strong understanding of all...