Regulatory Affairs Executive - Pharma Industry
Location: Kurla
Company: AMN Life Science Pvt Ltd (EU-GMP Pharmaceutical Manufacturing -100% Export)
Experience: 2-3 Years | Industry: Pharmaceuticals (OSD)
Reports To: Manager Regulatory affairs
Role Type: Full-Time
Position Overview:
We are seeking a highly motivated and experienced Regulatory Affairs Executive to join our team. This individual will be responsible for ensuring that the company's products comply with all applicable regulatory guidelines. They should have a strong understanding of regulatory requirements, effective communication skills, and the ability to manage multiple projects, as per the requirement
Key Responsibilities:
- Regulatory Submissions: Prepare and submit regulatory filings (e.g., CTD/ACTD), and as per individual countries to regulatory agencies (MOH-ROW, FDA, EMA, etc.) to obtain approvals and ensure ongoing compliance with regulations.
- Regulatory Strategy: Develop and implement regulatory strategies for new and existing products in collaboration with cross-functional teams (e.g., R&D, Production, QA, clinical, marketing, legal) to ensure timely market access.
- Compliance Management: Monitor regulatory requirements and maintain up-to-date knowledge of regulations in relevant regions (e.g., EMA, Health Canada, TGA, ROW). Ensure company products and documentation comply with these requirements.
- Regulatory Intelligence: Keep track of regulatory changes and trends that may affect the company's products. Provide guidance to internal teams on how to address regulatory updates and changes.
- Labeling & Claims Review: Review product labeling, artworks to ensure compliance with regulatory standards.
- Cross-functional Collaboration: Collaborate with R&D, Clinical, Quality, Legal, and Manufacturing teams to ensure regulatory compliance in all stages of product development, production, and post-market surveillance.
- Regulatory Communication: Serve as the primary point of contact with regulatory authorities and agencies. Manage interactions, responses, and negotiations with regulatory agencies on product submissions and approvals.
- Risk Management: Conduct risk assessments and provide recommendations to mitigate any potential regulatory issues or delays that may arise during product development or post-market.
- Training and Support: Educate internal teams on regulatory requirements and provide support for regulatory audits and inspections.
Qualifications & Skills:
- Education: Bachelor's degree in Pharmacy, or Regulatory Affairs Certification).
- Experience: Minimum of 1 to 2 years of experience in regulatory affairs within the pharmaceutical industry.
- Regulatory Knowledge: Thorough understanding of regulatory guidelines, standards, and compliance processes (FDA, ICH, ROW ).
- Communication Skills: Strong written and verbal communication skills, with the ability to prepare clear and concise regulatory submissions and interact effectively with regulatory agencies.
- Project Management: Ability to manage multiple priorities and work effectively in cross-functional teams.
- Problem-Solving Skills: Demonstrated ability to identify issues, think critically, and provide innovative regulatory solutions.
- Attention to Detail: High level of accuracy in regulatory documentation and submissions.
- Technical Proficiency: Familiarity with regulatory submission platforms and tools (e.g., eCTD, regulatory tracking systems, document management systems).
Salary Range- 4.5LPA to 5.5LPA
Please feel free to connect @8976869261 and share your CV at [Confidential Information]/[HIDDEN TEXT]
