Genedrift: Senior Executive – Regulatory Affairs
Summary:
Genedrift is seeking a highly motivated and experienced Senior Executive to join our Regulatory Affairs team. This pivotal role will be responsible for preparing, reviewing, and submitting regulatory dossiers for a diverse range of products including drugs, medical devices, vaccines, injectables, and biosimilars. The ideal candidate will possess a strong understanding of both local and international regulatory guidelines, excellent communication skills, and a proven track record of success in navigating the complexities of regulatory submissions. This is an exceptional opportunity to contribute to a dynamic and innovative company at the forefront of life sciences.
About Genedrift:
Genedrift is a forward-thinking company dedicated to innovation and excellence in the life sciences. We are committed to developing and delivering high-quality products that improve patient outcomes. Our collaborative and supportive team culture fosters professional growth and provides opportunities to contribute to impactful projects.
Job Description:
As a Senior Executive – Regulatory Affairs at Genedrift, you will play a crucial role in ensuring the regulatory compliance and successful market launch of our products. You will be responsible for managing the entire regulatory lifecycle, from initial dossier preparation to post-market surveillance.
Key Responsibilities:
- Dossier Preparation and Submission: Prepare, review, and submit comprehensive regulatory dossiers for a variety of products, including drugs, medical devices, vaccines, injectables, and biosimilars, to relevant regulatory agencies.
- Regulatory Compliance: Ensure strict adherence to all applicable local and international regulatory requirements, including but not limited to FDA, EMA, and other relevant authorities.
- Liaison with Regulatory Authorities: Act as a primary point of contact with regulatory authorities, addressing inquiries, providing clarifications, and negotiating approvals to ensure timely and efficient product registration.
- Internal Stakeholder Collaboration: Work closely with internal stakeholders, including research and development, manufacturing, quality control, and marketing teams, to ensure regulatory considerations are integrated throughout the product lifecycle.
- Product Lifecycle Management: Support the lifecycle management of products, including handling renewals, variations, and post-approval commitments, ensuring continued compliance and market access.
- Regulatory Intelligence: Maintain up-to-date knowledge of evolving regulatory guidelines, industry trends, and competitive landscapes, proactively identifying potential impacts and developing mitigation strategies.
- Documentation and Record Keeping: Maintain accurate and comprehensive regulatory documentation, ensuring compliance with record-keeping requirements and facilitating audits and inspections.
- Risk Assessment: Conduct regulatory risk assessments and develop strategies to minimize potential regulatory hurdles and delays.
- Training and Mentorship: Provide training and mentorship to junior team members on regulatory requirements and best practices.
Qualifications & Experience:
- A minimum of 3 years of demonstrable work experience in regulatory affairs within the pharmaceutical, medical device, or biotechnology industry.
- Hands-on experience with a range of product types, including drugs, medical devices, vaccines, injectables, and/or biosimilars. Specific experience in one or more of these areas is highly desirable.
- In-depth knowledge of regulatory guidelines, submission formats, and compliance processes, including familiarity with relevant regulations (e.g., 21 CFR, EU Directives).
- Proven ability to interpret and apply regulatory guidelines to specific product development and submission strategies.
- Excellent written and verbal communication skills, with the ability to effectively communicate complex regulatory information to both technical and non-technical audiences.
- Strong documentation skills, with meticulous attention to detail and accuracy.
- Proficient project management skills, including the ability to prioritize tasks, manage timelines, and meet deadlines.
- Excellent problem-solving skills and the ability to work independently and as part of a team.
- Bachelor’s degree in a relevant scientific discipline (e.g., pharmacy, biology, chemistry) is required. A Master’s degree or advanced certification in regulatory affairs is a plus.
Benefits:
- Competitive salary commensurate with experience and performance-based incentives (INR 6–10 LPA).
- Comprehensive benefits package, including health insurance and paid time off.
- Significant opportunities for professional growth and development in a dynamic and innovative environment.
- Exposure to global regulatory standards and submissions, broadening your expertise and career prospects.
- Collaborative and supportive team culture that fosters learning and knowledge sharing.
- The chance to make a real difference in the lives of patients by contributing to the development and approval of life-changing products.
How to Apply:
If you are a passionate and driven regulatory affairs professional with the skills and experience to excel in this role, we encourage you to apply. Please submit your CV to [[email protected]] or [[email protected]].
Please ensure your application clearly highlights your experience in regulatory affairs, particularly your experience with drugs, medical devices, vaccines, injectables, or biosimilars. We look forward to hearing from you!
Note: Please refrain from applying if you are a fresher.