Job Title: Regulatory Affairs Executive
Summary:
AMN Life Science Pvt. Ltd., a leading EU-GMP certified pharmaceutical manufacturer specializing in 100% export-oriented OSD formulations, is seeking a highly motivated and detail-oriented Regulatory Affairs Executive to join our dynamic team in Mumbai. This role offers an exciting opportunity to contribute to the regulatory success of our products across global markets. The ideal candidate will possess 1-3 years of experience in pharmaceutical regulatory affairs, a strong understanding of CTD/ACTD filing processes, and familiarity with global regulatory frameworks, including those of the FDA, EMA, TGA, Health Canada, and other ROW markets. If you are passionate about regulatory compliance and seeking a challenging role with opportunities for professional growth, we encourage you to apply.
About AMN Life Science Pvt. Ltd.
AMN Life Science Pvt. Ltd. is a rapidly growing pharmaceutical company committed to developing and manufacturing high-quality OSD formulations for the global market. Our state-of-the-art EU-GMP certified manufacturing facility ensures the highest standards of quality and compliance. We are dedicated to innovation and excellence in all aspects of our business, and we offer a supportive and collaborative work environment where employees can thrive.
Key Responsibilities:
As a Regulatory Affairs Executive, you will be responsible for a wide range of tasks related to regulatory submissions, compliance, and communication. Your key responsibilities will include:
- Regulatory Submissions:
- Prepare and submit comprehensive CTD/ACTD dossiers to various global health authorities (MOH-ROW, FDA, EMA, etc.).
- Ensure the accuracy, completeness, and compliance of all regulatory submissions.
- Regulatory Strategy:
- Contribute to the development of regulatory pathways for new and existing OSD products.
- Collaborate closely with cross-functional teams, including R&D, QA, Production, Clinical, and Legal, to ensure alignment of regulatory strategies.
- Compliance & Documentation:
- Monitor and stay updated on regional regulatory requirements (EMA, Health Canada, TGA, ROW).
- Maintain accurate and up-to-date regulatory documentation and Standard Operating Procedures (SOPs).
- Regulatory Intelligence:
- Track global regulatory updates, trends, and compliance changes.
- Provide guidance to internal teams on evolving regulatory expectations.
- Labeling & Artwork Review:
- Evaluate product labels, artworks, and marketing claims for compliance with applicable regulations.
- Regulatory Communication:
- Serve as a primary point of contact for communication with regulatory bodies.
- Manage queries, clarifications, and approval communications effectively.
- Risk Management:
- Conduct regulatory risk assessments and propose mitigation strategies.
- Training & Support:
- Support teams during audits and inspections.
- Train cross-functional stakeholders on relevant regulatory processes.
Qualifications & Skills Required:
To be successful in this role, you should possess the following qualifications and skills:
- Education: Bachelor’s degree in Pharmacy (B.Pharm) or Master’s degree in Pharmacy (M.Pharm). Regulatory Affairs certification is a plus.
- Experience: 1-3 years of experience in pharmaceutical regulatory affairs, preferably with OSD formulations.
- Regulatory Knowledge: Strong knowledge of FDA, EMA, ICH, and ROW guidelines.
- Communication Skills: Excellent written and verbal communication skills.
- Technical Skills: Hands-on experience with eCTD submissions and regulatory tracking systems.
- Attention to Detail: Strong attention to detail and commitment to accuracy.
- Project Management: Solid project management skills with the ability to prioritize and manage multiple tasks effectively.
- Teamwork: Ability to effectively multitask and coordinate with cross-functional teams.
Salary & Benefits:
AMN Life Science Pvt. Ltd. offers a competitive salary and benefits package, including:
- Salary Range: ₹4.5 – 5.5 LPA (commensurate with experience).
- Exposure to EU-GMP manufacturing standards.
- Opportunity to work with diverse global markets.
- Significant skill growth in regulatory strategy, submissions, and global compliance.
- On-site role fostering strong collaboration and visibility within the organization.
Job Location:
This is an on-site position located in Kurla, Mumbai, Maharashtra.
How to Apply:
If you are interested in this exciting opportunity and meet the qualifications outlined above, we encourage you to apply. Please submit your updated CV to the following contacts:
- Call / WhatsApp: +91 8976869261
- Email:
We look forward to hearing from you!