If you’re looking for a high-impact regulatory affairs role in the pharmaceutical industry, this Regulatory Affairs Specialist – CMC position offers the perfect opportunity. This full-time remote role is ideal for professionals with strong experience in CMC submissions, GMP compliance, RIMS, and regulatory documentation management.
With growing demand for global regulatory support, this role allows you to work cross-functionally with technical, quality, and compliance teams while managing key regulatory submissions across global markets.
⭐ Key Responsibilities
As a Regulatory Affairs Specialist in CMC, you will:
- Prepare and author global CMC variation submissions, renewals, annual reports, tender applications, and GMP submissions.
- Ensure compliance with client submission timelines and technical requirements.
- Provide regulatory packages for internal review and manage updates as required.
- Finalize submission packages for publishing and QA review.
- Maintain and update internal systems including RIMS, eDMS, and change management tools.
- Respond to queries from partners and global health authorities.
- Collaborate cross-functionally across departments and regulatory partners.
- Identify out-of-scope contract activities and support modifications.
🎓 Required Qualifications
| Requirement | Details |
|---|---|
| Education | Bachelor’s/Master’s in Life Sciences or relevant health sciences. Regulatory Affairs degree is an advantage. |
| Experience | Minimum 2 years in Regulatory Affairs CMC within biotech/pharma. |
| Domain Skills | Experience with biologics, vaccines, gene therapy, or small molecules preferred. |
| Knowledge | Strong understanding of GMP guidelines and regulatory compliance. |
🛠 Technical Skills Required
- Hands-on experience with:
- RIMS (e.g., Veeva RIMS)
- eDMS platforms (e.g., Veeva, Documentum)
- TrackWise or similar Change Management systems
- Strong Microsoft Office and documentation writing expertise.
🤝 Competencies
- Excellent written and verbal communication skills.
- Strong organization and time-management skills.
- Ability to work independently with minimal supervision.
- Adaptable to cross-cultural global teams.
- Strong analytical and problem-solving mindset.
💼 Benefits of Working in This Role
✔ 100% Remote – Work from anywhere in India
✔ Exposure to global regulatory submissions
✔ Skill development in advanced regulatory systems
✔ Opportunity to work with cross-cultural teams
📍 Job Location
Remote — India
📢 How to Apply
