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Syneos Health
Syneos Health is inviting applications for the position of Regulatory Consultant (EU Market, Module 3) at its Pune/Pimpri-Chinchwad location. Candidates with strong experience in Regulatory Affairs, CMC Module 3 authoring, and EU market submissions are encouraged to apply.
About Syneos Health
Syneos Health is a leading fully integrated life sciences services organization that helps pharmaceutical, biotechnology, and medical device companies accelerate the development and commercialization of innovative therapies. With more than 25,000 professionals worldwide, Syneos Health is committed to improving patient outcomes through clinical development, commercialization, and consulting services.
Job Details
| Particulars | Details |
|---|---|
| Position | Regulatory Consultant (EU Market, Module 3) |
| Location | Pune / Pimpri-Chinchwad Area |
| Department | Regulatory Affairs |
| Qualification | M.Pharm or Master’s Degree in Science-related field |
| Experience | 4–5 Years |
| Market Exposure | EU & GCC Markets |
| Employment Type | Full-Time |
Key Responsibilities
The selected candidate will be responsible for:
- Authoring and reviewing CMC Module 3 documentation.
- Managing post-approval variations and lifecycle management activities.
- Conducting regulatory gap assessments and product development planning.
- Preparing technical and administrative components of regulatory submissions.
- Supporting INDs, product registrations, and post-approval maintenance activities.
- Participating in regulatory agency interactions and scientific advice meetings.
- Managing day-to-day regulatory activities within agreed timelines and budgets.
- Collaborating with multidisciplinary project teams throughout the product lifecycle.
- Acting as a subject matter expert for regulatory troubleshooting and guidance.
- Supporting proposal preparation and business development activities.
- Ensuring compliance with global regulatory requirements and internal procedures.
- Preparing training materials and sharing regulatory best practices.
- Supporting internal and external audits.
- Contributing to SOP development and process improvement initiatives.
Required Skills & Experience
Candidates should possess:
- Minimum 4–5 years of experience in Regulatory Affairs.
- M.Pharm degree or equivalent science-related Master’s qualification.
- Hands-on experience in CMC Module 3 authoring.
- Experience handling post-approval variations and lifecycle management activities.
- Regulatory submission experience for EU and GCC markets.
- Knowledge of CTD/eCTD submission requirements.
- Strong analytical and problem-solving skills.
- Excellent written and verbal communication skills.
- Advanced proficiency in Microsoft Office applications.
- Ability to manage multiple projects simultaneously.
Preferred Qualifications
- Experience in preparing regulatory submissions such as IND, NDA, MAA, PMA, and CTD dossiers.
- Strong understanding of global regulatory requirements.
- Experience working in cross-functional and international project teams.
- Good quality management and project coordination skills.
Why Join Syneos Health?
Syneos Health offers:
- Career development and growth opportunities.
- Technical and therapeutic area training programs.
- Competitive rewards and recognition programs.
- Inclusive and collaborative work culture.
- Opportunities to work on global regulatory projects.
- Exposure to international regulatory markets and submissions.
How to Apply
Interested and eligible candidates can apply through the official careers portal of Syneos Health and explore this exciting opportunity to advance their career in Regulatory Affairs.
APPLY HERE
To apply for this job please visit syneoshealth.wd12.myworkdayjobs.com.
