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Akums, one of India’s leading pharmaceutical manufacturers, is hiring a Regulatory Affairs Associate (CMC) with 3–5 years of formulation regulatory experience specifically for EU/UK markets. This is an excellent opportunity for candidates seeking career growth in CMC regulatory submissions, dossier preparation, and EU/UK regulatory compliance.
If you are looking to relocate to Haridwar and meet the eligibility criteria, this could be the ideal step forward in your regulatory affairs career.
📌 Key Responsibilities
- Prepare, review, and submit CMC dossiers for EU/UK markets.
- Manage Module 2 and Module 3 documentation for formulation products.
- Coordinate with cross-functional teams for data compilation and gap analysis.
- Ensure compliance with EMA/MHRA guidelines and regulatory expectations.
- Manage deficiency responses, lifecycle updates, and post-approval changes.
- Track regulatory submissions, approvals, and change controls.
🎓 Required Qualifications & Experience
- 3–5 years of experience in Formulation Regulatory Affairs (CMC).
- Strong understanding of EU/UK regulatory frameworks.
- Experience in dossier preparation: eCTD, NeeS, technical documentation, and quality summaries.
- Ability to interpret regulatory guidelines and perform impact assessments.
- Excellent communication and documentation skills.
💼 Job Location
📍 Haridwar, Uttarakhand (On-site)
Candidates willing to relocate are encouraged to apply.
🎁 Benefits of Working with Akums
- Opportunity to work with India’s top pharmaceutical manufacturer.
- Exposure to international regulatory submissions.
- Competitive salary & career advancement opportunities.
- Supportive professional environment and structured training.
📬 How to Apply
Interested and eligible candidates can share their updated resume through:
- Email: yogesh.sonawane@akums.in
- WhatsApp: 9960976929