Job Title:
Assistant Manager – Regulatory Affairs (EU & UK)
Location:
Gurgaon, Haryana (India)
Experience:
4–6 Years
Qualification:
Master’s Degree in Pharmacy (M.Pharm or equivalent)
Role Overview
We are seeking a proactive and detail-oriented
Assistant Manager – Regulatory Affairs
to join our Global Regulatory team. The ideal candidate will be responsible for driving CMC documentation, regulatory submissions, and lifecycle management for the
EU & UK markets
, ensuring compliance with regional and international guidelines.
Key Responsibilities
- Conduct comprehensive CMC reviews of technical documentation for regulatory filings across the EU and UK markets.
- Perform Gap Analysis and Remediation for Module 3 (CMC) sections to ensure submission readiness and alignment with regulatory standards.
- Develop and implement regulatory strategies, processes, and timelines for the preparation and submission of Marketing Authorization (MA) applications.
- Prepare and compile new CTD dossiers, variations, and renewals ensuring full compliance with applicable EMA/MHRA regulatory requirements and internal quality standards.
- Critically review documentation to ensure internal consistency, compliance with regulatory expectations, and support regulatory excellence.
- Collaborate with cross-functional teams including R&D, QA, QC, Manufacturing, and external stakeholders for timely and accurate data collation and submissions.
- Ensure effective and efficient communication across teams to facilitate streamlined project execution and meet submission timelines.
- Maintain high-level knowledge of current country-specific regulations, keeping track of regulatory updates through respective health authority websites (e.g., EMA, MHRA).
Education & Experience
- Master’s degree in Pharmacy or equivalent qualification.
- 4 to 6 years of relevant experience in Regulatory Affairs, with a focus on EU and/or UK submissions.
- Equivalent combinations of education, training, and practical experience may also be considered.
Key Skills & Competencies
- Strong technical skills in data analysis and interpretation of regulatory documentation.
- Excellent interpersonal and problem-solving skills with a proactive and solution-oriented approach.
- Effective negotiation and communication skills for liaising with internal teams and external agencies.
- Proficient in drafting and reviewing documents in line with global, regional, and national regulatory standards.
- Expertise in document management systems and tools like Excel, Outlook, PowerPoint, and Word.
- Strong presentation and reporting skills with the ability to explain complex regulatory concepts clearly.
- Demonstrated ability to analyze data systematically, apply regulatory logic, and compile well-organized submissions.
- Collaborative, results-driven, and self-motivated with the flexibility to adapt to shifting priorities.
- Capable of delivering high-quality outputs under pressure and within aggressive timelines.
Other Requirements
- Flexibility to work in cross-time-zone schedules, as needed to support global project coordination or agency interactions.
Why Join Us?
Be part of a high-performing regulatory team that plays a critical role in bringing impactful pharmaceutical products to patients globally. Work in a collaborative, fast-paced environment where your expertise shapes international market access strategies.
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