Manager – Regulatory Affairs

DDReg Pharma

Quality Driven by Passion

Full Time

Gurgaon

Posted 6 months ago

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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Regulatory Affairs