Full Time
Gurgaon
Posted 1 month ago

Sr. Manager-Regulatory Affairs- US/EU

Experience: -15+ Years
Location: Gurgaon

We are looking for an experienced and accomplished Senior Manager – Regulatory Affairs (CMC) with deep expertise in US and EU regulatory frameworks. The role will drive regulatory strategy, dossier submissions, and lifecycle management activities across these key markets, ensuring compliance and regulatory excellence. The ideal candidate will bring 15+ years of proven experience in regulatory affairs, with a strong command of CMC regulations and a successful track record of managing complex global submissions.

Roles & Responsibilities

  • Lead CMC review of technical documentation for regulatory filings in US and EU markets, including Gap Analysis and Remediation for Module 3 (CMC).

  • Develop and implement regulatory strategies, processes, and timelines for new product registrations, variations, renewals, and post-approval changes in the US and EU.

  • Oversee the preparation, review, and submission of CTD dossiers, ensuring conformance with FDA, EMA, and ICH guidelines.

  • Critically evaluate submission documentation for scientific accuracy, compliance, and internal consistency.

  • Provide regulatory intelligence by tracking changes in US and EU regulations, guidelines, and best practices.

  • Collaborate closely with cross-functional teams (R&D, QA, Manufacturing, and Commercial) to ensure regulatory strategies are aligned with business objectives.

  • Represent the company in discussions with regulatory authorities (FDA, EMA, and other relevant agencies).

    • Mentor and guide junior regulatory team members, fostering a culture of regulatory excellence.

Education & Experience

  • Master’s degree in Pharmacy (Pharma) or a related field.

  • 15+ years of regulatory affairs experience, with significant exposure to US and EU CMC submissions.

Knowledge, Skills & Abilities 

  • In-depth knowledge of US FDA, EMA, and ICH CMC guidelines.

  • Strong ability to interpret and analyze complex technical and scientific data.

  • Exceptional oral and written communication skills, with strong presentation abilities.

  • Proven leadership and mentoring skills with a collaborative, results-driven style.

  • Excellent problem-solving and decision-making capabilities.

  • Proficiency with document management systems and Microsoft Office Suite (Word, PowerPoint, Excel, Outlook).

  • Ability to manage multiple priorities and deliver high-quality outputs under pressure.

Why Join Us?

  • Play a key leadership role in shaping regulatory strategies for high-priority US and EU markets.

  • Opportunity to lead impactful submissions and contribute to global product approvals.

  • Exposure to cross-functional teams and business strategies.

  • Work in a collaborative environment with a focus on innovation and regulatory excellence.

Job Features

Job Category

Regulatory Affairs

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