Senior Manager-Regulatory Affairs-EU/US

Experience:

Location:

Senior Manager – Regulatory Affairs (CMC)

US and EU regulatory frameworks

15+ years of proven experience

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.