Global Regulatory Lead Partner

Responsibilities

• (This list is not exhaustive and may be supplemented or changed as necessary.)
• Ensure maintenance of global registrations for assigned products, including US and EU markets.
• Lead and execute regulatory activities supporting life‑cycle management, including submission strategy development, timeline definition, prioritization, assembly review, and identification of regulatory risks/challenges.
• Manage regulatory agency communications and submissions, including responses to agency questions, labeling negotiations, updates, and periodic reports.
• Coordinate SMEs to develop response strategies and author/review responses to health authority requests.
• Support labeling discussions, updates, and filings across CCDS, USPI, SmPC, and country‑specific labels.
• Provide regulatory input for annual reports, renewal applications, and aggregate safety reports (e.g., PSURs, PADERs).
• Conduct regulatory review for tender bid applications and assess country requests for registration deletions.
• Support preparation of ancillary documents required for product registrations in global markets.
• Follow through on agency commitments and ensure timely, high‑quality regulatory deliverables.
• Conduct research and review of US, EU, and other relevant regulatory guidelines, precedence, and competitive intelligence to inform regulatory strategy.
• Collaborate with Regulatory Operations, Clinical Safety, Labeling, Regulatory CMC, and other functional partners to ensure alignment and execution of regulatory strategy.
• QUALIFICATIONS AND REQUIREMENTS:
• Education :
• Bachelor's degree or higher in a relevant field such as pharmaceuticals, chemistry, or regulatory affairs.

Requirements

• 5+ years of experience in regulatory affairs and/or regulatory framework of major health authorities
• Thorough understanding of drug development process and the pharmaceutical industry and healthcare environment including regulatory requirements and policy trends. Understands scientific and clinical data sufficiently to ask questions and make suggestions about cross-functional topics to

Benefits

Additional Information

COMPANY DESCRIPTION: A career here is life-enhancing. At Syner-G, we enable our people to build careers that impact positively on their quality of life. Through our expertise, insight, consulting and management skills, we accelerate breakthrough science and delivery of life-enhancing therapies to more patients. We work across a diverse range of clients and projects, supporting many organizations from the most critical phases of the drug discovery and approval process through to commercialization. It is meaningful, varied and thought-provoking work with a strategic emphasis, a solutions-driven approach and significant, real-world outcomes, from science to delivery/success. To learn more about who we are and what drives us, watch our company video here . Underpinning this mission is a culture that aligns perfectly with what we want to achieve. We enable our people to grow, we support them in their learning and we reward them in so many different ways. In return, they play an instrumental role in maintaining our reputation across the globe as a strategic biopharma product development and delivery partner. Syner-G was recently honored with BioSpace's prestigious "Best Places to Work" 2026 award, for the third consecutive year, along with many other award-winning programs to make a career here truly life-enhancing. These recognitions are a testament to our commitment to fostering a positive and engaging work environment for our employees, with a particular emphasis on culture, career growth and development opportunities, financial rewards, leadership and innovation. At Syner-G, we recognize that our team members are our most valuable asset. Join us in shaping the future, where your talents are valued, and your contributions make a meaningful impact. For more information, visit www.Synergbiopharma.com POSITION OVERVIEW: The Global Regulatory Lead Partner supports Global Regulatory Leads in assigned therapeutic areas and serves as the accountable global regulatory point of contact for designated products. The individual provides regulatory leadership for life‑cycle management, maintenance of established products, and execution of global regulatory submissions. This role drives results through regulatory science expertise, strong communication, and analytical capabilities, ensuring high‑quality regulatory strategies and deliverables for assigned products. WORK LOCATION : Remote position based in Bangalore, Chennai, Hyderabad, or Mumbai, with pan-India operations.

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