Senior Regulatory Affairs Consultant II (Future Opportunities)

Responsibilities

• (This list is not exhaustive and may be supplemented or changed as necessary.)
• Demonstrating strong ownership, initiative and accountable for the delivery of all regulatory milestones for assigned products through the product lifecycle.
• Actively contributes to strategic discussions and decision-making processes.
• Possesses excellent communication skills, exhibit strong leadership potential in multicultural settings and ability to communicate complex issues in a succinct and logical manner.
• Contribute to the development of CMC regulatory strategies and submission documents for post approval pharmaceutical products with the ability to execute tasks independently in accordance with US, EMA & global regulations and ICH guidance.
• Execute regulatory strategies by leading the authoring and review of global CMC submissions and ancillary documentation to support post-approval supplements/variations, and responses to health authority questions using established business process and submissions tools.
• Collaborate with CLIENT and external partners to support compliant execution of change management and conduct all activities with an unwavering focus on regulatory conformance.
• Demonstrated flexibility in responding to changing priorities or dealing with unexpected events.
• Coordinate timely and accurate responses to the Regulatory agency questions (RTQs) on CMC content.
• Responsible for regulatory operational activities including organizing, tracking, and sending submissions for publishing for the US and other International Markets.
• Provide regulatory change control assessments and strategize post-approval implementation and applicable regulatory reporting.
• Perform regulatory reviews of technical/development documents such as certificate of analysis (CoA), analytical test methods, specifications, and stability protocol/report/data.
• Support and prepare other CMC ad-hoc requests at the pre & post-approval stage of the product.
• Author/compile documentation for regulatory submission packages including post approval submissions, information request updates, and new markets registration, source of supply changes for submission to global regulatory agencies.
• Proactively ensure all regulatory documents are prepared accurately and completed in a timely manner towards project completion.
• Maintains knowledge of current FDA, EU, global regulations and guidance's applicable to marketed products.
• Assess and communicate potential regulatory risks and product mitigation strategies.
• Identify, communicate and escalate potential regulatory issues to concerned CMC team/ma

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: Syner-G seeks a Manager/Senior Manager of Regulatory Affairs to provide regulatory consulting to a large, global pharmaceutical Client in the areas of Chemistry, Manufacturing, and Controls (CMC), to ensure compliance with FDA, EMA, and global regulatory requirements (with a focus on post-approval). A successful candidate will have a proven track record of applying scientific principles to solve challenges. WORK LOCATION : Remote position based in Bangalore, Chennai, Hyderabad, or Mumbai, with pan-India operations.

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