Our client is a Biopharma organisation with offices in Dublin. They are currently seeking a Director, CMC Regulatory Affairs, who will be responsible for providing tactical and strategic regulatory support for marketed products and development programs. A degree in Science with at least 8 years relevant CMC Regulatory experience is essential.
• As part of his/her responsibilities, the Director will collaborate with key functional areas (including Technical Operations and Quality) to prepare high quality, timely, and effective regulatory submissions in support of an approved NDA and MA and their corresponding IND/CTAs.
• In addition, he/she will coordinate and participate in regulatory agency interactions, as needed, including with the US FDA and various health agencies outside of the US.
• In this position, the Director will also support, either directly or in alliance with our clients partners/distributors, the submission of marketing applications to countries in greater Europe (non-EU), the Middle East, Africa, Asia, Mexica/South America and the Pacific. As part of his/her responsibilities, the Director will ensure that all assigned regulatory projects are prepared in adherence with US and any other relevant Health Authority regulations, procedures and guidelines.
• Develop and effectively communicate US and global drug development and product lifecycle strategies across regions and programs from a regulatory CMC perspective.
• Manage all CMC aspects of new and existing regulatory applications, including INDs, CTAs, NDAs, Marketing Authorizations, and Drug Master Files.
• Author and/or critically review CMC submission documents to support high-quality NDA supplements, MA variations, IND amendments, CTAs, annual reports and DMFs.
• Interface with regulatory agencies as needed, including routine communications, meeting requests, and preparation of supporting documentation.
• Support business development activities related to partnering/distributorship and licensing opportunities, including acting as a regulatory CMC resource for marketing application submissions worldwide and for due diligence assessments of in-licensing opportunities.
• Represent Regulatory Affairs at various project teams and working group meetings, particularly as it relates to CMC regulatory requirements, procedures and activities for the US, Europe and rest-of-world regions.
• Monitor emerging regulatory trends and precedents, and assess and communicate their potential impact on development programs and ongoing lifecycle plans.
• Assist in the oversight and management of external regulatory and development vendor resources, as needed.
• Ensure that all CMC activities are conducted in compliance with applicable regulations and guidelines.
• Coordinate and ensure submissions are prepared and completed to project plans, timelines and budget.
• Provide regulatory assessment on GMP requirements & questions
• Review and Draft SOPs, as required
• Bachelor’s Degree in chemistry, biochemistry or other scientific discipline (advanced degree or relevant certification a plus).
• Knowledge and skills acquired typically through a minimum of 8 years’ relevant industry experience in CMC Regulatory Affairs
• Technical knowledge of and experience with US and European regulations; regulatory knowledge and experience in other regions is a plus
• Experience working effectively in cross-functional teams with other internal and external stakeholders and communicating on behalf of regulatory affairs
• Ability to integrate scientific and regulatory considerations in developing and implementing regulatory strategies.
If you would like further Information you can contact the recruiter directly:
Karen Shiel | Tel: +353 (0) 1 5079256