Director, Cmc Regulatory Affairs

CPL

Dublin South

The Director, CMC Regulatory Affairs, will be responsible for providing tactical and strategic regulatory support for marketed products and development programs. Essential Duties and Responsibilities: • 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 and questions. • Review and Draft SOPs, as needed. Job Requirements: Education: • Bachelor’s Degree in chemistry, biochemistry or other scientific discipline (advanced degree or relevant certification a plus. Experience: • 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. For further detail contact Tina at +353 1 2784671. This job originally appeared on RecruitIreland.com.

2442 days ago