Regulatory Affairs, Global CMC Director
The Director position, Regulatory Affairs Global CMC will be responsible for leading GRA-CMC sub-teams responsible for managing and leading registration and CMC regulatory support for commercial and development projects worldwide. The Director will have a strategic role in driving CMC Strategies within the GRA function and across multi-disciplinary teams.
Essential Job Functions:
- Executing and supervising activities that include planning and co-ordination of the writing and reviewing Module 2 and 3 CTD sections of all regulatory submissions (INDs, IMPDs, CTAs, MAAs, NDAs, BLAs, meeting requests, and briefing documents). Ensuring that the internal review and submission of these items has been appropriately managed.
- Leads functional/department multi-disciplinary teams in complex, business critical projects to establish regulatory CMC strategies for commercial products, late, and early stage development programs. Resolves complex strategic issues in creative and effective ways.
- Provide in-depth reviews of protocols, reports, presentations, and documents, anticipating internal and/or external business challenges and/or regulatory issues.
- Ensure CMC related regulatory agency interactions for team products are managed professionally and in compliance with Corporate standards.
- Ensure the preparation and submission of responses to regulatory agencies have been managed appropriately and in a timely fashion. Ensure team timelines and development objectives are met.
- Regularly interacts with functional leaders, and in some cases senior leadership and/or business partners, on matters concerning functional area, business unit or additional business areas, including regulatory agency interactions.
- Lead GRA-CMC or GRA projects / initiatives that significantly impact the business globally.
- Ensure any changes to relevant global CMC regulations have been evaluated for impact to Jazz development and commercial activities. Ensure all development activities are in compliance with applicable current regulations and guidelines.
- Drives development and execution of strategic plans and objectives of the GRA-CMC and overall GRA function.
- Directs functional area to ensure delivery of broader department plans, including planning, staffing, budgeting and/or prioritization
- Identify and lead continuous improvement opportunities for the GRA-CMC team and the broader GRA team.
- Ensure continued regulatory compliance of products though ensuring teams adhere to the change control procedures and complete regulatory impact assessments for assigned commercial products.
- Ensure compliance with company policies, procedures and training expectations.
Required Knowledge, Skills, and Abilities
- Demonstrated understanding and strategic application of regulations and guidelines for drug development.
- Demonstrated knowledge of CMC regulatory and ability to generate clear, well-argued positions.
- Must have experience with electronic Common Technical Document CMC regulatory documents (MAA, BLA, variations, responses and CTAs/INDs).
- Demonstrated understanding of FDA, EMA and ICH guidelines.
- Exceptional interpersonal skills with the ability to work individually, within a multi-disciplinary team, as well as with external partners and regulators.
- Demonstrated ability to influence and impact their functional area and department practices.
Required/Preferred Education and Licenses
- BSc/BA with a minimum of ten years of regulatory CMC experience.
- English language - written and verbal communication skills.
Description of Work Environment
- Responsibilities may require a work schedule that may include working outside of “normal” work hours, in order to meet business demands.