Associate Director, Regulatory CMC
Jazz Pharmaceuticals
4 hours ago
Remote friendly (Raleigh, NC)
United States
Operations
Brief Description
- The Associate Director position, Regulatory Affairs Global CMC, is responsible for establishing global regulatory CMC strategies for commercial and development projects aligned with the global regulatory strategy. Leads CMC Regulatory Strategies across multi-disciplinary teams, including leading preparation of regulatory CMC submissions.
Essential Functions
- Lead activities including planning content, authoring where appropriate, and reviewing/approving Module 2 and 3 CTD sections of regulatory submissions (INDs, IMPDs, CTAs, MAAs, NDAs, BLAs, meeting requests, and briefing documents) to support Global Regulatory Team objectives.
- Provide in-depth reviews of protocols, reports, presentations, and documents for CMC Development or Commercial product teams as required.
- Represent Reg-CMC in regulatory agency interactions for team products; manage preparation and review of materials for these interactions.
- Provide timely updates of CMC Regulatory Strategy for the Global Regulatory Strategy document for assigned projects and secure functional support.
- Lead preparation and submission of agency response documents in a timely manner.
- Interact regularly with functional leaders on CMC regulatory strategy and regulatory agency interactions to ensure alignment.
- Lead GRA-CMC or GRA projects/initiatives with global business impact.
- Identify and lead continuous improvement opportunities for the GRA-CMC team and broader GRA team.
- Ensure regulatory compliance through change control and Regulatory Information Management procedures; complete regulatory impact assessments and execute appropriate implementation planning.
- Ensure compliance with company policies, procedures, and training expectations.
Required Knowledge, Skills, and Abilities
- Strategic understanding and application of regulations/guidelines for drug lifecycle activities.
- Knowledge of CMC regulatory requirements and ability to generate clear, well-argued regulatory positions.
- Experience with electronic Common Technical Document (eCTD) CMC regulatory documents (MAA, BLA, variations, responses, and CTAs/INDs).
- Understanding of FDA, EMA, and ICH guidelines.
- Exceptional interpersonal skills; able to work independently, within multi-disciplinary teams, and with external partners/regulators.
- Ability to influence and impact functional area and departmental practices.
Required/Preferred Education and Licenses
- BSc/BA with a minimum of eight (8) years of regulatory CMC or related experience.
- English language: written and verbal communication skills.
Benefits (if applicable)
- Eligible for medical, dental, and vision insurance; 401k retirement savings plan; and flexible paid vacation.
Application instructions
- If you are a current Jazz employee, apply via the Internal Career site.
- The Associate Director position, Regulatory Affairs Global CMC, is responsible for establishing global regulatory CMC strategies for commercial and development projects aligned with the global regulatory strategy. Leads CMC Regulatory Strategies across multi-disciplinary teams, including leading preparation of regulatory CMC submissions.
Essential Functions
- Lead activities including planning content, authoring where appropriate, and reviewing/approving Module 2 and 3 CTD sections of regulatory submissions (INDs, IMPDs, CTAs, MAAs, NDAs, BLAs, meeting requests, and briefing documents) to support Global Regulatory Team objectives.
- Provide in-depth reviews of protocols, reports, presentations, and documents for CMC Development or Commercial product teams as required.
- Represent Reg-CMC in regulatory agency interactions for team products; manage preparation and review of materials for these interactions.
- Provide timely updates of CMC Regulatory Strategy for the Global Regulatory Strategy document for assigned projects and secure functional support.
- Lead preparation and submission of agency response documents in a timely manner.
- Interact regularly with functional leaders on CMC regulatory strategy and regulatory agency interactions to ensure alignment.
- Lead GRA-CMC or GRA projects/initiatives with global business impact.
- Identify and lead continuous improvement opportunities for the GRA-CMC team and broader GRA team.
- Ensure regulatory compliance through change control and Regulatory Information Management procedures; complete regulatory impact assessments and execute appropriate implementation planning.
- Ensure compliance with company policies, procedures, and training expectations.
Required Knowledge, Skills, and Abilities
- Strategic understanding and application of regulations/guidelines for drug lifecycle activities.
- Knowledge of CMC regulatory requirements and ability to generate clear, well-argued regulatory positions.
- Experience with electronic Common Technical Document (eCTD) CMC regulatory documents (MAA, BLA, variations, responses, and CTAs/INDs).
- Understanding of FDA, EMA, and ICH guidelines.
- Exceptional interpersonal skills; able to work independently, within multi-disciplinary teams, and with external partners/regulators.
- Ability to influence and impact functional area and departmental practices.
Required/Preferred Education and Licenses
- BSc/BA with a minimum of eight (8) years of regulatory CMC or related experience.
- English language: written and verbal communication skills.
Benefits (if applicable)
- Eligible for medical, dental, and vision insurance; 401k retirement savings plan; and flexible paid vacation.
Application instructions
- If you are a current Jazz employee, apply via the Internal Career site.