Senior Manager, Global Regulatory Affairs, CMC

Jazz Pharmaceuticals is a global biopharma company whose purpose is to innovate to transform the lives of patients and their families. We are dedicated to developing life-changing medicines for people with serious diseases — often with limited or no therapeutic options. We have a diverse portfolio of marketed medicines, including leading therapies for sleep disorders and epilepsy, and a growing portfolio of cancer treatments.

About the role

The Senior Manager, Regulatory Affairs Global CMC will be responsible for managing registration and CMC regulatory support for commercial and/or development projects worldwide for biological products.

Responsibilities

• Manage the preparation and review of Module 2 and 3 CTD sections of regulatory submissions as assigned (INDs, IMPDs, CTAs, MAAs, NDAs, BLAs, meeting requests, and briefing documents) for biological products, in support of Global Regulatory Team objectives.
• Participate and support as an active member of a multi-disciplinary team to establish Regulatory CMC strategies for commercial products, late- and early-stage development programs, under the supervision of GRA-CMC leadership.
• Through the performance of risk assessments, work with GRA-CMC leadership to identify and communicate potential risks associated with strategy scenarios to the multi-disciplinary team and the Global Regulatory Team.
• Coordinate the preparation and timely submission of responses to regulatory agencies.
• Manage timelines to ensure approvals are timely and development objectives are met.
• May act as regulatory CMC representative at meetings with business partners and may contribute to meetings with regulatory agencies for CMC related issues.
• Ensure continued regulatory compliance of products through adherence to the change control procedures, regulatory information management procedures and completion of regulatory impact assessments for assigned commercial and development products.
• Maintain current regulatory product information to support product release for assigned clinical and commercial products.
• Verify electronic publishing of regulatory submissions.
• Identify & support continuous improvement opportunities for the GRA-CMC team and the broader GRA team.
• Ensure compliance with company policies, procedures and training expectations.

Requirements

• Demonstrated understanding and strategic application of regulations and guidelines for drug lifecycle preferably for biological products.
• Solid working 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.
• Strong interpersonal skills with the ability to work individually, within a multi-disciplinary team, as well as with external partners and regulators.
• BSc/BA with regulatory CMC or related experience.
• English language - written and verbal communication skills.

Pay

For US based candidates, the full and complete base pay range is: $140,000.00 - $210,000.00. Individual compensation paid within this range will depend on qualifications, skills, relevant experience, job knowledge, and other pertinent factors.

Benefits

• Discretionary annual cash bonus or incentive compensation (depending on the role).
• Discretionary equity grants in accordance with Jazz's Long Term Equity Incentive Plan.
• Medical, dental and vision insurance.
• 401k retirement savings plan.
• Flexible paid vacation.

For more information on our benefits offerings, visit Jazz Pharmaceuticals Benefits.