Senior Manager, Global Regulatory Affairs, CMC

BioSpace; California (MO); On-site; USD 140,000 - 210,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401k plan

Paid time off

Job summary

Jazz Pharmaceuticals, Inc. is seeking a Senior Manager, Regulatory Affairs Global CMC to lead regulatory CMC support for biological products worldwide, including submissions and strategy development.

The role collaborates with the Global Regulatory Team, external partners, and regulators to ensure timely approvals and ongoing compliance. Qualified candidates have CMC regulatory expertise and experience with FDA, EMA, and ICH guidelines.

Qualifications

• 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.

Responsibilities

• Managing 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.
• Maintenance of 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.

Skills

Regulatory strategy

CMC regulatory knowledge

FDA/EMA/ICH guidelines

Interpersonal skills

Regulatory submissions (MAA/BLA)

Education

BSc/BA with regulatory CMC or related experience

Tools

eCTD publishing tools

Job description

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. Our patient-focused and science-driven approach powers pioneering research and development advancements across our robust pipeline of innovative therapeutics in oncology and neuroscience. Jazz is headquartered in Dublin, Ireland with research and development laboratories, manufacturing facilities and employees in multiple countries committed to serving patients worldwide. Please visit www.jazzpharmaceuticals.com for more information.

Brief Description

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.

Essential Functions

• Managing 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.
• Maintenance of 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.

Required Knowledge, Skills, And Abilities

• 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.

Required/Preferred Education And Licenses

• BSc/BA with regulatory CMC or related experience.
• English language - written and verbal communication skills.

Jazz Pharmaceuticals is an equal opportunity/affirmative action employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any characteristic protected by law.

FOR US BASED CANDIDATES ONLY

Jazz Pharmaceuticals, Inc. is committed to fair and equitable compensation practices and we strive to provide employees with total compensation packages that are market competitive. For this role, the full and complete base pay range is: $140,000.00 - $210,000.00

Individual compensation paid within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, and other pertinent factors. The goal is to ensure fair and competitive compensation aligned with the candidate's expertise and contributions, within the established pay framework and our Total Compensation philosophy. Internal equity considerations will also influence individual base pay decisions. This range will be reviewed on a regular basis.

At Jazz, your base pay is only one part of your total compensation package. The successful candidate may also be eligible for a discretionary annual cash bonus or incentive compensation (depending on the role), in accordance with the terms of the Company's Global Cash Bonus Plan or Incentive Compensation Plan, as well as discretionary equity grants in accordance with Jazz's Long Term Equity Incentive Plan.

The successful candidate will also be eligible to participate in various benefits offerings, including, but not limited to, medical, dental and vision insurance, 401k retirement savings plan, and flexible paid vacation. For more information on our Benefits offerings please click here: https://careers.jazzpharma.com/benefits.html.