Regulatory Affairs CMC Manager

Kenvue-1; Helsingborgs kommun; Hybrid; SEK 762,112 - 1,088,732; Full time

Job summary

Kenvue-1 is looking for a Regulatory Affairs CMC Manager in Helsingborg, Sweden to provide end-to-end oversight for Module 3/CMC new product development and life cycle management. The candidate will lead regulatory strategy development for new products, collaborating with various cross-functional teams to ensure compliance and operational excellence.

Successful applicants will possess a relevant Bachelor's Degree, have over 10 years of experience in regulatory affairs, and demonstrate strong project and people management skills.

Qualifications

• 10+ years experience in regulatory affairs or pharmaceutical product development.
• Expertise in regulatory classifications, especially for medicinal products and medical devices.
• Knowledge of global regulatory frameworks for pharmaceutical development.

Responsibilities

• End-to-end responsibility for Module 3/CMC new product development.
• Lead regulatory CMC strategy development in new product projects.
• Create and maintain partnerships with Regulatory Affairs and cross-functional teams.

Skills

Regulatory affairs experience

Pharmaceutical product development

Project management

Collaboration

Strong ownership

Proficiency in English

Education

Bachelor's Degree or higher

Job description

Regulatory Affairs CMC Manager

Role reports to: DIRECTOR Global & EMEA Regulatory Affairs OTC

Location: Europe/Middle East/Africa, Sweden, Skane, Helsingborg (Hybrid)

Responsibilities

• End-to-end responsibility for Module 3/CMC new product development and life cycle management
• Acts as regulatory CMC lead in new product development projects with responsibility for regulatory CMC strategy development and deployment
• Leads a team of regulatory affairs CMC product owners with responsibility for Module 3/CMC maintenance ensuring the success of life cycle management activities and roll‑out of existing products
• Provides technical leadership and expertise to cross‑functional R&D partners and life cycle management teams to support development of fit for purpose CTD Module 3/CMC documentation for marketing authorization applications and variations globally
• Develops strong partnerships with Regulatory Affairs partners, R&D, Marketing and Supply Chain
• Represents the Regulatory Affairs CMC function as appropriate in various regulatory and cross‑functional teams and technical fora
• Creates an environment of operational excellence through regulatory expertise, management of CMC product owners and collaboration with cross‑functional teams

Knowledge and Skills

• Relevant Bachelor’s Degree or higher
• 10+ years experience from regulatory affairs and/or pharmaceutical product development
• Expertise across regulatory classifications including medicinal products and medical devices as it relates to pharmaceutical CMC regulatory affairs
• Knowledge of regulatory frameworks globally as it concerns pharmaceutical product development and CMC requirements
• Experienced in developing and maintaining Module 2.3 and 3 and providing guidance to cross‑functional partners in authoring CTD documents
• Strong project and people management skills
• Highly collaborative and strong sense of ownership
• Proficiency in English