Regulatory Affairs Manager CMC to a pharmaceutical company, region Öresund

New possibility as Regulatory Affairs Manager, CMC at a pharmaceutical company in region Öresund!

Summary:

As Regulatory Affairs Manager – CMC, you will play a key role in driving Company development projects in collaboration with our international CDMOs. You will act as the Regulatory Affairs Project Leader, ensuring that our products are developed and registered in compliance with European regulatory requirements. The role combines strategic CMC leadership with hands-on regulatory execution in a dynamic, entrepreneurial environment.

Tasks:

• Act as Regulatory Affairs Project Leader for development projects performed by CDMOs, ensuring full regulatory compliance throughout the product lifecycle.

• Provide strategic CMC input to formulation development, analytical method validation, scale-up and technology transfer activities.

• Lead and coordinate successful submissions and approvals of new marketing authorisation applications (DCP/MRP/National).

• Provide regulatory input to in-licensing evaluations, evaluations of new development projects and due diligence activities (eg. performing regulatory pre-studies and reviewing dossiers)

• Review and/or compile and submit dossiers to European health authorities.

• Develop, maintain and continuously improve SOPs, templates and internal RA processes to ensure consistency and efficiency.

• Act as Regulatory Business Partner, providing clear and solution-oriented advice in cross-functional discussions with Business Development, Quality, Operations and Commercial teams.

• Serve as the primary regulatory contact for manufacturing partners on CMC-related matters.

• Ensure systematic archiving and documentation of regulatory files and correspondence.

Responsibilities:

• Ensure that all regulatory deliverables within assigned projects are completed on time, to high quality, and in line with European regulatory and quality standards.

• Drive implementation of effective regulatory strategies for new product development and life cycle management.

• Represent Regulatory Affairs in internal and external project meetings, ensuring alignment of regulatory strategy with business and technical objectives.

• Proactively identify regulatory risks and opportunities and propose mitigations or alternative approaches.

• Foster a culture of collaboration and regulatory excellence across internal teams and external partners.

Qualifications & Profile:

• M.Sc. or Ph.D. in Pharmacy, Chemistry or related life science field.

• Minimum 5 years of experience within Regulatory Affairs, preferably from a generic or CDMO environment.

• Solid understanding of CMC and pharmaceutical development for generics (formulation, process validation, stability, analytical methods).

• Experience with DCP/MRP/National procedures and electronic submissions (eCTD).

• Strong communication and coordination skills; ability to work effectively in cross-functional and multicultural environments.

• Solution-oriented mindset, able to balance regulatory compliance with business objectives.

Contact me for more information about the company and the role!