Senior Regulatory Affairs Director

5 days ago

London, Greater London, United Kingdom Lifelancer Full time

Otsuka Pharmaceutical Europe seeks a highly skilled Director CMC Regulatory Affairs to provide expertise on CMC regulatory matters for investigational and marketed products.

The successful candidate will establish CMC regulatory strategies, ensuring Otsuka's products comply with global regulatory requirements. They will anticipate, develop, and recommend strategies for submission preparation and review, providing guidance on scientific/technical requirements and regulations.

In this role, you will:

  • Develop and maintain collaborative relationships with OPCJ CMC RA, Factory, Quality, MSRD, partners, and contract manufacturers
  • Represent Otsuka at regulatory authority CMC meetings and lead interactions with regulatory authorities
  • Monitor, interpret, and provide guidance on current developments in guidances, regulations, practices, and policies in the CMC and GMP area

You will be responsible for preparing and reviewing CMC and GMP related documents, labels, and labeling for submission to regulatory authorities. Your proficiency with tools and systems, such as Reg Intel, EQMS, and EDMS, is essential for success in this role.

This position offers a competitive salary of $120,000 - $160,000 per annum, depending on experience, plus comprehensive benefits, flexible working practices, and remote work opportunities. If you are passionate about regulatory affairs and have a strong background in CMC, we encourage you to apply.

Lifelancer is an equal opportunity employer and celebrates diversity. We are committed to creating an inclusive environment for all employees and welcome applications from qualified candidates regardless of their background or identity.

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