CMC Regulatory Affairs Manager

Reasons to want this role

• You'll be joining a leading global pharmaceutical company who are committed to ongoing staff development
• This opportunity will see you working with global senior stakeholders to develop, execute and deliver the global regulatory strategy for products within oncology, immunology and haematology therapeutic areas
• Core global remit for regulatory dossier submissions with involvement in global projects

What will some of your key responsibilities be?

• Working with the international regulatory team (and core stakeholders across multiple other business areas), you will develop and contribute to the preparation of high-quality regulatory dossiers ensuring compliance with regulatory
• Frequently participates in interactions with the National Regulatory Health Authorities, the European Medicinal Agency (EMA) within the EU and other international regulatory agencies for product related dialogue
• You will work to ensure that the global regulatory product strategy is developed in alignment with Global Regulatory Affairs and the Global Project Team
• Works to ensure that product development programs and life-cycle plans are aligned with the company strategic business model as well as global and EU regulatory requirements 

What background & skills will you possess?

• A scientific degree (Bachelors or equivalent and above)
• The ability to network effectively with senior stakeholders and decision makers
• Exposure to international Regulatory Affairs and will have recent experience of EU Centralised Procedure
• In-depth appreciation of CTD modules 1-5 but especially 3-5
• Thorough understanding of drug discovery / drug development, drug manufacturing and marketing required
• Proven experience within regulatory affairs showing consistent progressing in your regulatory affairs career to-date

Park Street People Ltd is an Equal Opportunities Employer. We do not discriminate on the grounds of age, race, gender, disability, creed or sexual orientation and comply with all relevant UK legislation. We are acting as an Employment Business in relation to this role.