Regulatory Affairs Manager

An innovative global pharmaceutical company, based in Uxbridge, is currently looking for a Regulatory Affairs Manager with extensive CTA and ODD/PIPs/Scientific advice experience to join their team on an initial 12-month contract.

Working with the regulatory team (and core stakeholders across multiple areas), your role will be to provide regulatory strategy and guidance across the region and make sure that regulatory deadlines and approvals are achieved.

Other responsibilities include:

• You will develop, contribute and ensure the accurate preparation of high-quality regulatory documents needed to support clinical trials and medical products.
• Contributing regulatory guidance in order to enhance product development
• Ensuring that product development is aligned with the company’s strategy business model as well as global regulatory requirements
• Acting as a point of contact between the company and regulatory agencies whilst pertaining important information

Requirements

• Previous experience in Regulatory Affairs and Compliance particularly within pharmaceutical industry
• You will have a proven background working on CTA, ODD and PIPs
• Product lead experience
• Provision of scientific advisory support is essential
• Proven ability to create regulatory affairs strategy 
• Exposure of Regulatory Affairs legislation and procedures
• Strong communication and interpersonal skills

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.