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Senior Manager/Director of Regulatory Affairs

4 months ago

Cambridge, United Kingdom Park Street People Full time
An innovative global pharmaceutical company is currently looking for a Regulatory Affairs Manager with CTA, UK/IE and early stage development experience to join their team on a 12 month temporary 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 and MA
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.
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