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Regulatory Affairs Manager

Park Street People

Greater London

On-site

GBP 125,000 - 150,000

Full time

26 days ago

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Job summary

An innovative global pharmaceutical company seeks a Regulatory Affairs Manager to join their team on a 12-month temporary contract. This role involves providing regulatory strategy and guidance, ensuring compliance with deadlines and approvals, and acting as a liaison with regulatory agencies. The ideal candidate will have a strong background in Regulatory Affairs and Compliance, particularly within the pharmaceutical sector, and will be responsible for developing high-quality regulatory documents to support clinical trials and medical products. This is a fantastic opportunity to contribute to impactful projects in a dynamic environment.

Qualifications

  • Experience in Regulatory Affairs and Compliance in the pharmaceutical industry.
  • Proven background in CTA, MA, and labelling.

Responsibilities

  • Develop and prepare high-quality regulatory documents for clinical trials.
  • Provide regulatory strategy and guidance across the region.

Skills

Regulatory Affairs
Compliance
Communication Skills
Interpersonal Skills
Regulatory Strategy
Scientific Advisory Support

Job description

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An innovative global pharmaceutical company is currently looking for a Regulatory Affairs Manager with CTA, EU and labelling 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 the pharmaceutical industry.
  • You will have a proven background working on CTA, MA and labelling.
  • Provision of scientific advisory support is essential.
  • Proven ability to create regulatory affairs strategy.
  • Exposure to 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.

Seniority level

Mid-Senior level

Employment type

Full-time

Job function

Science

Industries

Pharmaceutical Manufacturing and Biotechnology Research

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