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Senior Regulatory Affairs Manager - Remote Working

map_markerUxbridge Coin£45.00 to £47.00 per hour + Holiday Pay

Vacancy summary

Vacancy summary

Reference: 08875

Job Type: Temporary

Date Posted: 23 November 2020

  • Working for a global pharmaceutical company
  • Excellent opportunity to work for an innovative company at the forefront of their therapy area
  • Working as a regulatory lead on a product

A global pharmaceutical company, based in Uxbridge, is currently looking for a Senior Regulatory Affairs Manager to join their team on an initial 12-month contract. The role is currently offering remote working.

You will be a confident Regulatory Lead looking to work in an innovative therapy area, developing and defining regulatory plans across multiple products.

Working with the regulatory team (and core stakeholders across multiple areas), your role will be to operate as a Regulatory Lead, providing centralised 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
  • As the regulatory lead, you will sit with the wider project team, providing guidance on how regulatory strategy should be implemented 
  • 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

  • You will be able to clearly demonstrate experience in developing centralised regulatory plans and strategy
  • Strong communication and stakeholder management experience,   you will be able to demonstrate working in project teams, where you have guided/advised on the implementation of your strategy/regulatory plan
  • Previous experience in Regulatory Affairs particularly within pharmaceutical industry
  • Centralised Regulatory Affairs experience
  • Strong strategic experience within Regulatory Affairs
  • Exposure to Regulatory Affairs full cycle and submissions procedures such as CTA, PIPs and MAAs is advantageous
  • 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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