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NEW CONTRACT role for a ***Regulatory Manager or Sr Reg Manager***Do you have Phase I, Phase II CTAs?

Company: Advanced Regulatory (UK & Europe)
Location: UK, M4 Corridor
Reference: Oli/01326
Closing Date: 26 Aug 18
Type: Contract
Salary (£): Competitive
Benefits: On Application

Job Summary:

We have a 9 months contract role for a Regulatory Scientist with a dynamic and expanding Biopharmaceutical company based in Berkshire, UK. Good rate is available for the right candidate! You will prepare and deliver regulatory operational plans for assigned projects/products within a specific region, but also provide strategic and operational regulatory input and guidance in cross-functional teams.

Requirements:

NEW CONTRACT role for a ***Regulatory Manager or Sr Reg Manager***Do you have Phase I, Phase II CTAs?

We have a 9 months contract role for a Regulatory Scientist with a dynamic and expanding Biopharmaceutical company based in Berkshire, UK.

Good rate is available for the right candidate!

You will prepare and deliver regulatory operational plans for assigned projects/products within a specific region, but also provide strategic and operational regulatory input and guidance in cross-functional teams.

In this role you will manage quality regulatory submissions to agreed project targets and work flexibly within and across regions to provide broad operational support, to ensure the delivery of product team and business objectives.

Major Accountabilities and Responsibility:

  • Support the GRL for the delivery of timely approvals and product information in keeping with the needs identified by the business and markets and in compliance with relevant procedures and regional/local country regulations.
  • Lead the planning, preparation and delivery of both simple and complex submissions throughout the product’s life cycle form either a global and/or regional perspective.
  • Liaise proactively with the functions and participate as a member of cross-functional delivery teams for complex submissions, providing regulatory advice.
  • Identify potential regulatory risks to the operational plan and propose options to mitigate risks.
  • Provide regulatory expertise on regulatory submissions, health authority briefing documents and response documents.
  •  Assume assigned responsibilities for routine and non-routine contact with health authorities and affiliates to support the GRL.
  •  Maintain awareness of competitors’ activities and share potential impact these activities may have on the product development program.
  • Delivers project assignments supporting the business e.g. representation on functional workstreams.
  •  Ensure that appropriate, up-to-date records are maintained for compliance.
  •  Assist in development of regulatory standards and SOPs.
  • Provide input into Regulatory Strategy Plans and project budget as delegated by GRL.
  •  Assist in due diligence activities for in-licensing opportunities.
     

The ideal candidate for this role will have 5+ years of pharmaceutical experience with knowledge of assigned regional regulatory procedures and legislation. Someone, who can build effective partnerships, is results focused and self-driven, able to identify opportunities as well as obstacles and take actions.

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If you wish to apply for this role, please send your CV with a covering note to oli.dimitrov@advregulatory.com or alternatively, to have a confidential discussion about this or other potential roles or career options, call Oli in the London office on +44 (0)20 7801 3380.

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About Advanced

Advanced Regulatory is a division of Advanced Search and Selection Ltd and has been operating since 2004. We are registered and licensed to recruit through the United Kingdom, mainland Europe and the Americas - we have offices both in the UK and in Switzerland. We are a recruitment business dedicated to the pharmaceutical industry, specialising in Regulatory Affairs.

We match professional candidates to the best permanent, contract and interim roles in the market. For more information about the company visit us at www.advregulatory.com.

We provide a high level of service because we believe this matters. Regulatory professionals will find we know our recruitment subject matter.

Keywords / Key words: Regulatory, Regulatory Affairs, Reg Affairs, RA, Regulatory jobs, RA jobs, Regulatory Affairs Jobs, Regulatory, Regulatory Affairs, Reg Affairs, RA, Regulatory jobs, RA jobs, Regulatory Affairs Jobs, Freelance, Contract, Consultant.

To Apply : Please send a full CV in confidence to cv@advregulatory.com.

Contact Information:

Address:  Head Office
Suite 8 Penhurst House 352-356 Battersea Park Road London
SW11 3BY
England
Tel:  +44 (0)20 7801 3380
Fax:  +44 (0)20 7228 1188
Website:  Visit Our Web Site

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