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Regulatory Affairs Manager - Emerging Markets - 4 positions available

Salary

Competitive

Location

Central London

Job Type

Full Time

Reference No: RI3349077632

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Job Description

Based in Central London with some home working flexibility, this position would be ideal for candidates with strong non-EU region experience, candidates with strong EU experience would also be considered as long as they have had a small amount of non-EU region experience also.

Role Responsibilities

  • Undertaking International Regulatory strategies for product lifecycle, including product development and post-marketing all therapeutic areas, biologics (30%) and small molecules (70%). To work cross-functionally within Regulatory, as well as with Commercial, Global Marketing, Clinical Development and so forth to identify what international regulatory requirements are necessary and how to best move forward to meet project plans.
  • Ensures implementation of the strategy to ensure proper facilitation and preparation of International regulatory documents and various submissions, as well as any compliance matters 
  • To successfully communicate with international Health Authorities
  • Executes the Regulatory submissions to support product development and approval efforts for all post-market products in non-US and non-EU countries (such as focusing on the emerging markets; Asia Pacific, Latin America, Russia, India, etc. but also including other developed countries such as Australia, S. Africa).
  • Responsible for staying current with revised regulations/guidance for impact on product development plans in order to propose and implement appropriate changes.  

 

For further information please get in touch with Natalie Hopkins; 02071 835 059 - natalie@linkfieldgroup.com

Applicant Requirements
  • Degree in a scientific discipline. Preferred advanced degree (MS/PharmD/PhD)
  • Regulatory international bio/pharmaceutical experience
  • Solid knowledge of regulations, policies, procedures, drug development guidelines and compliance for all emerging and selected developed markets
  • Excellent written and oral communication skills required
  • Knowledge of eCTD
Reference No: RI3349077632
Linkfield Life Sciences are a Regulatory Affairs Recruitment Partner, working with organisations across the Life Sciences sector.

Hiring Manager(s)

Natalie

Head of Regulatory Affairs Recruitment at Linkfield Life Sciences
email: natalie@linkfieldgroup.com

Email Natalie

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