Associate Director Regulatory Affairs
|Job Title:||Associate Director Regulatory Affairs|
|Contact Name:||Alastair McCartney|
|Job Published:||August 03, 2017 09:39|
- As Associate Director Regulatory Affairs, you'll collaborate to define, develop and lead global and/or regional strategies to maximize regulatory success.
- You'll effectively communicate objective assessments of the likelihood of success of these regulatory strategies. Provides strategic and tactical advice and guidance to teams to achieve timely and efficient conduct of development programs and/or oversight of marketed product support, while maintaining full compliance with applicable regulatory requirements.
- Provide regulatory expertise for multiple projects or one complex development project and / or marketed product(s) of responsibility.
- Manage and trains direct reports and / or mentors team members, if required, to support scope of project work.
- May be called upon to act as deputy to the Global Regulatory Lead, therapeutic area head and/ or Region regulatory head, and/or Marketed Products Head, attending internal leadership team meetings, as appropriate.
QUALIFICATIONS / EXPERIENCE REQUIRED:
- To achieve the objectives of Associate Director Regulatory Affairs you'll need the following background:
- BSc degree or equivalent in science; advanced degree preferred.
- Considerable pharmaceutical industry experience. This is inclusive of thorough regulatory experience or a solid combination of regulatory and/or related experience in both development and /or post-marketing phases.
- Solid working knowledge of regulations and guidance's governing drugs and biologics in all phases of development, including post-marketing, in the EU.
- Understands and interprets complex scientific issues across multiple projects as it relates to regulatory requirements and strategy.
- Preferred experience in managing major regulatory filing(s); and significant contributor to regulatory and/or development strategies.
Before you apply for this position it is vital that you are in possession of an EU or UK passport or relevant visa to work without restrictions in the UK.
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