Senior Manager Regulatory Affairs

Employer
Barrington James
Location
Germany (DE)
Salary
Starting at €60,000
Start date
17 Nov 2022
Closing date
17 Dec 2022

View more

Discipline
Regulatory Affairs
Hours
Full Time
Contract Type
Permanent
Experience Level
Senior Management
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Job Details

Providing regulatory value assessments/due diligence of in- and outsourcing of marketed products/portfolio or company acquisitions, identifying regulatory opportunities as well as regulatory risks and their potential mitigation:

  • Representing Global Regulatory Affairs in cross-functional pre-due diligence and due diligence teams
  • Providing strategic regulatory input and guidance during evaluation of opportunities in the pre-due diligence and due diligence phase
  • Accountable for an in-depth regulatory assessment of due diligence projects, flagging risks, proposing mitigations, as well as highlighting opportunities

Being responsible for setting the global regulatory strategy for assigned marketed brands to deliver earliest possible approvals with a viable label closely aligned with business’ and patients’ needs, including: 

  • Ensuring alignment and challenging the proper execution of this strategy in collaboration with cross-functional global development and brand teams, including subsidiaries
  • Coordinating the preparation of scientific advice meetings and leads negotiation of global strategies with regulatory health authorities during all stages of the life-cycle, trying to push boundaries wherever possible 
  • Co-defining the strategies for key clinical, preclinical and CMC documents as well as for briefing books, response documents etc., always taking a holistic view on scientific and commercial aspects
  • Understanding the competitive landscape and providing both business intelligence and regulatory expertise in relationship to the indication and compound, analyses trends and their impact.
  • Accountability for leading, developing, facilitating and coordinating the regulatory sub-team driving definition and execution of a global project plan to smartly manage all regulatory activities

What you'll bring to the table

To make the most of this role and truly thrive, you should have:

  • Scientific university degree (Master or PhD) or equivalent in life science pharmacy, biology, chemistry or related discipline)
  • Profound experience in Regulatory Affairs gained in the pharmaceutical industry, a regulatory consultancy, or at a health authority in a global setting (main territorial focus: European Union/US and Latin America, Experience in APAC beneficial), with broad post-marketing experience
  • In-depth knowledge of relevant ICH/EU/US guidelines and regulations covering CMC, clinical and pre-clinical aspects
  • Track record of having delivered competitive regulatory approvals in EU/US and/or Japan
  • Excellent English communication skills, both written and verbal, German and Spanish beneficial
  • Promoting the added value of regulatory affairs for the overall business
  • Flexible, pragmatic, solution-oriented, independent and proactive working style
  • Ability to lead, coordinate and synchronize multiple projects, overcome obstacles and be flexible in changing daily workload priorities

Company

We’re great at what we do. A collection of the worlds finest Life Science recruiters working for the worlds best Life Science consultancy.

Originally, a purely contingency and contract recruiter, focused in the UK, Barrington James is now a sophisticated, highly effective provider of human resources solutions up to full RPO, partnering the pharma, medical devices, and healthcare industries right across the globe.

Find Us
Website
Telephone
01293 776644
Location
Victoria House
Consort Way
Horley
Surrey
RH6 7AF
GB

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