Regulatory Affairs Role Dublin

Global Regulatory Affairs Manager

  • Posted Apr 16, 2021
  • Dublin
  • Contract
  • VAC-19085

LSC have a great contract opportunity for a Global Regulatory Affairs Manager to join a biopharmaceutical company in Dublin focused on serving patients with severe and ultra-rare disorders through the innovation, development and commercialization of life-transforming therapeutic products.

If you have 5 years in pharmaceutical industry regulatory affairs and are ready for your next challenge, this could be the perfect project for you!

ABOUT THE PROJECT - KEY RESPONSIBILITIES:
o Works with manager, global and local regulatory leads to develop and direct innovative and effective regulatory strategies in support of assigned marketed portfolio in the EU.
o Provides advice on regulatory issues for marketed products; actively collaborates with management and cross functional colleagues (i.e., commercial, research, clinical development, medical affairs, business development, legal, manufacturing, quality, portfolio management, financial, human resources, etc.).
o Work with Global Labeling Lead and Global Regulatory Lead on assigned EU label updates to marketed products
o Prepares and executes post marketing activities for EU: RMP management, renewals and annual reports, and labeling variations
o Prepares and executes aspects of regional (mainly EU) regulatory affairs and ensures integration into global regulatory strategy.

ABOUT YOU - ARE YOUR SKILLS A MATCH?
o Pharmacist or equivalent education in a life science (biology, chemistry, etc.)
o Strong knowledge of drug development and regulatory policy in EU region (other regions is a plus); excellent scientific and business judgment.
o Ability to manage complex issues and coordinate multiple projects simultaneously
o Highly conversant and knowledgeable of new and emerging regulations and guidance. Understanding of GMPs, GLPs and GCPs; solid understanding of where to seek and how to interpret regulatory information.

Note: Are you currently eligible to work in Ireland? As this is a contract opportunity you will need to hold a Stamp 1G/Stamp 4 visa to apply!

Apply via this advert or contact Katie Brown at LSC on 021-4777329 if you have anymore questions about this Global Regulatory Affairs Manager opportunity!

This could be the perfect project for you! Submit your CV below and we’ll be in contact shortly

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The benefits of contracting with LSC

  • Partners to the world’s top Life Science companies we offer you the best contract opportunities in the industry
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  • LSC’s Consultant Success Programme focuses on skills development & on-site support to help you achieve your career goals!

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