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!

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.

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!

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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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