Senior Director, Global Regulatory Affairs CMC Biologics – Top 10 Pharmaceutical company - Waterford with remote working - €negotiable, car allowance, 20% bonus, 10% pension, healthcare, 25days holiday + BH
The Senior Director, Global Regulatory Affairs CMC Biologics is responsible for managing a small team whilst remaining hands on. You will lead the Regulatory aspects of Chemistry, Manufacturing and Controls (CMC) for licensed and clinical biological products in development.
This is an exciting time to join highly successful, top 10 global pharmaceutical, company based in Waterford (with remote working). Covering multiple therapy areas, they have an impressive product portfolio spanning over 90 established products.
- Top 10 Pharmaceutical company
- Cover multiple therapy areas across over 90 products
- Operate on a global basis and have 4 areas of their business – pharma, consumer health, vaccines and biotech
The Senior Director, Global Regulatory Affairs CMC Biologics will be responsible for;
- Leading the Regulatory aspects of Chemistry, Manufacturing and Controls (CMC) for licensed and clinical biological products in development
- Provide senior strategic leadership in new applications for products, CTAs, Licence maintenance and post marketing activities
- Manage a small team of Regulatory Managers / Associates
- Develop regulatory strategies for new MAAs and product lifecycle maintenance activities
To apply for this role as a Senior Director, Global Regulatory Affairs CMC Biologics our client is hoping for someone with the following skills and experience;
- Good regulatory affairs experience within a pharmaceutical company, specifically within CMC and /or Biologics
- Excellent knowledge / experience of EMA and FDA
- Previous management experience
- Excellent clinical trial regulatory experience
- Life Science degree is preferred
What should you do next?
This Senior Director, Global Regulatory Affairs CMC Biologics role is one not to be missed; it encompasses the opportunity to work in a well-established, global consumer healthcare business who are at the forefront of their market. If you are interested in this role or want to hear about any other Regulatory Affairs jobs, please get in touch.
Unless otherwise stated, if applying for a job within the UK or European Union, you must ensure that you are already authorised to work there.
Carrot Pharma Recruitment Ltd acts as an Employment Business and an Employment Agency on behalf of our client in recruitment for this role.