Senior Manager - Global Regulatory Affairs CMC Biologics – Top 10 Pharmaceutical company - Remote working in the EU with occasional travel to Ireland - £negotiable, car allowance, bonus, 10% pension, healthcare, 25days holiday + BH
The Senior Manager, Global Regulatory Affairs CMC Biologics is responsible for managing a small team whilst remaining hands on. You will manage the regulatory activities associated with the Chemistry, Manufacturing and Controls for licensed and clinical biologic products.
This is an exciting time to join highly successful, top 10 global pharmaceutical, company based in Ireland (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 Manager, Global Regulatory Affairs CMC Biologics will be responsible for;
- Developing innovative regulatory strategy and assuring this regulatory strategy is aligned with relevant legislation
- Provide strategic input into new applications for products, CTAs, Licence maintenance and post marketing activities
- Manage a small team of Regulatory CMC professionals
- Develop regulatory strategies for new MAAs and product lifecycle maintenance activities
To apply for this role as a Senior Manager, 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 Manager, 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.