Regulatory Affairs Associate Director – Global Pharma – West London with remote working - £competitive basic salary, bonus, pension, healthcare
This is an excellent opportunity to work for a global, market-leading pharmaceutical company based in West London. You will define and deliver EU and Global regulatory strategies for projects, particularly focussing on early development up to clinical proof of concept (PoC).
This is an exciting time to join a highly successful, well established, global pharmaceutical company based in West London.
- Global, well established pharmaceutical company
- Global company but have a small family feel to their UK affiliate.
- Excellent career progression opportunities
- Invest in training and development.
- Excellent flexible working options
This is a global role whereby you will work closely with senior stakeholders/counterparts across multiple territories. You’ll define and deliver complex regulatory strategies across multiple regions.
- Define and deliver EU or Global regulatory strategies for projects, particularly focussing on early development up to clinical proof of concept (PoC).
- Providing regulatory intelligence and market updates to the wider business
- Support and lead development and implementation of a global regulatory strategy, including Target Product Profile, Target Labelling, Key Claims Document and Clinical Development Plan.
- Lead planning, preparation and submission of regulatory submissions for EU (and any other responsible countries/territories) e.g. Clinical Trials Authorisations, Orphan Drug Designations, Paediatric Investigations Plans.
- Lead communications with EU Health Authorities, including scientific advice meetings with EMA and/or EU Competent Authorities
- Oversee delivery of Global regulatory strategy and operational plans through leadership in particular to ensure achievement of key regulatory goals and timelines with regard to fast, efficient and innovative drug development programmes
To apply for this role as Regulatory Affairs Associate Director our client is hoping for someone with the following skills and experience;
- Ample Regulatory Affairs experience ideally covering both the EU and Globally
- Good management experience
- Strong stakeholder management experience
- Pharma or CRO experience
What should you do next?
This Regulatory Affairs Associate Director role is one not to be missed; it encompasses the opportunity to work in a market-leading pharmaceutical company that has an excellent, steady pipeline. To discuss this Regulatory Affairs Associate Director role further or to find out about other Regulatory Affairs jobs I’m currently working on, please get in touch or hit apply to submit your current CV.
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.