Regulatory Affairs Directior
CK Group is recruiting for a Regulatory Affairs Directior to join a company in the Pharmaceutical industry at their site based in Cambridge on a contract basis for 12 months and has a daily rate of £700.
The Company: Our client is a global pharmaceutical company with a major presence in the UK. Their purpose is to deliver life-changing medicines and to do this they are completely science-led and like to share this with the scientific, healthcare and business communities within the UK.
The Location: This is an excellent opportunity to be based in our client's offices in Cambridge where you will develop close working relationships with key stakeholders to manage and implement diagnostic testing set-up for clinical trials. Today, Cambridge still remains at the forefront of science and is one of Europe's most important industry clusters. This position comes with the flexibility of up to two days per week working from home.
The Role: As a Regulatory Affairs Director, you will play a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients' lives. In Regulatory Affairs (RA) our teams define the regulatory strategy for our innovative pipeline, influence the development of our therapeutic assets and execute against the health authority engagement and submission plan globally, thereby transforming exciting science into valued new medicines and ensuring patients around the world can access them.
Main Duties and Responsibilities: As the Regulatory Affairs Director:
- You will be accountable for leading the development and implementation of the regional or global regulatory strategy for a product/group of products. You will ensure that the strategy is designed to deliver rapid approval with competitive labeling in keeping with the properties of the product(s) and the needs identified by the business, markets and patients. This includes an health authority engagement strategy and considerations of expedited regulatory programs.
- Will lead a Global Regulatory Strategy Team (GRST) of key contributing members from the regions, emerging markets, RA CMC, Labeling and members of the submission and execution team.
- You will be accountable for the delivery of all regulatory milestones on your team including assessment of the probability of regulatory success based on a thorough assessment of regulatory risks and mitigations. You will lead preparation of the regulatory strategy document and target product labeling.
- You will show strategic leadership skills thereby contributing to effective product development. You will provide team leadership and participate in coaching, and performance feedback to members of your GRST.
- You are accountable for initiating and delivering key regulatory documents and plans and leading the negotiations with health authorities.
- You will lead the objective assessment of emerging data against aspirations and update senior management on project risks/mitigation activities.
- You will be willing to learn from your peers and be actively engaged in peer learning sessions so that the medicines that we develop incorporate the latest approaches in regulatory science. You embrace the concept of novel regulatory tools and technology.
- You will ensure appropriate planning and construction of the global dossier and core prescribing information led by the respective teams. You will be accountable for product maintenance, supply and compliance activities associated with marketed brands.
- You will partner with arketing companies (countries) and regional regulatory affairs staff to influence developing views/guidance.
Your Background: To be considered for this role you must have the following skills/ experience:
- Experience of EU procedures (MAA, variations, PIP, ODD).
- Working with EMA and national EU agencies.
- Experience of oncology and immuno-oncology would be great be not essential.
- Experience of being global regulatory lead on early projects would be great.
For more information or to apply for this position, please contact Jenni on 01438 768 710 email email@example.com. Alternatively, please click on the link below to apply online now. Please note that your CV should show exact dates of employment (month and year) and any gaps of a month or more should be explained.
CK Group is an Equal Opportunities employer and welcomes applications from all who meet our selection criteria.
If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference 46748 in all correspondence.