CK Group are recruiting for a Regulatory Affairs Senior Manager to join a company in the Pharmaceutical industry at their site based in Cambridge or Uxbridge on a contract basis for 6 months initially.
Our client is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.
Located less than an hour away from London by train, the role will be based in Cambridge, one of Britain's most beautiful cities. Set in the Cambridgeshire countryside, the city is home to 31 university colleges, some of them dating back to the twelfth century.
Our client first established a presence on the Cambridge Science Park more than 25 years ago. Today, Cambridge still remains at the forefront of science and is one of Europe's most important biotechnology clusters.
This role will provide regional regulatory support for one or more products. As a member of the Global Regulatory Team (GRT), the incumbent will be accountable for developing and executing regional regulatory strategies across the product lifecycle and managing effective agency interactions. The individual should have a proven track record supporting the diversity of regulatory procedures in the EU (inc. PIPs, variations, IMPDs, MAAs) and ability to work autonomously.
• Define and advise the GRT on regional considerations in developing creative regulatory strategy
• Ensure European regional needs are well defined and implemented in collaboration with relevant regional stakeholders
• Develop and implement regulatory strategy and executional plans, and manage regulatory submissions (e.g. clinical trial and marketing applications) for assigned products in accordance with global filing plans, core labelling documents and regulatory requirements
• Lead development of regional regulatory documents and meetings, and provide regulatory advice on regional regulatory requirements, mechanisms to optimize product development and to maintain compliance
• Co-ordinate and provide guidance to company responses to requests from regulatory authorities, e.g Response to Questions (RTQs)
• Communicate and ensure alignment with proposed regulatory strategies such that expectations, regulatory risks and mitigations are characterised and understood.
• Estimate the likelihood of regulatory success and timelines based on proposed strategies; discuss with GRT and line Management, and communicates to stakeholders
• Maintain an awareness of new and developing legislation, regulatory policy and technical Regulatory guidance relating to Amgen products, and evaluates and communicates impact
• Act as contact and create relationships with agency staff on specific product assignment and document and communicate details and outcomes of regulatory agency interactions
To be successful in this role you should have the following skills, knowledge and experience:
• Demonstrable experience acting as therapeutic area European Regulatory Affairs lead, defining and implement regulatory strategies and executional plans
• Practical Regulatory knowledge of regional legislation
• Working with policies, procedures and SOPs
• Experience with national legislation and regulations relating to medicinal products
• Understanding of the regional regulatory procedures for CTAs, MAs, post approval changes, extensions and renewals
• Understanding of drug development
• Strong knowledge of and experience in regional regulatory environment in relevant product area and development stage
• Comprehensive understanding of regulatory activities, touch points and how they affect projects and processes
• Ability to resolve conflicts and develop a course of action leading to a beneficial outcome
• Cultural awareness and sensitivity to achieve results across both regional country and International borders
• Experience in Oncology and working with biotechnology products would be preferable but is not essential
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 KA42901 in all correspondence.
You must be eligible to work in the UK. Learn more
- Agency: CK Group (Science, Clinical, Engineers and IT Recruitment)
- Contact: Lucy Stendall
- Phone: 01246 457733
- Reference: KA42901
- Posted: 25th July 2018
- Expires: 22nd August 2018