Mary Bolt at CK Clinical is recruiting for a Senior Manager Regulatory Affairs - Neurology to join a global pharmaceutical company committed to contributing to better healthcare at their site based in Hertfordshire on a permanent basis.
Our client is a global Pharmaceutical company who place patients and their families at the forefront of everything they do.
The role is based at our client's site in Hertfordshire which is commutable from many towns from Middlesex to Cambridgeshire. There are good road and public transport networks and London is easily reachable. Hertfordshire boasts many landmarks as well as beautiful countryside.
The main purpose of the role will be to:
-Act as the EU Regulatory Lead for early phase products, input to global regulatory strategy, including design of clinical development programmes and lead the preparation of orphan drug applications, PIPs and clinical trial applications.
-Develop and implement regulatory strategy for own functional area and region and lead issue resolution of regulatory risks by identifying, escalating and monitoring issues as well as contributing to the planning, execution, and assessment of product life cycle management activities and strategies.
-Organise resources and processes across multiple teams / functions to develop and deliver complete regulatory submissions within agreed timeframes and provide regulatory support to project teams for allocated projects.
Further responsibilities will include:
-Contributing to and implementing strategy for interactions and negotiations with health authorities and autonomously handling routine communications with regulatory authorities.
-Providing feedback, setting clear tasks and objectives and coaching team members on a periodic basis and training team members on processes and / or systems as well as managing contractors and ensuring that contractors, consultants and vendors complete assigned work according to agreed timelines.
-Complying with all applicable laws / regulations of each country in which they do business and reporting legal, compliance and ethical violations in a timely manner.
In order to be considered for this role, you will be required to have the following qualifications, skills and experience:
-Educated to degree level or above in life science or a related field with signifcant experience of working within Regulatory Affairs at a senior level.
-Familiarity with EU Regulatory procedures including clinical trials, scientific advice, PIPs and orphan drugs as well as Regulatory strategy experience, strong strategic thinking skills and experience of liaising and negotiating with regulatory authorities, both verbally and in writing.
-Excellent written and verbal communication skills, strong problem solving skills and eye for detail, must be able to operate in a complex environment and adapt well to changes.
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 CL42806 in all correspondence.
You must be eligible to work in the UK. Learn more
- Agency: CK Group (Science, Clinical, Engineers and IT Recruitment)
- Contact: Mary Bolt
- Phone: 01438 743047
- Reference: CL42806
- Posted: 30th July 2018
- Expires: 27th August 2018