Mary Bolt is recruiting for a Regulatory Affairs Manager to join a global, science-led biopharmaceutical business at their site based in Bedfordshire on a contract basis initially until the end of the year.
The main purpose of the role will be to:
-Deliver and maintain competitive licences for UK/Ireland/Malta, proactively manage the regulatory process and effectively negotiate with regulatory agencies to provide rapid regulatory approvals with competitive labelling as well as preparing high quality regulatory applications and regulatory responses for UK/Ireland/Malta.
-Be responsible for the timely delivery of clinical trial approvals and maintenance of high regulatory compliance standards for UK/Ireland/Malta achieved through provision of local regulatory expertise and proactively manage the regulatory process for clinical trials for UK, Ireland and Malta.
-Defend existing labelling and provide regulatory input into patent defence strategies as well as developing professional working relationships with assessors and administrative staff within the regulatory agencies.
Further responsibilities will include:
-Assuring that appropriate standards and policies for all technical aspects of the company's activities in Regulatory Affairs are adhered to as well as liaising with Operations to manage pack changes and ensure labelling compliance.
-Ensuring appropriate Regulatory Affairs input into the promotional copy approval process, to ensure that core claims and Prescribing Information are in accordance with the licence and provide strategic regulatory advice relating to environmental 'shift' (e.g. POM-P, duplicates, own label supplies, generics, management of black triangle/ symbol).
-Planning and executing workload for the defined product responsibilities and agreeing plan with Regulatory Affairs Lead as well as proactively identifying regulatory strategies to support commercial and business objectives and company efficiencies.
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 sciences or a related field with extensive experience within Regulatory Affairs in the Pharmaceutical industry.
-Experience across the product lifecycle (CTAs/MAAs/maintenance) and experience of driving regulatory strategy.
-Strong communication and demonstrated negotiating skills with the ability to make optimal use of IT systems.
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 CL41257 in all correspondence.
You must be eligible to work in the UK. Learn more
- Agency: CK Group (Science, Clinical, Engineers and IT Recruitment)
- Posted: 14th February 2018
- Expires: 14th March 2018
- Reference: CL41257