Apply for this job

For more information speak to Tim Barratt on +44 (0)1727 817 626

To apply by email timb.39608.5174@keypeople.aplitrak.com

Apply Now

Regulatory Affairs DirectorRef: BBBH23573

Salary:£90000 - £110000.00 per annum + car allowance, bonus, shares

Added:14 Sep 2018

Region: South East

Sector: Pharmaceutical

Sub Sector: Regulatory Affairs

My client, an international biopharmaceutical company focussing within sleep and haematology/oncology, is currently searching for a Regulatory Affairs Director to join their team based in Oxfordshire. As the Regulatory Director, you will be key stakeholder in the company's regulatory activities and initiatives to ensure the quality of the regulatory input into product development and life cycle management. Essential Functions: *Leads functional/department multi-disciplinary teams in complex, business critical projects to establish regulatory strategies for commercial products, late, and early stage development programs. Resolves complex strategic issues in creative and effective ways. *Supervising activities that include planning and co-ordination of the writing and reviewing all regulatory submissions (INDs, IMPDs, CTAs, MAAs, NDAs, BLAs, meeting requests, and briefing documents). *Develop and implement regulatory strategies to facilitate the progress of programs in all phases of development *Provide in-depth reviews of Review of protocols, Investigator Brochures, IND/IMPDs, reports and all types of regulatory documentation (quality, safety, efficacy and labelling) including CTAs, anticipating internal and/or external business challenges and/or regulatory issues. *Lead regulatory interactions with health authorities *Manage meetings with marketing partners, and vendors for their products/projects *Review and approve labelling for the company's products *Ensure the timely submission of INDs/CTAs/IMPDs, MAAs/NDAs and variations for their products/projects *Work with Global Regulatory Lead to support regulatory budget and resource needs for molecule assessing the resource requirement to support molecule strategic objectives. *Manage junior regulatory professional Required Knowledge and Experience: *Deep and broad knowledge of regulatory affairs; direct experience with pharmaceutical regulatory submissions and product approvals *Demonstrated leadership success in management of regulatory activities *Experience with regulatory agency interactions and preparation of documentation to support interactions *Experience in preparation of Regulatory strategies *Experience with maintenance of regulatory authorizations in at least one region *Experience with supporting a project with development activities in at least two regions *Experience with working on early development projects (FIM) *Ability to work with limited supervision, to set priorities to meet timelines and to motivate and influence others *Excellent verbal and written English and communication skills *Some travel required Required/Preferred Education and Licenses: *Bachelors or Masters or advanced degree in a scientific discipline *Minimum of ten years of regulatory experience with a proven track record of increasingly responsible regulatory experience in the pharmaceutical industry *English language - written and verbal communication skills. For further details about this role, or other opportunities within Regulatory Affairs, please contact Tim Barratt on +44(0)1727 817 626 or email tbarratt@keypeople.co.uk

Apply Now Back To Jobs

We can support your employee requirements

Speak with our support team on 01727 811 634

Contact Us