Global Regulatory Strategy Manager

Proclinical is working with an international biopharmaceutical company that is seeking a Global Regulatory Strategy Manager to be based in Oxfordshire on a contract basis. The Manager will be responsible for supporting the regulatory team on post-marketing authorization life-cycle activities and may support process improvement and development activities of non-marketed products. He/she may also support the company's efforts to obtain worldwide approvals to market our products. As Manager within the Global Regulatory Affairs Strategy Department will be a key member of project teams.

Job Responsibilities:

• Participate as an active member of a multi-disciplinary team to establish regulatory strategies. Identify and communicate potential risks associated with strategy scenarios
• Support the preparation, review, and submission of regulatory submissions as appropriate, (i.e.: including marketing applications, clinical trial applications, amendments, variations, responses to Agency questions, meeting requests, briefing packages, annual reports, periodic safety reports). Coordinate preparation and review of responses to Agency questions.
• Manage communication to Health Authorities and internal stakeholders verbally and written
• Ensure consistency/completeness/accuracy, and adherence to regulations and applicable guidelines for regulatory submissions
• Manage review tracking systems for regulatory documents and promotional materials
• Enter data into Regulatory Database
• Provide in-depth reviews of protocols, reports, presentations and documents
• Manage timelines to ensure approvals are timely and development objectives are met
• Review and interpret recent product approvals, current regulatory guidance documents, and recent public Advisory Committee proceedings to support regulatory strategy and submissions
• Provide risk assessments and recommendations for various regulatory scenarios
• Participate in the electronic review and quality verification of regulatory submissions

Skills and Requirements:

• Regulatory experience in the pharmaceutical and/or biotech industry
• Experience with HA and/or EMA regulatory procedures i.e.: Regulatory Submissions.
• Demonstrated understanding and strategic application of regulations and guidelines for drug development
• Excellent English verbal and written communication skills
• Ability to work within a team environment or individually with limited supervision, attention to detail, set priorities to meet timelines and to motivate and influence others
• Exceptional interpersonal skills with the ability to work with individually or within a multi-disciplinary team with external partners and regulators
• Some international travel may be required
• Bachelors or master's or advanced degree in a scientific discipline

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Peter Duvall on +44 203 0789 542 or upload your CV on our website - www.Proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.