An excellent opportunity has arisen for an experienced Regulatory Consultant, with a strong background in RoW and European strategy. The main focus of this role with be within post approval, but a candidate with development exposure would be preferable.
*You will participate a member of a multi-disciplinary team to establish regulatory strategies. Identify and communicate potential risks associated with regulatory strategy scenarios
*Support the preparation, review and submission of regulatory submissions, (i.e.: including marketing applications, clinical trial applications, amendments, variations, responses to Agency questions, meeting requests, briefing packages, annual reports, periodic safety reports).
*Coordinate the 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
*Provide in-depth reviews of protocols, reports, presentations and documents
*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
*Regulatory experience in the pharmaceutical and/or biotech industry
*Experience with HA and/or EMA regulatory procedures ie: 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 Masters or advanced degree in a scientific discipline
For further details on this role, or other vacancies within Regulatory Affairs, please contact Tim Barratt on +44(0)1727 817 626 or email email@example.com.