Regulatory Affairs Director
ProClinical is working with an international biopharmaceutical company that is seeking a Regulatory Affairs Director to be based in Oxford on a contract basis. Director, Regulatory Affairs at the company will be a 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. He/she will support the company's efforts to obtain worldwide approvals to market our products. The Director, Regulatory Affairs will manage worldwide interactions and negotiations with regulatory agencies and marketing partners in support of investigational studies, product registrations, and commercial products. The Director, Regulatory Affairs will be a key member of project teams and teams responsible for evaluation of product concepts.
- 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). Ensuring that the internal review and submission of these items has been appropriately managed.
- 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.
- Serve as the Regulatory Affairs representative on project teams or any relevant team; assure the progress of projects by providing direction, solutions and feedback to the teams
- Lead regulatory interactions with health authorities, manage document preparation, coordination rehearsals and minutes
- Manage meetings with marketing partners, and vendors for their products/projects
- Support the company's commercial products
- 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
- Maintain awareness of and communicate changing regulatory agency requirements; provide training and regulatory intelligence to the organization
- Work with Global Regulatory Lead to support regulatory budget and resource needs for molecule assessing the resource requirement to support molecule strategic objectives.
- Represent the company in external forum
- Manage junior regulatory professional
Skills and Requirements:
- Deep and broad knowledge of regulatory affairs; direct experience with pharmaceutical regulatory submissions and product approvals
- Proven track record of effective collaboration with regulatory agencies
- Demonstrated leadership success in management of regulatory activities
- Experience with regulatory agency interactions and preparation of documentation to support interactions
- Possibly leader in agency interactions
- Knowledge of and possibly experience of special consideration opportunities WW
- Knowledge of international (WW) regulatory affairs (demonstrated by above)
- 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)
- Evaluative, analytical and interpretative skills enabling review and synthesis of reports and other documents used in regulatory planning and submissions
- 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
- 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.
- Responsibilities may require working outside of "normal" hours, in order to meet business demands.
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 David Nixon on +44 203 078 9544 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.
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