Regulatory Affairs Director - Marketed Products
ProClinical is partnering with an international biopharmaceutical company to advertise a vacancy for a Director, Regulatory Affairs position, joining the team in their Oxford-based office.
The Director, Regulatory Affairs will be a key stakeholder in the company's regulatory activities and initiatives to oversee regulatory activities of product development and life cycle management for licensed products. They will support the company's efforts to obtain and maintain global agreements with Health Authorities to market their products. The Director, Regulatory Affairs will manage worldwide interactions and negotiations with regulatory agencies, internal stakeholders, and partners in support of product registrations and continuity of supply. They will be a key member and may lead project teams while also overseeing junior regulatory team members.
- Managing partnerships from regulatory standpoint for products/projects.
- Supporting the company's commercial products.
- Reviewing and approve labelling for the company's products.
- Reviewing documentation in support of commercial products (i.e., clinical protocols/CSRs, investigatory brochures, quality, nonclinical, and safety).
- Ensuring the timely preparation, reviews, and submission of investigational and product submissions, such as INDs/CTAs/IMPDs, MAAs/NDAs/BLAs, and variations for product/projects.
- Overseeing direct reports in preparation and management of above responsibilities and assisting as needed.
Skills and Requirements:
- A Bachelor or Masters (and/or other advanced degree) in a scientific discipline.
- A proven track record of increasingly responsible regulatory experience in the pharmaceutical and/or biotech industry.
- A deep and broad knowledge of regulatory affairs and requirements.
- Direct experience with biological and/or pharmaceutical regulatory submissions and product approvals.
- A proven track record of effective collaboration with regulatory agencies.
- Demonstrable success in management of regulatory activities.
- Demonstrable experience with regulatory agencies and preparation of documentation to support interactions.
- An ability to lead agency interactions.
- Demonstrable experience in preparation of investigational and new product submissions with EU, US, and ex-US countries including eCTD format.
- Demonstrable experience in preparing global regulatory strategies.
- Demonstrable experience with maintenance of regulatory authorisations and variations in at least two regions.
- Demonstrable experience with supporting a project with development activities in at least two regions.
- Demonstrable experience working on cross functional teams.
- Strong evaluative, analytical, and interpretative skills enabling review and synthesis of reports and other documents used in regulatory planning and submissions.
- Capability of working with limited supervision, to set priorities to meet timelines, and to motivate and influence others.
- Solid experience managing and mentoring junior regulatory professionals.
- Excellent interpersonal skills, including communication, presentation, persuasion, and leadership.
- Excellent business English, orally and in writing.
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 Alex Czuprynski on + 44 203 869 2329 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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