Proclinical is advertising an exciting opportunity for a position as Director of Regulatory Affairs with an international biopharmaceutical company that focuses on identifying, developing, and commercialising meaningful products that address unmet medical needs. This company, which specialises in sleep and haematology/oncology, is seeking for a talent and hard-working individual to join their team in Oxford.
The Director of Regulatory Affairs 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. They will support the company's efforts to obtain worldwide approvals to market our products, along with supporting investigational studies, product registrations, and commercial products. The Director of Regulatory Affairs will manage world-wide interactions and negotiations with regulatory agencies and marketing partners and will act as a key member of project teams responsible for product concept evaluation.
Job Responsibilities:
- Leading functional/department multi-disciplinary teams in complex, business critical projects to establish regulatory strategies for commercial products, late, and early stage development programs.
- Resolving complex strategic issues in creative and effective ways.
- Supervising activities that include planning and coordinating the writing and reviewing of 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.
- Developing and implementing regulatory strategies to facilitate the progress of programs in all phases of development.
- Providing in-depth reviews of Investigator Brochures, IND/IMPDs, reports, reviews of protocols, and all types of regulatory documentation (quality, safety, efficacy, and labelling) including CTAs, anticipating internal and/or external business challenges and/or regulatory issues.
- Serving as the Regulatory affairs representative on project teams or any relevant team, providing direction, solutions, and feedback to the teams.
- Leading regulatory interactions with health authorities, managing document preparation, coordination, rehearsals, and minutes.
- Managing meetings with marketing partners and vendors for their products/projects.
- Supporting the company's commercial products.
- Reviewing and approving labelling for the company's products.
- Ensuring the timely submission of INDs/CTAs/IMPDs, MAAs/NDAs, and variations for their product/projects.
- Maintaining awareness of and communication changing regulatory agency requirements; providing training and regulatory intelligence to the organisation.
- Working with Global Regulatory Leads to support regulatory budget and resource needs for molecule assessing the resource requirement to support molecule strategic objectives.
- Representing the company in external forums.
- Managing junior regulatory professionals.
Skills and Requirements:
- A Bachelors' or Master's, or other advanced degree, in a scientific discipline.
- At least 10 years of regulatory experience, with a proven track record of increasable responsible regulatory experience in the pharmaceutical industry.
- A thorough knowledge of regulatory affairs; direct experience with pharmaceutical regulatory submissions and product approvals.
- A proven track record of effective collaboration with regulatory agencies.
- Demonstrable leadership success in management of regulatory activities.
- Solid experience with regulatory agency interactions and the preparation of documents to support said interactions.
- Detailed knowledge and experience with special consideration opportunities (WW).
- Detailed knowledge of international (WW) regulatory affairs.
- Experienced in preparing Regulatory strategies.
- Experienced with maintaining regulatory authorisations in at least one region.
- Experience with supporting a project with development activities in at least 2 regions.
- Experience with working on early development projects (FIM).
- Evaluative, analytical, and interpretative skills, enabling reviews and synthesis of reports and other documents used in regulatory planning and submissions.
- An ability to work with limited supervision, to set priorities to meet timelines, and to motivate, persuade, and influence others.
- Excellent communication and English skills, in both oral and written capacities.
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 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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