Associate Director, Regulatory Affairs
ProClinical is advertising a vacancy for an Associate Director, Regulatory Affairs position with a leading biopharmaceutical company. Proud of its achievements, which include a solid portfolio of life-saving drugs built on its extensive scientific research, this company is seeking an exceptional individual to fill the vacancy and join their team in Cambridge.
- Leading all regulatory activities for assigned projects and territories in line with company and regional requirements, along with scientific and company policies & procedures.
- Managing a team of Regulatory professionals.
- Submitting or ensuring submission of all regulatory documents required to obtain and maintain clinical trial applications and marketing authorisations for assigned products and territories.
- Preparing and/or managing other submissions that are technically complex and require extensive interaction with departments outside of Regulatory Affairs.
- Ensuring regional product labelling following the Company Core Data Sheets (CCDS) and Company Core Safety Information (CCSI) and ensuring that any updates to the CCDS or CCSI are implemented in a timely manner.
- Ensuring product packaging and associated information is updated and maintained in accordance with the marketing authorisation.
- Acting as the regulatory project team representative for specified products.
- Representing Regulatory function at internal meetings.
- Participating in industry trade group and regulatory affairs professional societies where applicable.
- Maintaining knowledge of complex regulatory requirements, contributing to the preparation of new regulatory guidance wherever possible, commenting on draft regulatory guidance, and communicating changes in regulatory information to project teams and senior management.
- Initiating or contributing to local and/or global process improvements which have a significant impact on the business.
Skills and Requirements:
- At least a Bachelor's degree in a relevant discipline, though an advanced degree is desirable.
- Direct experience working with Regulatory Authorities in assigned territories.
- Demonstrable people management experience.
- Demonstrable experience representing Regulatory Affairs on project teams.
- Excellent interpersonal skills, including oral and written communication, influencing, and negotiation.
- Excellent organisational skills, including delegation, scheduling, and managing.
- An extensive knowledge of regulatory requirements, at both company and regional requirements for assigned territories; furthermore, an understanding of global and regional trends in Regulatory Affairs and an ability to assess the impact of these requirements to the business.
- Demonstrable experience in developing and implementing regulatory strategy and of managing complex negotiations with Regulatory Authorities.
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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