Regulatory Affairs Manager
An internationally known biotechnology company has an opening for a Regulatory Affairs Manager job at their office in Maidenhead, UK. The company has a strong reputation for developing innovative therapies for neurological diseases and employs approximately 7,000 people worldwide.Job Role and Responsibilities:
- Responsible for developing and implementing innovative global regulatory strategies for product development and approval
- Responsible for defining strategies for meeting and keeping post-approval compliance
- Responsible for regulatory documents, submissions, and compliance issues
- Represent the company with contractors and corporate partners
- Provide regulatory support for various departments, projects, and teams/committees
- Might manage direct reports
- Responsible for the successful development and implementation of regulatory strategies for new registration submissions including post-approval compliance for assigned portfolio in region
- Provide strategic guidance and regulatory leadership at project team meetings as well as represent the Global Emerging Markets strategy for assigned products in region
- Identify and assess regulatory risks associated with the execution of regulatory strategies in assigned region
- Define strategies to mitigate risks
- Keep abreast of changes in regional legislation
- Responsible for coordinating the preparation of the regulatory submissions including responses to questions from the Health Authorities
- Lead preparation and represent the company at Health Authority meetings
- Highlight key issues that may impact the execution of regulatory strategy across territories
- Build and maintain effective relationships with both internal as well as external stake holders
- Prepare and deliver effective presentations for external and internal audience
- Demonstrate strong organizational skills, including the ability to prioritize personal and any direct reports workload
- Strong interpersonal skills and the ability to deal effectively with a variety of personnel including medical, drug safety, scientific, and manufacturing staff
- Minimum 6-8 years pharmaceutical/biotechnology industry experience (including 5 years + of Regulatory Affairs experience).
- BA/BS/University degree required, Life/Health Sciences preferred.
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 Peter Duvall on 0203 0789 542 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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