ProClinical have a new vacancy at a pharmaceutical company working in research and development of highly effective and innovative medications. This job vacancy is for a Senior Regulatory Affairs to join their team at their Cambridge offices. The company is one of the industry's most well-known brands and specialises in R&D in 3 major areas; respiratory, oncology and inflammation.
- Provide overall leadership and regulatory strategic oversight in Europe for the company's portfolio.
- Lead the development of EU Regulatory Strategy for the Consumer Health portfolio and ensure optimal development and execution of regulatory plans for approval and commercialisation of company products in line with business goals.
- Ensure optimal regulatory life cycle management of the company's EU Consumer health portfolio.
- Partner with the Consumer Health business to aggressively pursue opportunities for growth and portfolio expansion in Europe and beyond.
- Provide input to global regulatory/commercialisation strategy for Consumer Products and play a leadership role in enhancing strategic regulatory capabilities for Consumer Health products across the company's network.
- Provide extensive, up-to-date regulatory expertise on current development and marketing authorisation requirements and procedures to develop innovative strategies that drive faster (to market) product development, regulatory approval and launch penetration across the European company network for the company portfolio.
- Establish a focused and entrepreneurial strategic regulatory approach for Consumer Product development that is compliant with EU Regulatory guidelines and enables the company to differentiate its portfolio commercially.
- Advise internal company stakeholders including Senior R&D and Commercial Management, cross-functional drug development teams and representatives at our Independent Associated Companies (IACs) on the interpretation of emerging regulatory and scientific guidelines or regulatory processes and their impact on company product development plans for Consumer Health products.
- Lead and execute product development life cycle management strategies including new indications/geographic expansions for existing products to maximise portfolio value.
- Coordinate and participate in new drug acquisitions/co-development as well as other business development activities, providing critical regulatory assessment and recommendations to enable the company decision making process.
- Establish strong relationships with co-development partners to ensure delivery and effective execution of regulatory strategies in line with the company's and Alliance partner interests.
- Develop the company's capabilities in obtaining, disseminating and leveraging Regulatory Affairs and Consumer Health business intelligence in a way that will confer strategic advantage to the company's network of companies in the development and commercialisation of its Consumer Health product portfolio.
- Advise regulatory leadership on formulating internal and external public company position and policy on Consumer Health regulatory matters and ensure optimal regulatory advocacy efforts on behalf of the company.
Skills and Requirements:
- A proven Consumer Health/OTC regulatory strategist and thought leader with a successful track record of ensuring EU/global development and registration of high value Consumer Health product assets across multiple therapeutic areas.
- Advanced degree e.g. MSc, PhD, Pharm D or MD in a relevant scientific discipline with a minimum of 10 years of experience in Regulatory Affairs, Drug Development or a related discipline, including at least 5 years leading, developing and executing EU/Global Consumer Health regulatory strategy in multiple therapy areas.
- Substantial strategic regulatory mindset coupled with commercial-nous and track record of delivering commercial advantage and business impact through innovative regulatory approaches in the Consumer Health care space. Is able to demonstrate ability to impact organisations approach to drug development and influence and drive change.
- Established credibility with regulatory agencies with excellent negotiation skills and demonstrable success in influencing HA positions to ensure positive regulatory outcomes. Track record of overseeing quality regulatory submissions and approvals across EU and other territories. Experience in delivering superior Consumer Health regulatory outcomes in Emerging Markets desirable.
- Strong leadership skills with both practical and short/long term strategic vision; ability to build relationships and inspire confidence and respect at all levels; excellent team player.
- Outstanding communication skills; ability to build rapport and demonstrate strong influencing and negotiation skills; excellent listening ability - receptive to feedback and demonstrates flexibility, curiosity and an ability to learn.
- Ability to attract and nurture talent and to create and foster a team culture of excellence in an open and rewarding environment which promotes diversity and inclusion
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 +44 203 0789 542 or upload your resume 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.