An attractive job opportunity has arisen at a leading multinational pharmaceutical company. They are seeking a Regulatory Consultant to work at their UK site in Middlesex. The company employs 100,000 personnel across 150 countries, working across multiple therapy areas including cardiovascular, oncology, and respiratory.
Responsible for the regulatory management of marketing authorisations (MAs) for a therapy area and is the primary interface with the regulatory authorities.
- Proactive leadership in defining and implementing effective regulatory strategy, influencing as needed to reflect business needs.
- Responsible for assigned non-product activities of significance to the department /company. These may be of a complex nature.
- Responsible for the regulatory management of MAs for a therapy area /portfolio, for Ireland and UK
- Is the primary interface with the regulatory authorities on product licensing and MA maintanence activities.
- Ensure product information is compliant with MA. Ensures that company product Summary of Product Characteristics (SPCs) and Patient Information Leaflets (PILs)/ labeling are compliant with MA and with regulatory requirements
- Ensures that the current SPC and PILs are available to Healthcare Professionals on electronic compendia in UK and Ireland
- Co-ordinates national input into responses to regulatory questions and regulatory commitments, ensuring these are in alignment with regulatory requirements and agreed strategy and timelines.
- Responsible for the local management of product registration documents in regulatory databases and repositories.
- Manage regulatory agency correspondence in accordance with company procedures
- Notify to Regulatory agencies product quality and safety issues in an expeditious manner in accordance with company procedures
- Effective planning of regulatory activities for therapy area
- Provides considered regulatory advice, leadership and expertise to brand teams and to other regulatory and cross functional groups.
- Co-ordinates meetings with regulatory authorities and plays a key role in these interactions
- Builds and maintains effective relationships with internal regulatory, commercial, supply chain and clinical groups.
- Takes a proactive lead and shows an ability to focus and identify key issues early and contribute fully to the development of solutions
- Graduate/PhD level or equivalent in, with experience in the pharmaceutical industry, including regulatory experience. Area of specialisation: Life Sciences
- In depth understanding and practical experience of national or/and EU regulations, guidelines and working practices and of the regulatory issues relevant to the portfolio.
- Knowledge of drug development process and regulatory affairs,
- Knowledge of the commercial and medical issues pertaining to the assigned portfolio, including an awareness of competitor products and activities
- Ability to work in a complex environment
- Good interpersonal and influencing skills
- Has an understanding of the impact of the regulatory environment and proposed changes which are likely to impact the business in the medium term.
- Can define regulatory strategy
- Has an in-depth understanding of regulatory governance, medical and safety
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 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.