Distinguished Scientist, Regulatory Affairs Europe Therapeutic Area Lead, General Medicine - United Kingdom
- Our company is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products.
- Today, we are building a new kind of healthcare company – one that is ready to help create a healthier future for all of us.
- Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of an individual like you.
- To this end, we strive to create an environment of mutual respect, encouragement and teamwork.
- As part of our global team, you’ll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.
- Act as a team leader on the General Medicine Therapeutic Area, Europe.
- Manage a team of regulatory liaisons / associate liaisons and provide advice and support to teams cross-functionally/cross-divisionally on the projects.
- Define, develop, and ensure execution of innovative regulatory strategies for development and registration of the products in scope.
- Ensure high quality regulatory submissions, including original marketing authorization applications, post-approval variations, scientific advice briefing documents, and PIPs.
- Optimize the life-cycle management of all products in the therapeutic area and ensure regulatory compliance for the assigned products in the region.
- Contribute to the development of the portfolio in close collaboration with key stakeholders internally in the subsidiaries and regional / global teams, as well as externally with the Regulatory Agencies for the projects assigned.
- Take ownership of new projects in this context; projects may be complex, broad in scope, with multiple indications or formulations, and may involve external business partners.
- Monitor, prioritize and supervise projects’ strategy, time lines, and milestones in compliance with applicable regulation, and ensure effective communication to / engagement from stakeholders.
- M.D., Pharm.D. or Ph.D. in life science, complemented with 6+ years of relevant experience is required.
- A M.Sc. degree with substantial additional experience (6+ years) or a B.Sc. with an additional 8+ years experience in regulatory affairs or related discipline could suggest an equivalent ability to function in this position.
- Excellent interpersonal, written and verbal communication skills both internal and with regulatory health authorities.
- In this position strong people management skills are a pre-requisite.
- Demonstrates the ability to translate deep knowledge and experience in the global/regional/local regulatory landscape to advise on and drive company’s cross-functional regulatory strategy.
- Viewed as a subject matter expert related to regulatory/risk communications and submissions, and advises on effective data and presentation approaches.
- Able to effectively influence and negotiate with regulatory agencies related to company’s submissions, clinical risk management and pharmacovigilance strategies to achieve positive regulatory outcomes.
- Applies extensive knowledge of the disease and therapeutic environment to advise on global development strategies for a disease or therapeutic area and establishes relationships with external scientific advisers on behalf of R&D.
- Viewed as a subject matter expert by internal and external stakeholders related to emerging trends/innovations and treatment best practices specific to a disease and therapeutic area.
- Applies extensive knowledge of translational medicine to make strategic go/no-go decisions related to disease area studies.
- Our employees are the key to our company’s success.
- We demonstrate our commitment to our employees by offering a competitive and valuable rewards program.
- Our Company’s benefits are designed to support the wide range of goals, needs and lifestyles of our employees, and many of the people that matter the most in their lives.