Abbott Regulatory Affairs Manager- Emerging Markets in Maidenhead, United Kingdom
Abbott is a global healthcare leader that helps people live more fully at all stages of life. We create breakthrough products – in diagnostics, medical devices, nutrition and branded generic pharmaceuticals – that help you, your family and your community lead healthier lives, full of unlimited possibilities. Today, 107,000 of us are working to make a lasting impact on health in the more than 160 countries we serve.
The Abbott Established Pharmaceuticals Division (EPD) are looking for a Regulatory Affairs Manager to join their team in Maidenhead.
The Regulatory Affairs Manager is a sole contributor role offering strategic advice for global submissions, particularly for the Emerging Markets. The focus is on policy and strategy implementation and control rather than development and will typically handle short-term operational/tactical responsibilities.
The Regulatory Affairs Manager will be responsible for directing the development of product registration submission, progress reports, supplements, amendments, or periodic experience reports.
Key Responsibilities include:
Interacting with regulatory agencies to expedite approval of pending registration.
Serving as regulatory liaison throughout the product lifecycle.
Participating in some of the following: product plan development and implementation, regulatory strategy, risk management, chemistry manufacturing control (CMC).
Ensuring timely approval of new drugs, biologics or medical devices and continued approval of marketed products.
Serving as a regulatory representative to marketing, research teams and regulatory agencies.
Advising development and/or marketing teams on manufacturing changes, line extensions, technical labelling, appropriate regulations and interpretations.
Required Education and Experience:
Degree educated in a life science subject
Strong experience working with Emerging Markets
As you’d expect from a global healthcare company, we offer a fantastic range of benefits including competitive salaries, a superb defined contribution pension scheme, private healthcare, life assurance and a flexible benefits scheme.
An Equal Opportunity Employer
Abbot welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities.
To request accommodation, please call 224-667-4913 or email email@example.com