Senior Regulatory Manager, Clinical Affairs

1 month ago

Witney Oxfordshire, United Kingdom ABBOTT Full time

Abbott is about the power of health. For more than 135 years, Abbott has been helping people reach their potential - because better health allows people and communities to achieve more. With a diverse, global network serving customers in more than 160 countries, we create new solutions - across the spectrum of health, around the world, for all stages of life. Whether it's next-generation diagnostics, life-changing devices, science-based nutrition, or novel reformulations, more than 113,000 of us are working together in advancing some of the most innovative and revolutionary technologies in healthcare, helping people live their best lives through better health. At Abbott, you can help shape the future of healthcare whilst shaping your career.

As the Industry Leader, Abbott Diabetes Care designs, develops and manufactures glucose monitoring systems for use in both home and hospital settings. We have a Centre of Excellence in Witney for the development and manufacture of electrodes and biosensors used by patients and healthcare professionals for the day-to-day management of diabetes. The site, and its Statistics team, has been instrumental in the research, development and manufacture of the FreeStyle Libre Flash Glucose Monitoring System and continues to work on a strong pipeline of products in development. We are passionate about doing work that improves the quality of people's lives. Joining us, you can do work that truly matters.

We currently have an exciting opportunity to join us as Senior Regulatory Manager, Clinical Affairs.

The function of a Senior Regulatory Affairs Manager is to combine knowledge of scientific, regulatory and business issues to enable products that are developed, manufactured or distributed to meet required legislation.

MAIN RESPONSIBILITIES

  • Identify need for new regulatory policies, processes and SOPs and approve them.
  • Evaluate regulatory risks of corporate policies.
  • Provide strategic guidance for product development and planning throughout the product lifecycle.
  • Analyse and compare regulatory outcomes with initial product concepts and recommend future strategies and actions.
  • Develop global regulatory strategies and update based upon regulatory changes.
  • Conduct regulatory due diligence for potential and new acquisitions and advise management.
  • Utilize technical regulatory skills to propose strategies on complex issues.
  • Lead crisis management program development and implementation.
  • Recruit, develop and manage regulatory professionals.
  • Approve regulatory filing strategies based upon proposed preclinical, clinical and manufacturing charges.
  • Review and approve labelling to ensure compliance.
  • Represent regulatory affairs in product recall and recall communication process.
  • Provide strategic input and technical guidance on regulatory authority queries.
  • Oversee processes involved with maintaining annual licenses, registrations, listings and patent information.
  • Negotiate internally and externally with regulatory agencies and participate in political lobbying.
  • Create project plans and timelines.
  • Lead functional groups in the development of relevant data to complete a regulatory submission.
  • Develop and communicate a vision for the organizational unit assigned.
  • Provide technical leadership to business units.
  • Administer/meet regulatory requirements to achieve excellent compliance status with no enforcement actions.
  • Negotiate with regulatory authorities during the development during the development and review process to ensure submission approval.
  • Write and edit technical documents.
  • Evaluate performance of and assists in career development planning for subordinates.
Education:

  • Bachelor's Degree (Science, Math or medical fields preferred)
  • Master's Degree (Technical area or MBA is preferred)
Abbott has health/wellness and financial benefits that help provide security for you and your family. As you'd expect from an innovative global health care company, we offer excellent salaries and a competitive range of benefits including a defined-contribution pension scheme, share ownership scheme, private healthcare, life assurance, and a flexible benefits scheme. Here at Witney, we also like to help our employees live life to the fullest, and therefore we offer a range of optional initiatives for you to get involved in, including onsite allotments, couch to 5k campaigns, bee keeping, yoga and more#J-18808-Ljbffr

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