Healthcare Compliance and Medical Director

1 day ago

Witney, Oxfordshire, United Kingdom Abbott Laboratories Full time

{"h1": "Senior Regulatory Manager, Clinical Affairs", "p": "At Abbott, we are passionate about improving the quality of people's lives through innovative healthcare solutions. As a Senior Regulatory Manager, Clinical Affairs, you will play a critical role in ensuring the development and manufacture of our products meet required legislation and regulations.

Your key responsibilities will include:

* Identifying and implementing new regulatory policies, processes, and SOPs
* Evaluating regulatory risks of corporate policies
* Providing strategic guidance for product development and planning throughout the product lifecycle
* Analyzing and comparing regulatory outcomes with initial product concepts and recommending future strategies and actions
* Developing global regulatory strategies and updating based upon regulatory changes
* Conducting regulatory due diligence for potential and new acquisitions and advising management
* Utilizing technical regulatory skills to propose strategies on complex issues
* Leading crisis management program development and implementation
* Recruiting, developing, and managing regulatory professionals
* Approving regulatory filing strategies based upon proposed preclinical, clinical, and manufacturing changes
* Reviewing and approving labeling to ensure compliance
* Representing regulatory affairs in product recall and recall communication process
* Providing strategic input and technical guidance on regulatory authority queries
* Overseeing processes involved with maintaining annual licenses, registrations, listings, and patent information
* Negotiating internally and externally with regulatory agencies and participating in political lobbying
* Creating project plans and timelines
* Leading functional groups in the development of relevant data to complete a regulatory submission
* Developing and communicating a vision for the organizational unit assigned
* Providing technical leadership to business units
* Administering/meeting regulatory requirements to achieve excellent compliance status with no enforcement actions
* Negotiating with regulatory authorities during the development and review process to ensure submission approval
* Writing and editing technical documents
* Evaluating performance of and assisting in career development planning for subordinates ", "h2": "Requirements", "ul": [{"li": "Bachelor's Degree (Science, Math, or medical fields preferred)"}, {"li": "Master's Degree (Technical area or MBA is preferred)"}], "p": "At Abbott, we offer a comprehensive benefits package, including health and wellness programs, financial benefits, and a competitive salary. We are an equal opportunities employer and welcome applications from diverse candidates.

If you are a motivated and experienced regulatory professional looking to join a dynamic team, please submit your application.

#J-18808-Ljbffr"}

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