Hobson Prior are working with an award-winning, data-focused CRO who are looking for an Senior Regulatory Affairs Manager to join them on a permanent basis. This role will allow you to work remotely in the UK.

Please note that to be considered for this role you must have the right to work in this location.

Key Responsibilities:

• You will manage the development of the regional product label to define commercial objectives in the context of available and expected scientific data, regulatory guidance and precedent.
• Manages regional label negotiation activities.
• You will partake in the development and execution of regional regulatory product strategies, including precedence, risk management and contingency planning.
• Consistent with GRT strategy, advise on regulatory implications and requirements related to global clinical development plans and objectives.
• You will plan and manage regulatory submissions for products in compliance with global filing plans and local regulatory requirements. Coordinates with Sponsors and Regulatory Operations Team on the management of large submissions.
• Implements product related regulatory strategies, Regulatory Affairs processes and activity planning in accordance with national legislation and regulatory requirements.
• Leads development of regional regulatory documents and meetings in accordance with global regulatory Team (GRT) strategy.
• Offers regulatory direction on regional regulatory mechanisms to optimize product development.

Requirements:

• Educated degree preferred in related discipline/industry or significant industry experience.
• At least 5 years' experience in pharmaceutical or CRO industry preferred.
• Efficient time management skills; ability to handle multiple work assignments concurrently; ability to coordinate and prioritize conflicting deadlines.
• Strong written and verbal communication skills.
• Knowledge with MS Office, Adobe Acrobat and SharePoint applications.
• Understanding with ISO 9001:2015 and ISO 27001:2013 standards preferred.
• Understanding with 21 CFR Part 11, FDA, and GCP requirements.
• Prior experience in CROs/ Pharmaceutical Services, scientific & clinical data/terminology, and the drug development process a plus.
• Strong organizational skills and extremely detail oriented.

Apply now:

If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" at the top of this page.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.