Regulatory Affairs Senior Manager

Proclinical is seeking a dedicated Regional Regulatory Lead to support one or more products from a regional regulatory perspective. As a key member of the Global Regulatory Team, you will be instrumental in developing and executing regional regulatory strategies, managing agency interactions, and ensuring timely regulatory compliance. This role may also involve supervising other regional regulatory leads and support staff.

Responsibilities:

• Advise the Global Regulatory Team on considerations in strategy development for each region.
• Manage submissions for products in compliance with local regulations.
• Lead the expansion of regional regulatory documents and meetings in line with the team's strategy.
• Direct the development of the regional product label in collaboration with the Labelling Working Group.
• Coordinate company responses to requests from authorities.
• Share information and implications with team colleagues on an ongoing basis.
• Perform research to stay updated on new legislation, policies, and technical guidance relating to the products.
• Act as the primary contact and build relationships with agency staff on specific product assignments.
• Manage core activities to ensure effective regional agency interactions.
• Provide managerial leadership & direction to assigned team.

Skills and Requirements:

• Knowledge of regional legislation and experience working with policies, procedures, and SOPs.
• Familiarity with national legislation and regulations relating to medicinal products.
• Understanding of the regional regulatory procedures for clinical trials, marketing authorizations, post-approval changes, extensions, and renewals.
• Strong knowledge of and experience in the regional regulatory environment in the relevant product area and development stage.
• Ability to resolve conflicts and develop a beneficial course of action.
• Cultural awareness and sensitivity to achieve results across both regional country and international borders.

If you are having difficulty in applying or if you have any questions, please contact Peter Duvall at p.duvall@proclinical.com.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology, and medical device companies.

Proclinical Staffing is an equal opportunity employer.