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Job Details

Associate Director - Marketed Products - Regulatory Affairs

Company: Just Pharma
Reference: OL_RA_AD#2017
Closing Date: 12 Feb 18
Type: Full Time
Salary (£): Competitive

Job Summary:

EXCITING BRAND NEW ROLE working for a reputable global pharma client. My client is looking for an experienced AD in regulatory affairs, within their EU marketed products group. This is a permanent role.


EXCITING BRAND NEW ROLE working for a reputable global pharma client. My client is looking for an experienced AD in regulatory affairs, within their EU marketed products group. This is a permanent role.


Demonstrates leadership and a comprehensive understanding of European RA regulations and guidelines to provide oversight and guidance to address challenges that arise within the assigned projects. Provides a regulatory strategic focus for lifecycle management (variations/amendments, renewals, line extensions/MAAs).
• Oversees and executes all regulatory activities for assigned marketed product(s), including participation in the development of European regulatory strategies for the product lifecycle, from MAAs through to post-marketing (all therapeutic areas, biologics and small molecules).
• Provides European regulatory expertise for new business development opportunities/due diligence.
• Manages direct reports to support scope of project work.


• Leads the regulatory working team and represents team at project team and ensures global regulatory lifecycle management strategy and submission planning are executed according to plan – or oversees if delegated to staff.
• For the project(s)/product(s) of responsibility, collaborates with client lead, as needed, for the authoring of global regulatory strategies and ensures critical deliverables as agreed within the global regulatory strategy and planning.
• Responsible for all DCP, MRP and national submissions and approvals of project(s) of responsibility, or oversees direct reports responsible.
• Responsible for ensuring all other regulatory submissions globally are submitted on schedule by local client affiliates or Marketed Products team within project(s)/products of responsibility by ensuring the regulatory deliverables are provided as outlined in the global regulatory strategy. Interface with regulatory counterparts.
• Executes day-to-day activities for projects or delegates to staff with oversight.
• Identifies regulatory requirements and provides regulatory guidance, and expertise to internal team on the assigned project(s) of responsibility.
• At the request of the client, represents client at Health Authority meetings for project(s)/product(s) of responsibility.
• Evaluates new business development opportunities or participates on due diligence teams, including attendance at bid defences, where requested.
• Identifies and proposes solutions to the management of resource gaps for areas of responsibility.
• Provides oversight to ensure regulatory compliance of marketed products, including oversight of the product-related data in the registration database.
• Line Management of 4 direct reports and 4 external reports


• BSc/BA Degree in a scientific discipline. Preferred advanced degree (MSc/PharmD/PhD).
• A minimum of 6 to 8 years of directly related regulatory European bio/pharmaceutical experience, especially marketed products.
• Solid knowledge of regulations, policies, procedures, drug development guidelines and compliance for European countries.
• Demonstrated track record for successful interactions with European health authorities related post-marketed products.
• Previous line management experience.


key words:

line manager, project manager, manager, director, assocaite director, AD, variations, renewals, MAAs, product lifecycle, regulatory, RA, regulatory affairs

Apply for this job: Associate Director - Marketed Products - Regulatory Affairs

Contact Information:

Address:  Head Office
2nd Floor Albany Chambers, Bridge Road East, Welwyn Garden City, Hertfordshire
Tel:  0044 1707 830300
Website:  Visit Our Web Site

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