Associate Director - Marketed Products - Regulatory Affairs

Recruiter
Just Pharma
Location
London (Greater)
Posted
17 Jan 2018
Closes
18 Feb 2018
Sector
Healthcare
Contract Type
Permanent
Hours
Full Time
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. ROLE DUTIES 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. ACCOUNTABILITIES: • 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 QUALIFICATIONS AND REQUIREMENTS • 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. PLEASE GET IN TOUCH BY CALLING 01707 830301 OR EMAILING OWEN@JUSTPHARMA.CO.UK key words: line manager, project manager, manager, director, assocaite director, AD, variations, renewals, MAAs, product lifecycle, regulatory, RA, regulatory affairs

Similar jobs

Similar jobs