Pharmiweb ChannelsAll | PharmaCo | Clinical Research | R&D/BioTech | Sales/Mktg | Healthcare | Recruitment | Pharmacy | Medical Comms

Pharmiweb.com RSS Feed Pharmiweb.com RSS Feeds

Job Details

Associate Director - Marketed Products - Regulatory Affairs

Company: Just Pharma
Location:
Reference: OL_RA_AD#2017
Closing Date: 17 Dec 17
Type: Full Time
Salary (£): Competitive
Benefits:

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.

Requirements:

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

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
AL7 1HL
England
Tel:  0044 1707 830300
Website:  Visit Our Web Site

Advertising
Site Map | Privacy & Security | Cookies | Terms and Conditions

PharmiWeb.com is Europe's leading industry-sponsored portal for the Pharmaceutical sector, providing the latest jobs, news, features and events listings.
The information provided on PharmiWeb.com is designed to support, not replace, the relationship that exists between a patient/site visitor and his/her physician.