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

Regulatory Affairs Associate Director **Belgium*** Would you like to work on Biotech projects in a Global Role…???

Company: Advanced Regulatory (UK & Europe)
Location: BELGIUM with Relo
Reference: TMADV / 210517D
Closing Date: 23 Nov 17
Type: Full Time
Salary (£): On Application
Benefits: On Application

Job Summary:

If you wish to apply for this role, please send your CV with a covering note to cv@advregulatory.com or alternatively, to have a confidential discussion about this or other potential roles or career options, call Theo Moore or Matt Greig in the London office on +44 (0)20 7801 3380.

Requirements:

Regulatory Affairs Associate Director  **Belgium*** Would you like to work on Biotech projects in a Global Role…???

Join a leading Biotechnology company with fantastic pipeline, offering great projects, full project autonomy, fantastic promotion prospects, and the opportunity to grow into a Global RA liaison with strategic responsibility for development and registration

As the EU regulatory representative on the appropriate development / commercialisation / lifecycle project or product team you will lead and implement regulatory strategies in agreement with key stakeholders for assigned projects/products and in line with EU commercial goals.

Duties:

  1. Accountable for ensuring EU contribution to Global Regulatory Strategies and implementation plans (including core labels, risk registers) developed for assigned project/s.
  2. Ensures regulatory contributions achieve the objectives in the strategy, achieve agreed standards, minimise resource demands whilst maximising overall project delivery time and probability of success and facilitating post filing activities.
  3. Partners with project teams and other customer groups (e.g. RU/BU Stakeholders Country Regulatory Managers and EU Brand Teams) to ensure required regulatory contributions (line plans, CTA, MAA, variations, license renewals etc) meet business needs and are provided to the project teams, to agreed time, cost and quality standards.
  4. Ensures regulatory plans are monitored, progress/variance communicated to Senior Management and any risks (from emerging technical data, changing internal objectives or external threats) mitigated
  5. Ensures an aligned EU regulatory position is reached and communicated for all key issues for assigned project/s, and that these regulatory positions supporting the EU business are championed and communicated.
  6. Works closely with other Regulatory Product managers within, and across, sites to ensure consistent, and appropriate processes, systems, working practices, shared learning’s and quality standards.
  7. Implements systems, processes and procedures relating to regulatory strategy productivity improvements, ensuring that these facilitate the sharing of information across the relevant lines.
  8. Engages in appropriate activities in order to influence the regulatory environment through Agency contacts and Trade Associations as appropriate.
  9. Ensures business compliance and implementation of and adherence to Regulatory standards.
  10. Develops and maintains constructive working relationship with Health Authority contacts.

Experience:

  • Proven examples of delivery across the Drug, Discovery, Development and commercialisation lifecycle, with demonstrable contribution in Regulatory Affairs.
  • 8-12 years regulatory affairs experience
  • Proven ability to manage complex regulatory issues.
  • Proven ability to consistently deliver to time, cost and quality standards.
  • EU regulatory experience including knowledge of CTA’s and MAA submission processes.

______________________________________________________________________________________________

If you wish to apply for this role, please send your CV with a covering note to cv@advregulatory.com or alternatively, to have a confidential discussion about this or other potential roles or career options, call Theo Moore or Matt Greig in the London office on +44 (0)20 7801 3380.
______________________________________________________________________________________________

About Advanced

Advanced Regulatory is a division of Advanced Search and Selection Ltd and has been operating since 2004. We are registered and licensed to recruit through the United Kingdom, mainland Europe and the Americas - we have offices both in the UK and in Switzerland. We are a recruitment business dedicated to the pharmaceutical industry, specialising in Regulatory Affairs.

We match professional candidates to the best permanent, contract and interim roles in the market. For more information about the company visit us at www.advregulatory.com.

We provide a high level of service because we believe this matters. Regulatory professionals will find we know our recruitment subject matter.

Keywords / Key words: Regulatory, Regulatory Affairs, Reg Affairs, RA, Regulatory jobs, RA jobs, Regulatory Affairs Jobs.

To Apply : Please send a full CV in confidence to cv@advregulatory.com.

Contact Information:

Address:  Head Office
Suite 8 Penhurst House 352-356 Battersea Park Road London
SW11 3BY
England
Tel:  +44 (0)20 7801 3380
Fax:  +44 (0)20 7228 1188
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.