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

Pharmiweb.com RSS Feed Pharmiweb.com RSS Feeds

Pharmiweb.com RSS Feed PharmiWeb Candidate Blog

Pharmiweb.com RSS Feed PharmiWeb Client Blog

Job Details

Regulatory Manager, OTC

Company: Key People Limited
Location: Essex
Reference: 1609-61
Closing Date: 08 Dec 16
Type: Permanent
Salary (£): 40,000 - 60,000
Benefits: bonus and benefits

Job Summary:

An exciting opportunity has arisen for an experienced Regulatory Affairs Manager to join one of the world's largest Pharmaceutical companies within their global OTC Regulatory team. You will be mainly focusing on new submissions on a global scale.

Requirements:

An exciting opportunity has arisen for an experienced Regulatory Affairs Manager to join one of the world’s largest Pharmaceutical companies within their global OTC Regulatory team. You will be mainly focusing on new submissions on a global scale.

Within this role you will work as a Regulatory Manager in the central OTC Regulatory Affairs department, specifically working with OTC medicinal products. The success of the OTC team has been outstanding to date and will continue to flourish in the near future due to ambitious project plans for 2017.
Skills & Experience:

- To be considered for this role you will be educated to BSc (Hons) level (or equivalent)
- Significant experience within OTC Regulatory Affairs.
- Experience in the registration of OTC (human medicinal) products in the EU and international markets will be required to be considered for this role.

Main Responsibilities:

- Lead the registration process for new Marketing Authorization Applications
- Manage new MAAs submitted via DCP, MRP or Nationally
- Assist the OTC Associate Director for New Submissions in development of registration strategies.
- Ensure that dossiers are compiled and dispatched in accordance with work plan commitments and internal KPIs
- Develop and maintain thorough and up-to-date understanding of the European and other regions regulatory environment: provide early input to multi-functional team on new initiatives and plans
- Close interaction with other functions across R&D to gain early visibility of dossier content, identify risks and propose corrective actions
- Actively work on launch critical post-approval variations for authorised products until project is transferred to Central Maintenance & Compliance Team
- Provide central RA support to countries and regions

For further details about this role, or for a confidential discussion about other vacancies within Regulatory Affairs, please contact Tim Barratt on +44(0)1727 817 626 or email tbarratt@keypeople.co.uk

Apply for this job: Regulatory Manager, OTC

Contact Information:

Address:  Head Office
Catherine House
Adelaide Street
St Albans
Hertfordshire
AL3 5BA
England
Tel:  Tel: 44 (0) 1727 811634
Fax:  Fax: 44 (0) 1727 844838
Website:  Visit Our Web Site

Advertising
Share | | |
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.