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

Senior Regulatory Affairs Officer

Company: Regulatory Professionals
Location: Buckinghamshire
Reference: J31015
Closing Date: 20 Dec 17
Type: Full Time
Salary (£): Negotiable
Benefits: up to £50,000 per annum

Job Summary:

Senior Reg Affairs Officer Regulatory Professionals is working with a top 10 UK pharmaceutical company who specialise in the treatment of pain and provide high quality medicines to patients on a global scale.

Requirements:

Senior Reg Affairs Officer
Buckinghamshire, UK
Salary: up to £50,000 per annum
Permanent Position
Job ref: J31015

Regulatory Professionals is working with a top 10 UK pharmaceutical company who specialise in the treatment of pain and provide high quality medicines to patients on a global scale.

Job Responsibilities will include, but are not limited to:
* Preparation of documentation for EU licences (new MAAs, variations and renewals)
* Conducting post approval changes within EU markets
* Involvement in life cycle management and ensuring submissions meet Regulatory requirements
* Compile documentation for new EU registrations according to CTD requirements
* Preparation of MAAs, CTAs, ethical committee applications, labelling texts and leaflets

The ideal candidate will possess the following skill set:
* Bachelor's degree in Pharmacy, Chemistry or Life Sciences
* A minimum of 6 years Regulatory experience
* In-depth knowledge of EU Regulatory procedures
* Knowledge of CTD dossier writing (in particular modules 1 to 3)
* Experience in preparation of modules for eCTD format
* Proven experience of variations, renewals, new licence application submissions using National Procedures
Alternatively, if you know someone that may be interested in this role then please feel free to pass this advertisement on and if they are successfully placed then you'll receive £250 worth of vouchers of your choice.

Regulatory, NP, Clinical Trials, Market Authorisation, CTD, licence variations, licence renewals, High Wycombe, Buckinghamshire Regulatory Affairs Senior Officer, Permanent, Life cycle management, LCM, MAA, Marketing Authorisations, clinical development, Hertfordshire, Buckinghamshire, London, Luton, EU, CP, DCP, MRP, National Procedures, United Kingdom, England, Berkshire, Essex, Middlesex

Apply for this job: Senior Regulatory Affairs Officer

Contact Information:

Address:  UK Office
3rd floor 33 Blagrave Street Reading
RG1 1LG
England
Tel:  +44 (0)118 9522 797
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.