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Regulatory Affairs Officer

Job title: Regulatory Affairs Officer
Contract Type: Permanent
Location: Ifield, England
Industry:
Salary: £40000 per annum
Reference: BH-93719
Contact Name: Ellen Twomey
Phone Number: 01
Job Published: 16 days ago

Job Description



REGULATORY AFFAIRS OFFICER

CRAWLEY

£35,000 - £40,000

 

This rapidly growing Pharmaceutical client are looking for a Regulatorey Affairs officer to join their expanding team to maintain all UK product licenses, Import license and Wholesaler Dealer License in accordance with UK regulatory guidelines (MHRA) and to ensure all UK license applications are submitted in accordance with Torrent Pharma UK company requirements.

 

KEY ROLES AND RESPONSIBILITIES

 

• To ensure that the company’s products comply with the regulations of the Medicines and Healthcare Regulatory Agency (MHRA)

• To ensure the company’s manufacturer (MIA) and wholesale dealer (WDL) licenses are maintained and up to date to allow importation and distribution of all company’s products

• To support the Torrent Group’s regulatory department for eCTD submissions

• To prepare submissions of license variations and renewals to strict deadlines

• To respond to questions from regulatory authorities raised during technical review of submissions, variations and renewals

• To write and review all SOP’s within the regulatory department

• To keep abreast of all European regulatory legislation, guidelines and customer practices

• To keep up to date with the company’s current and future product range

• To interface all regulatory affairs with the in QA function of the company

• Monitoring and setting timelines for license variations and renewal approvals by reporting to the General Manager on an agreed format and frequency 

• To write clear, accessible product labels and patient information leaflets

• To manage the user testing of patient information leaflets when required

• To specify storage, labelling and packaging requirements in accordance with the product licences

• To undertake and manage all regulatory inspections

• To support regulatory affairs aspects for project management of new product development and launches

• To manage electronic interface (RAMA portal) with the MHRA for license maintenance.

• To manage payments and accounts with the MHRA for all UK company regulatory activity

• To undertake ad hoc duties on behalf of the General Manager as and when required

• To comply with the office policies and guidelines

 

KNOWLEDGE & EXPERIENCE REQUIRED PERSONAL SKILLS REQUIRED

 

• Experience with communicating with the MHRA at an administrative and strategic level

• Understanding of European regulatory guidelines, regulations and procedures

• Knowledge of other European Market Authorisation bodies, eg. IMB

• Knowledge of GMP and GDP

• Knowledge of MHRA fees

• Understanding of the timescales of the approval processes within the MHRA

• Understanding the company Reg Affairs SOP’s

• Understanding of pharmacovigilance practices and procedures

• Understanding of the drug development process

• Excellent communication skills

•Strong interpersonal skills

•Accurate

Please apply ASAP for immediate consideration!

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