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ragupathyrenganathan
Required – Regulatory Affairs Manager (UK) – Permanent Hertfordshire!
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Job Details

Regulatory Affairs Manager (UK) – Permanent Hertfordshire

Company: DOCS Global
Location: Watford
Reference: AS-014243
Closing Date: 09 Nov 15
Type: Permanent
Salary (£): 40,000 – 60,000
Benefits: 15% bonus, pension, Health and dental cover

Logo: DOCS Global

Job Summary:

Office based RA Manager urgently required for Hertfordshire based Pharma with a significant presence in the branded generics markets.

Requirements:

Role Responsibilities

1.     Successfully interact with the project and functional teams in India to ensure that data generated is appropriate and will be presented and compiled in accordance with EU requirements.

2.     Oversight of Regulatory Tracking Database. Liaise with contract services provider to ensure that the Regulatory Tracking Database is able to provide relevant and timely information on pending and approved products.

3.     Manage the submission process (generally DCP, MRP, CP or national submissions) including responses to requests for further information from Competent Authorities, managing the national phase for MA issue following closure of the European Regulatory Procedures.

4.     Post-approval activities including maintenance of approved MAs and launch activities.

5.     Assistance in compilation of compliance files for new licence approvals and updating compliance files during life cycle of the product where necessary.

6.     Liaise with external companies with respect to in-licensing and out-licensing activities and any associated regulatory issues as required.

KNOWLEDGE, SKILLS AND ABILITIES

Education 

  • A degree in pharmacy or a related scientific subject
  • Membership of TOPRA and ideally experience in EGA

Experience

  • A minimum of 4 years of relevant regulatory affairs, ideally in a generics environment.
  • Knowledge and Skills (Functional / Technical)
  • Experience of de-centralized procedure and mutual recognition procedure is required
  • Some centralized procedure experience would be an advantage
  • Submissions of ECTD procedure submissions would be an advantage

Leadership / Managerial Attributes

  • Good self-discipline and attention to detail.
  • Good time management and organization skills.
  • Good written and verbal communication skills.
  • Good team working skills, able to influence in order to achieve objectives.
  • Other attributes: self-motivated, creative thinking, ambitious and hard-working, hands-on approach, high level of intelligence, computer-literate, foreign languages are an advantage.

WHAT IS OFFERED

  • Permanent
  • Competitive salary + 15% bonus, pension, Health and dental cover

To apply for this job,  copy & paste  the link below

http://www.pharmiweb.com/careers/frm_application.asp?ROW_ID=794628



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