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Regulatory Affairs - Project Manager

Job Title: Regulatory Affairs - Project Manager
Contract Type: Contract
Location: Hertfordshire, England
Industry:
Salary: Competitive
Start Date: 2018-10-18
Reference: BH-91830-1
Contact Name: Syeda Islam
Contact Email: syeda.islam@nesgt.com
Job Published: October 19, 2018 15:59

Job Description

Regulatory Affairs Market Authorisation Project Manager – Hertfordshire – Contract – 12 Months

Regulatory Affairs Market Authorisation Project Manager Essential
: Regulatory Affairs. Market Authorisation. Regulatory strategies and maintenance. Product legislation. Immediately available.
Regulatory Affairs is a key component within the pharmaceutical product life cycle. Within that market authorisation plays a key role in ensuring all relevant licences are in place to make the product available across the market in various regions. To support this function, my client, a world renowned pharmaceutical company is looking hire regulatory affairs personnel to join their evolving regulatory team.

Regulatory Affairs Market Authorisation Project Key Responsibilities
:
  • Responsible for tasks associated with market authorisation for Ireland and UK
  • Primary contact with regulatory authorities regarding product licences and maintenance activities
  • Notify relevant bodies of all safety and quality issues, ensuring they are being dealt with and expedited where necessary
  • Ensure all product information contained within SPCs and PILs are compliant for market authorisation
  • Ensure all SPCs and PILs are accessible to healthcare professionals via compendia
  • Respond to all regulatory related quires ensuring the information is aligned to agreed strategy
  • Complete and review Market Authorisation Holder (MAH) periodically
  • Coordinate meetings with regulatory agencies playing a key role in the overall outcome
  • Effective planning of regulatory activities with clearly outlined timeline
  • Take a proactive lead displaying leadership and providing suitable solutions to all queries
Regulatory Affairs Market Authorisation Project Key Requirements:
  • Life sciences graduate with extensive experience within regulatory affairs for the pharmaceutical industry
  • In-depth understanding of all aspects of regulatory affairs for the UK and Ireland
  • Sound knowledge of drug development and overall product life cycle
  • Proven project management skills demonstrating leadership and ownership of outcome
  • Knowledge and experience troubleshooting commercial and medical issues
  • Awareness of competitor product and activities
  • Good interpersonal and influencing skills
  • In depth understanding of regulatory governance
There are two positions available for this is role on a 12 month contract basis. Candidates must be immediately available and be eligible to work in the UK. If successful you can expect a competitive salary package as well as the opportunity to join a world leader in global pharma.

Please contact Syeda Afsana Islam on 0161 942 4060 for more information on rates and applying.

Regulatory Affairs Market Authorisation Project Manager – Hertfordshire – Contract – 12 Months