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Labelling Regulatory Affairs Coordinator

Employer
Achieva Group Ltd
Location
United Kingdom
Salary
Not specified
Start date
8 Aug 2022
Closing date
7 Sep 2022

View more

Discipline
Regulatory Affairs, Labelling
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)
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Job Details

 

Overall Job Purpose:
 
The Labelling Regulatory Affairs Analyst is responsible for regulatory activities pertaining to labelling updates for determined country/ies according to internal procedure and legislation applied to country/ies under her/his responsibility.
 
 
Main Accountabilities:
 

 

  • Point of Contact to Global Labelling Team regarding countries/licenses under her/his responsibility
  • Ensure that supportive documents, not limited to Core Data Sheet or other Reference Label such as USPI, SmPC are timely dispatched to the countries according to local legislation
  • Provide support to all submissions that require labelling information, such as new products, Line Extensions, variations including HA query management.
  • Arranges and updates Local Labelling texts above market on behalf of all impacted markets to ensure their conformity with internal procedures and local legislation.
  • Ensures maintenance of relevant systems according to relevant SOPs.
  • Ensures compliance with all relevant company SOPs
  • Provide support during Medical and Regulatory Audits.

 

 
Basic Qualifications

We are looking for professionals with these required skills to achieve our goals:

 

  • Bachelor's degree in Science, Medicine or Pharmacy, or another related field
  • Labelling and Regulatory experience
  • Regulatory experience working with Regional Heath Authorities and in-depth Regional Labelling knowledge
  • Highly developed interpersonal, presentation and communication skills with advanced English language capability

 

Preferred Qualifications

If you have the following characteristics, it would be a plus:

 

  • Master's Degree, PharmD, or PhD in Science, Medicine, or Pharmacy.
  • Ability to provide innovative approaches/recommendations to product labelling that meet corporate goals while maintaining compliance with relevant laws and regulations.
  • Understand GLC requirements/ processes and EU/ US regulatory requirements.
  • The ability to influence effectively in a matrixed, cross functional team environment

Company

ACHIEVA is an experienced head on new shoulders. 

ACHIEVA comprises five respected specialist recruitment businesses*1, joining forces to become one stronger and more powerful entity, bolstered by research, development and environmental enterprises that share our core values.

We have over three decades of experience in sourcing industry experts across a wide range of specialist sectors including Pharmaceuticals, Primary Care, Occupational Health, Health & Safety, Engineering, Development and Research.

Businesses are people powered. Now more than ever, they want resourceful, motivated and dynamic individuals who have the ability to thrive during times of change as well as the ability to weather any storm. ACHIEVA will find these people and will place them in environments where they will flourish.

ACHIEVA is born out of a recognition that the workplace is evolving and that with change, comes great opportunity. Opportunity for our clients and for our candidates.

ACHIEVA. It’s in the name.

Find Us
Website
Telephone
01727 811634
Location
Second Floor
Blenheim Gate
22-24 Upper Marlborough Rd
St Albans
Hertfordshire
AL1 3UU
GB
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