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Regulatory Associate Labelling Manager

4 months ago

Hatfield, United Kingdom Hays Specialist Recruitment Limited Full time

Associate Labelling Manager
An opportunity to play an important part of a global healthcare company who deliver access to medicines, progress sustainable operations and develop innovative solutions, empowering people around the world to live healthier at every phase of their life.
About the Company:
Your new company has delivered high-quality medicines to patients in more than 165 countries and territories. Their portfolio includes over 1,400 approved molecules across a wide range of therapeutic areas, spanning both non-communicable and infectious diseases,including globally recognized brands, complex generic and branded medicines, and a range of over-the-counter consumer products.
Your New Role As the Associate to Labelling Hub manager you'll be responsible for:

- Regulatory activities relevant to labelling updates for determined countries according to internal procedure and legislation applied.
- You will also play a key role influencing operations, providing Subject Matter Expert support to Labelling Hub manager and other Stakeholders, with initiatives which may impact labelling activities regarding the set region and countries.
- Make sure local labelling text is prepared correctly first time and on-time according to agreed company procedures and objectives.
- Make sure that supportive documents, not limited to Core Data Sheet or other Reference Label such as USPI, SmPC are acquired in a well-timed manner to the countries according to local legislation
- Organises and updates Local Labelling texts above market on behalf of all impacted markets to guarantee their compliance with internal procedures and local legislation.
- General knowledge of preparing artwork from labelling text and the interface with Launch Management, Supply Chain and Quality teams.
- Ensures maintenance of relevant systems according to relevant SOPs.
- Ensures compliance with all relevant company SOPs
- Provide support during Medical and Regulatory Audits and any other duties as assigned.

What you need to Succeed:

- 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

What you'll get in return:

- Competitive salary
- Attractive benefits
- Career Growth
- 2 day/month hybrid-working

What you need to do now