Senior Core Labelling Strategy Manager
2 weeks ago
We are currently looking for a Senior Core Labelling Strategy Manager to join a leading Pharmaceutical company based in the Hertfordshire area.
KEY DUTIES AND RESPONSIBILITIES:
Your duties as the Senior Core Labelling Strategy Manager will be varied however the key duties and responsibilities are as follows:
1. Manage the preparation, review and approval of the labelling documentation, for example; CCDS and USPIs.
2. Make new partnership of labelling leads with project leads and regulatory matrix to ensure efficient and effective labelling development.
3. Work closely with the Risk and Safety team to make sure to content of the labelling is verified and agreed. IF this cant happen then reach out to the Global Labelling Committee (GLC) for guidance and recommendations.
4. Carry out internal influences that manage the team to work more efficiently and also involved with external activities such as trade associations and FDA events.
ROLE REQUIREMENTS:
1. Relevant degree in a Science or Pharmacy related field.
2. Proven industry experience in pharmaceutical labelling environment.
3. A working knowledge and practical experience with EU and US regulatory requirements.
Key Words: RA, Regulatory Affairs, Labelling, GLC, Labelling Strategy
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