At a Glance
- Tasks: Manage regulatory submissions and ensure compliance for generic medicines.
- Company: Established generics pharmaceutical company with a focus on quality and employee growth.
- Benefits: Hybrid working, career development, and a supportive team environment.
- Other info: Fast-paced environment with opportunities for ongoing training and development.
- Why this job: Join a dynamic team and make a real impact in the pharmaceutical industry.
- Qualifications: Degree in Life Sciences or Pharmacy and proven Regulatory Affairs experience.
The predicted salary is between 49500 - 60500 £ per year.
An established, research-driven generics pharmaceutical company with a strong presence across the UK and EU markets. The organisation offers a collaborative, team-oriented environment and is committed to delivering high-quality, affordable medicines while supporting employee development.
As a Senior Regulatory Affairs Associate, you will support the lifecycle management of a diverse portfolio of generic medicinal products. You will be responsible for preparing and submitting regulatory dossiers (including MAAs, variations, and renewals) in line with MHRA and EMA requirements, as well as managing post-approval activities.
You will liaise with regulatory authorities, respond to queries within agreed timelines, and ensure compliance of product labelling and documentation (SmPCs, PILs, artwork). The role also involves supporting regulatory strategy, tracking submission timelines, and monitoring evolving regulatory guidelines to assess business impact.
What you'll need to succeed:
- Degree in Life Sciences, Pharmacy, or a related field
- Proven Regulatory Affairs experience within the pharmaceutical industry (generics preferred)
- Strong knowledge of UK (MHRA) and EU regulatory frameworks
- Experience with CTD/eCTD submissions and lifecycle management
- Familiarity with variations and post-approval processes
- Excellent organisational and communication skills
- Ability to manage multiple projects in a fast-paced environment
What you'll get in return:
- Hybrid working (3 days onsite in London, 2 days remote)
- Opportunity to work within a collaborative and supportive team
- Exposure to a broad and varied generics portfolio across UK and EU markets
- Career development and ongoing training opportunities
If you're interested in this role, click 'apply now' to forward an up-to-date copy of your CV.
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