Regulatory Affairs Specialist

TalentMark is recruiting for a Regulatory Affairs Specialist to join a company in the Pharmaceutical industry, at their site based in Reading, on a contract basis initially for 4 to 6 months.

Salary:

£50.75 per hour PAYE or £68.89 per hour Umbrella (inside IR35)

Regulatory Affairs Specialist Role:

• Ensures the success of new product registrations, line extensions and new indications and claims in alignment with the business plan.
• Manages the coordination, compilation, submission of new drug applications, cosmetics, medical devices, and food supplements.
• Assesses the acceptability of quality, preclinical and clinical documentation for submission filing.
• Monitors the progress of the regulatory authority review process through appropriate communication with the Health Authority.

• Hold a relevant scientific degree or have equivalent working experience.
• Experience with local UK/IE affiliates,

  Direct engagement with

  authority

  MHRA and HPRA.

• knowledge of OTC medicines, plus experience with post-approval activities for both safety & CMC.
• Exposure to PAGB is a plus.
• Extensive experience in regulatory affairs in pharma, consumer health, or similar.

Our client is the largest and most broadly-based healthcare company. They strive to improve access and affordability, create healthier communities, and put a healthy mind, body and environment within reach of everyone, everywhere.

Location:

This role can be remote based in the UK, preference for 2 days per week onsite in Reading.

Apply:

It is essential that applicants hold entitlement to work in the UK. Please quote job reference 174 868 .

Please note:

This role may be subject to a satisfactory basic Disclosure and Barring Service (DBS) check.

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