Offer summary

Qualifications:

BSc or higher in a life-sciences discipline, Thorough experience in Regulatory Affairs Clinical submissions to the MHRA, Experience in Biologics and CTA processes preferred, Fluency in English and currently based in the UK..

Key responsabilities:

Provide guidance on the RA CTA process linked to the MHRA

Ensure timely completion of key CTA submissions to regulatory standards

Act as the key contact for interactions with the MHRA

Review and amend protocols as needed to support project success.

Job description

For the past 20 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. As the world’s largest RCO (Research Consulting Organization), ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners’ most high-profile drug and device programs.

The Role

ProPharma are currently supporting one of the leading Biological groups globally as they require a SME for their Regulatory Affairs Clinical submission activities in the UK. At present we require an independent freelance/contract Senior Consultant who will work independently and pro-actively to ensure our clients goals are achieved on RA CTA matters. The project offers 1.0 FTE (37.5 hour week); it can be performed fully remotely and will commence immediately with an end date initially of 31st May 2025 but with a great chance of being extended until the 2025.

Essential Functions:

Provide guidance and support on the RA CTA process linked to the MHRA
Ensure key CTA submissions are completed to the correct regulatory standards to all necessary timelines require
Key contact person for interactions with the MHRA for the submission process
Review and amend protocols where needed
Utilise experience to help guide and support the client to ensure the project is an overall success
Ensure you are available and responsiveness to the clients needs while working well with change
Overall support to any other initiatives as and when needed

Experience required

Must be educated to a BSc or higher within a life-sciences discipline
Can demonstrate thorough experience in Regulatory Affairs Clinical submissions to the MHRA
Regulatory Affairs exposure in Biologics is preferred (CTA experience)
Ideally a SME of MHRA requirements linked to CTA’s
Fluency in English is a must
Currently based in the UK
Can perform the role set out in the job spec

#LI-DNI

We celebrate our differences and strive to create a workplace where each person can be their authentic self. We are committed to diversity, equity, and inclusion. Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits. With a holistic approach as an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed.

***ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.***

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