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*Senior Associate Regulatory Affairs - Cambridge or Uxbridge - Leading Biotech*!
Location: Hybrid in Cambridge or Uxbridge - TBC FTE: Full time Start date: ASAP Planet Pharma are working with a leading biotechnology company focused on discovering, developing, manufacturing, and delivering innovative human therapeutics.
The company specializes in using advanced science and biotechnology to address serious illnesses, particularly in areas like oncology, cardiology, immunology, and nephrology .
Role Overview : We are looking to hire a regulatory professional who is passionate about science and our portfolio, capable of supporting the regulatory team and contributing to our mission to serve patients.
What You Will Do: In this critical role, you will be assigned to one or more products and may support a Regional Regulatory Lead (RRL) or manage a program under the supervision of an experienced regulatory lead.
Implement the regional regulatory strategy and execute regulatory plans.
Prepare supporting documentation for regulatory submissions, including clinical trial applications, marketing authorizations, and lifecycle management activities.
Utilize internal systems and document management tools.
Ensure compliance with regulatory requirements for assigned products.
Work with internal policies and standard operating procedures (SOPs).
Foster effective communication and relationships across local and functional teams.
Facilitate efficiencies and smooth execution across the region's countries.
Requirements: Master's degree (scientific area) OR Bachelor's degree (scientific area) and 2 years of directly related experience.
Preferred knowledge: Degree and in-depth regulatory experience and/or related to the region.
Depth knowledge of regional countries legislation and regulations relating to medicinal products.
If you would like to discuss this vacancy further or to discuss your career options in confidence, please email me on: ****** If this role isn't suitable for you, please let us know if you can refer anyone – any recommendations are much appreciated!
Planet Pharma offers a competitive referral scheme so you will be rewarded for your help!
About Planet Pharma Planet Pharma is an American parented Employment Business/Agency that provides global staffing services with its head-quarters in Chicago and our EMEA regional office located in Central London.
We have invested significantly in creating a robust international platform that enables us to work compliantly in 30+ countries with a current network of 2500+ active contractors globally as well as a very strong permanent / direct hire recruitment offering.
Our specialist knowledge and close relationships with our clients and the wider industry really makes us unique in our field.
Just recently we were recognized by FORBES as the 17th best professional staffing firm, and have won multiple awards from industry accredited bodies for our commitment to excellence and service delivery.
We have extensive functional expertise including: Regulatory Affairs, Pharmacovigilance, QA, QC, Submissions experts, Clinical development, Quality, Biostatistics, and Medical Affairs / Writing.
We are an equal opportunities Recruitment Business and Agency.
We welcome applications from all suitably qualified candidates regardless of their race, sex, disability, religion/belief, sexual orientation or age