Ethypharm
Senior RA Officer
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Job title: Senior RA Officer
Location: Romford, (Hybrid)
Contract Type: Permanent
Working Hours: Monday - Friday, 8:30am - 5:00pm
Right to work: Please note that Ethypharm is unable to provide sponsorship for this role. Applicants must already have the right to work in the UK.
What you will do:
The Senior Regulatory Affairs Officer is responsible for leading UK regulatory and CMC lifecycle activities for assigned products, ensuring compliance with MHRA and applicable EU/international requirements. The role provides strategic regulatory advice, manages complex post-approval submissions, supports business-critical projects, and acts as a technical mentor for junior team members and new starters.
Your key responsibilities include:
- Preparation of regulatory strategies for expediting new registrations and complex post approval changes
- Plan, prepare and compile high quality documentation for new registrations according to CTD requirements (Modules 1 to 5)
- Co-ordinate and / or prepare review, submit and subsequently manage applications to designated Regulatory Authorities in a timely manner
- Liaise with manufacturing, commercial, medical affairs and pharmaceutical development as well as external regulatory contacts (including regulatory agencies) to ensure all regulatory requirements for these submissions are met
- Actively manage regulatory procedures for the review and approval of these submissions
- Provide high quality regulatory advice on most efficient strategy for preparation, submission and approval of these submissions
- Provide forward plans for the preparation, submission and approval of these submissions including timelines for implementation and launch to manage organisational expectations and budgetary requirements (including correct fee payment to the authorities)
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About you
You will be an experienced Regulatory Affairs professional with a strong understanding of pharmaceutical regulations and submission requirements. Organised and confident managing multiple priorities, you will work well with colleagues across the business and communicate clearly with regulatory authorities. You will have excellent attention to detail, a practical approach to problem-solving and the confidence to take ownership of your work.
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Basic skills and qualifications:
- Educated to degree level, ideally in Pharmacy, chemistry or life sciences
- Minimum of 5 years Regulatory Affairs experience which includes the Preparation of modules for the regulatory dossier in eCTD format, submission of variations, renewals new licence application submissions using national country specific procedures.
- Good knowledge of CTD dossier writing especially Modules 1 to 3.
What we offer you
- Competitive salary
- Holiday - 25 days rising to 30 with length of service plus bank holidays
- Holiday Buy/Sell - an opportunity to buy or sell up to an additional 5 days' holiday
- 5% Bonus - In addition to our competitive salaries, all our employees are entitled to join a discretionary bonus scheme (based on policy eligibility)
- Bravo Benefits Platform - offering a variety of discounts across well-being and lifestyle
- Salary Sacrifice scheme for Electric vehicles with Tusker (dependent on meeting policy eligibility)
- Private Healthcare for yourself and your family (if applicable) with an additional Medicash health cash plan
- Pension Scheme
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