Regulatory Operations Officer - Maternity Cover

Ethypharm; Wooburn Green; On-site; GBP 42,000 - 54,000; Full time

Benefits offered by this job

Holiday

Holiday Buy/Sell

Bonus

Bravo Benefits

EV salary sacrifice

Private Healthcare

Pension

Job summary

Ethypharm is seeking a Regulatory Operations Officer for a 12-month maternity cover in Wooburn Green, Buckinghamshire. You will manage day-to-day regulatory publishing, support global submissions, and maintain regulatory documents and systems.

Ideal candidates will hold a Bachelor's degree and have experience in Regulatory Affairs or regulatory publishing, with familiarity in NeeS/eCTD submissions and electronic submission tools. Full-time, Mon-Fri 8:30-5; on-site role with benefits.

Qualifications

• Bachelor's degree or equivalent.
• Experience in Regulatory Affairs, Regulatory Operations or regulatory publishing would be advantageous.
• Knowledge of NeeS and eCTD submission formats would be advantageous.
• Experience with regulatory publishing systems would be beneficial.
• Experience with regulatory documentation, electronic submissions or document-management systems would be advantageous.

Responsibilities

• Regulatory Publishing: manage day-to-day regulatory publishing and support high-quality submissions.
• Global Regulatory Submissions: support end-to-end submission process for MAAs, variations, renewals and agency responses.
• Submission Preparation & Quality Control: compile, publish, and validate submission packages.

Skills

Regulatory operations

Regulatory publishing

Regulatory affairs

Education

Bachelor's degree

Tools

NeeS/eCTD knowledge

Job description

Regulatory Operations Officer - Maternity Cover

Location: Wooburn Green - Buckinghamshire
Contract Type: Full-time, 12M FTC
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:

This is a key operational role supporting the effective delivery of global regulatory submissions and regulatory lifecycle activities. The Regulatory Operations Officer will manage day-to-day regulatory publishing activities, provide operational support for regulatory submissions and agency responses, and ensure regulatory documentation and systems are maintained effectively.

Your key responsibilities include:

• Regulatory Publishing: Manage day-to-day regulatory publishing activities and support the preparation and delivery of high-quality regulatory submissions.
• Global Regulatory Submissions: Support the end-to-end submission process for global regulatory filings, including Marketing Authorisation Applications (MAAs - CTD/eCTD), variations, renewals, PSURs and agency responses.
• Submission Preparation & Quality Control: Compile, publish, quality-control check and validate regulatory documents and submission packages to ensure they meet applicable technical and regulatory requirements.
• Submission Planning & Tracking: Develop and maintain regulatory submission plans, coordinate required documentation and provide project status updates to support timely delivery against agreed regulatory strategies and timelines.
• Regulatory Systems & Documentation: Maintain regulatory documentation, folder structures and associated systems to ensure information is appropriately organised, controlled, traceable and readily retrievable.
• Document & Records Management: Support electronic document management and regulatory archiving processes and contribute to the development and maintenance of Regulatory Operations and records-management procedures and SOPs.
• Technical Document Support: Provide advanced editing, formatting and troubleshooting support for regulatory documents, including resolving issues within Microsoft Word and Adobe Acrobat.
• Compliance & Risk Management: Identify and **escalate** potential electronic regulatory submission compliance risks and support appropriate actions to minimise their impact.
• Process Improvement: Proactively identify and implement improvements to Regulatory Operations tools, systems, methodologies and processes to increase efficiency, quality and consistency.
• Cross-functional Collaboration: Work closely with Regulatory Affairs colleagues and project teams to proactively plan and coordinate regulatory submissions and global registration activities.

About you

An effective communicator who works well independently and within a team, you'll take a proactive, practical approach to solving problems and providing accurate, high-quality support to Regulatory Affairs and wider project teams.

Basic skills and qualifications:

• Bachelor's degree or equivalent.
• Previous experience within Regulatory Affairs, Regulatory Operations, regulatory publishing or the pharmaceutical industry would be advantageous.
• Knowledge or understanding of NeeS and eCTD submission formats would be advantageous.
• Knowledge or experience of regulatory publishing systems would be beneficial.
• Experience working with regulatory documentation, electronic submissions or document-management systems would be advantageous.

What we offer you

• 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
• 3% 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

About us:

Ethypharm is a leading mid-sized international pharmaceutical company, with strong European roots, that manufactures and provides essential medicines, with a focus on hospital care, central nervous system (severe pain and addiction) and internal medicine.

Ethypharm has 1,700 employees dedicated to its various pharmaceutical activities, of which 1400 are in industrial operations. Our six production sites located in France, the UK, Spain, and China have expertise in injectables and complex oral solid forms.

At Ethypharm, you will be a part of a team dedicated and committed to improving patients' lives.

Our Romford facility located 20 miles from the centre of London, consists of over 6700 square metres of a high-quality, modern pharmaceutical facility where we mix, fill, sterilise, inspect, pack, and label a wide range of medicines.

Why Ethypharm?

We provide a workplace which is one of collaboration, teamwork and innovation. We are all different and we embrace this uniqueness in each and every one of our employees. Our commitment to you is that we want to help you unleash your full potential by supporting your training and development. We want you to be the best that you can be.

At Ethypharm we recognise the value of diversity in the workplace and provide equal opportunities for all. We are always open to discussing flexible working arrangements where this meets with the needs of our business.