Job Description

Job Description

Your new company
Hays Life Sciences are exclusively partnered with a dynamic, mid-sized pharmaceutical company focused on the development and registration of high-quality drug products. They are currently seeking a highly skilled and motivated Product Development Lead to join their growing team in London and support the development of a number of products for the UK and European markets.
The company has undergone steady growth over the last few years and this new position, driven by their expanding R&D efforts, has the opportunity to make a strong impact on the business.
They are very serious about staff development and so there are plenty of opportunities for training and development to enhance your career with them.

Your new role
This is a permanent role, working on a hybrid basis, with 3 days at the company's offices in Central London.
You'll be joining an established team and working closely with the Head of R&D as well as other senior stakeholders and external vendors to deliver research programmes across multiple oral dosage forms and ensure the company has the information they need to make successful applications to the MHRA and EMA, including gathering information for Module 3 and Module 5 submissions.
Major responsibilities will include:

• Lead and manage all aspects of drug product development, with a focus on oral dosage forms (liquids, tablets, capsules).
• Develop and implement CMC strategies aligned with product characteristics and regulatory requirements.
• Coordinate and oversee bioequivalence studies and clinical development activities being performed by CROs and clinical teams.
• Support the preparation and review of Module 3 and Module 5 documentation for regulatory submissions (e.g., IMPD).
• Liaise with external CMOs and CROs to gather essential data (e.g., stability tables) and ensure timely project execution.
• Support regulatory submissions by ensuring dossier sections (eg CTD) are complete / have the relevant information, and responding to health authority queries.
• Manage development timelines and adjust strategies based on data and project needs.
• Provide leadership and mentorship to junior staff, with potential line management responsibilities as the department continues to grow.
• Engage with internal and external stakeholders, including clinical experts, to align development goals.

What you'll need to succeed
You should have:

• A strong track record in managing finished product development programs, preferably across multiple oral dosage forms (although training is available).
• Good understanding of EU/UK regulatory requirements, including CTD content and clinical development pathways.
• Proven experience coordinating with CROs and CMOs, and managing bioequivalence and other studies.
• Hands-on experience preparing sections for regulatory documentation, including IMPD, Module 3 and 5 from a technical/scientific perspective (rather than as a regulatory professional).
• Knowledge of GMP, quality systems, and regulatory expectations for pharmaceutical development.
• A degree (or equivalent experience) in Chemistry, Pharmacy, Biology, Management or a similar subject.
• Excellent communication, project management, and time management skills.
• Experience supervising and/or managing junior staff is a distinct advantage but not a prerequisite for the role.

What you'll get in return
As well as flexible/hybrid working, you'll be joining a growing team within a highly successful business that has a number of products on the market already and a significant pipeline that it is looking to get approved within the next few years.
The company has a good corporate atmosphere and plenty of chances for personal development, training and progression.

What you need to do now
If you're interested in this role, click 'apply now' to forward an up-to-date copy of your CV, or call us now.
If this job isn't quite right for you but you are looking for a new position, please contact us for a confidential discussion on your career.

Keywords: CMC, pharmaceutical, development, regulatory, bioequivalence, clinical, CRO, CMO, oral, dosage, tablets, capsules, liquids, GMP, CTD, IMPD, Module 3, Module 5, submissions, product, strategy, stability, audits, QP, drug, registration, formulation, project, management, training, research, development