REGULATORY AFFAIRS CMC MANAGER - COMBINATION PRODUCTS

We are looking for a Regulatory Affairs CMC Manager to join a growing team at an award-winning CRO. In this role, you will be embedded in the regulatory CMC team of a top 20 biopharmaceutical company that has been partnering with our client for over 10 years. You will support their regulatory CMC team with drug-device combination product submissions.

​

This is a full-time, permanent contract role. The role can be based remotely from anywhere in the UK or Portugal.

​

This role requires expertise in regulatory CMC for pharmaceuticals as well as medical devices (drug-device combination products – prefilled syringe, pen injectables, inhalers, and/or other products and formulations). The RA CMC Manager will be responsible for assisting in the development and execution of regulatory CMC strategies for combination products, as well as the preparation and maintenance of the device Design History Files (DHFs), General Safety and Performance Requirements (GSPR), and other CMC documents for regulatory submissions to ensure compliance with global (mainly the US and the EU) regulatory requirements. The manager will help integrate the drug's chemical/biological and manufacturing information with the device design documentation to ensure a cohesive regulatory strategy.

​

Responsibilities

• Prepare, compile and author as needed, high-quality regulatory CMC documents to support development, registration and/or lifecycle maintenance submissions, including DHFs, GSPR documents and technical files for medical devices, to regulatory authorities in the US and Europe.

• Ensure all regulatory submissions for combination products meet current regulatory requirements and guidelines, such as FDA's 21 CFR Part 4, 21 CFR 820, EU Medical Device Regulation (MDR), and relevant ICH guidelines.

• Collaborate with R&D, Quality Assurance, Manufacturing, and Clinical teams to ensure alignment on regulatory requirements and strategies.

• Provide regulatory CMC expertise to ensure compliance and successful product submissions.

• Preparation, update and maintenance of Design History Files (DHFs), General Safety and Performance Requirements (GSPR), and technical documentation, ensuring alignment with regulatory requirements and company standards.

• Support risk assessment and risk management activities by conducting risk assessments and developing mitigation strategies for combination products.

• Monitor changes in global regulatory requirements for drug-device combination products and communicate implications to stakeholders, updating regulatory strategies and documentation as needed.

• Update, create and ensure timely implementation of company SOPs and compliance requirements.

​

Knowledge and experience needed

• Bachelor’s degree or an advanced degree level in a scientific field, or related background.

• 5+ years of regulatory affairs CMC experience. Demonstrated experience with global regulatory submissions (preparation and authoring of CMC sections of NDAs or MAAs etc.) and interactions with regulatory agencies.

• Experience in regulatory affairs CMC for drug-device combination products or other medical device regulatory affairs for major markets.  

• Strong understanding of ICH, GMP, QSR and MDR requirements and regulations, quality systems, risk management and design control process.

• Familiarity with ISO 13485, ISO 14971, and other relevant standards for medical devices and combination products would be preferred.

• Experience with 510(k), PMAs and preparing and maintaining DHFs and GSPR documentation would be an advantage.

• Excellent written and verbal communication skills.

• Ability to work effectively in cross-functional teams and lead collaborative efforts across departments.

​

What You Get in Return​

• Competitive Salary and Benefits: Attractive compensation package, including health insurance, pension plans, and more depending on your location.

• Professional Development: Opportunities for continuous learning and career advancement in a supportive, collaborative, and innovative environment.

• Impactful Work: Contribute to groundbreaking research that makes a real difference in patients' lives.

• Collaborative Culture: Join an international team of passionate professionals dedicated to excellence in clinical research.

​

How to Apply

Get in touch with Oli Dimitrov for more information on oli.dimitrov@anttalent.com or call +44 208 135 5914, or click on the apply button to send us your CV or register your interest. We will be in touch as soon as possible.

​

Ant Talent - Who We Are

We are a boutique recruitment agency working closely with select clients in the pharmaceutical industry, focusing mainly on Medical & Regulatory Affairs. We pride ourselves on identifying and recruiting the best professionals for our clients and finding the best employers for our candidates. Do you feel ready to take the next step in your career? Get in touch! We are here to support you every step of the way.