CMC Consultant (ATMP)

at  Advanced Resource Managers UK

ARM is proud to collaborate with a prestigious consultancy firm in the life science industry, presenting an exceptional permanent position. This role offers the unique opportunity to work closely with esteemed clients and diverse projects. Reserved for candidates ranking within the top 10% of the market, this role provides unparalleled flexibility, allowing individuals to tailor their workload without limitations on earning potential.
As the CMC Consultant (ATMP) your responsibilities will encompass all quality-related aspects, from pre-clinical development through to approved commercial products.

Responsibilities:

• Provide expert advice to clients on quality aspects of drug development and regulatory requirements, collaborating closely with cross-functional experts from the team.
• Ensure that CMC work packages and documentation are phase-appropriate, meeting regulatory expectations, and facilitating the approval of regulatory submissions.
• Prepare quality sections for Marketing Authorisation Applications (MAA), Biologics License Application/New Drug Application (BLA/NDA), Investigational Medicinal Product Dossier (IMPD), and Investigational New Drug (IND).
• Conduct gap analyses of client-provided packages, identifying critical CMC development issues and devising strategies for resolution.
• Support due diligence processes and prepare briefing packages for agency meetings, such as scientific advice, oral explanation, and End-of-Phase 2 (EoP2), conducting these meetings jointly with the client.
• Manage operational and strategic aspects with Contract Development and Manufacturing Organizations (CDMOs).
• Coordinate filing activities within the cross-functional team and with contributing parties, while ensuring continued adherence to regulatory guidance and regulations.

Requirements:

• PhD or master’s degree in Pharmacy, Chemistry, Biopharmaceuticals, Biochemistry, Biology, or equivalent.
• Minimum of ten years experience in a scientific/technical CMC development or CMC-regulatory affairs function.
• Experience with regulatory filings (IND/IMPD, BLA/NDA/MAA).
• Excellent communication and negotiation skills in English; proficiency in German is advantageous.
• Familiarity with CMC and regulatory requirements across all development stages, from pre-clinical to Phase III or commercial.
• Highly motivated team player with strong interpersonal abilities.
• Proficiency in Microsoft Office applications.
• Willingness to travel moderately for meetings with clients, agencies, or CMOs.

Disclaimer:
This vacancy is being advertised by either Advanced Resource Managers Limited, Advanced Resource Managers IT Limited or Advanced Resource Managers Engineering Limited ("ARM"). ARM is a specialist talent acquisition and management consultancy. We provide technical contingency recruitment and a portfolio of more complex resource solutions. Our specialist recruitment divisions cover the entire technical arena, including some of the most economically and strategically important industries in the UK and the world today. We will never send your CV without your permission.

• Provide expert advice to clients on quality aspects of drug development and regulatory requirements, collaborating closely with cross-functional experts from the team.
• Ensure that CMC work packages and documentation are phase-appropriate, meeting regulatory expectations, and facilitating the approval of regulatory submissions.
• Prepare quality sections for Marketing Authorisation Applications (MAA), Biologics License Application/New Drug Application (BLA/NDA), Investigational Medicinal Product Dossier (IMPD), and Investigational New Drug (IND).
• Conduct gap analyses of client-provided packages, identifying critical CMC development issues and devising strategies for resolution.
• Support due diligence processes and prepare briefing packages for agency meetings, such as scientific advice, oral explanation, and End-of-Phase 2 (EoP2), conducting these meetings jointly with the client.
• Manage operational and strategic aspects with Contract Development and Manufacturing Organizations (CDMOs).
• Coordinate filing activities within the cross-functional team and with contributing parties, while ensuring continued adherence to regulatory guidance and regulations