Summary: The Senior Manager Regulatory Affairs CMC Biosimilars at ADVANZ PHARMA will lead strategic regulatory assessments and scientific evaluations of CMC aspects for biological products, ensuring efficient pathways to market. This role requires collaboration with various teams and stakeholders to manage regulatory activities for new pipeline projects and M&A initiatives. The position involves direct communication with regulatory authorities and the preparation of necessary documentation for marketing authorizations. The ideal candidate will possess extensive experience in regulatory affairs within the biopharma industry, particularly in biosimilars.

Key Responsibilities:

• Contribute to the preparation of briefing packages for Scientific Advice of Biosimilar products.
• Participate during interactions with Competent Authorities (EMA, National EU Authorities, Health Canada, TGA, and others).
• Address issues/requests by the Agency during MAA.
• Preparation of regulatory roadmaps and gap analysis for the development of biosimilars up to approval.
• Writing or review of IMPD CMC sections if required.
• Writing or review of Modules 2.3 and 3 of the CTD for MAA and LCM variations.
• Provide support and guidance to the BD&L Team when evaluating new projects and M&A by conducting dossier due diligence.
• Direct communication with regulatory authorities to facilitate productive dialogue when required.
• Timely and accurate responses to all regulatory queries in relation to Regulatory Affairs-New Products group activities.
• Alliance Management of the relationship with all new partners and their regulatory departments to ensure timely feedback to all queries.
• Report on regulatory progress and issues for new products or LCM activities at all project team and Project Review Meetings, and to Senior Management as required.
• Escalate risks/issues appropriately to remove barriers to success or advise of delays and other changes which may impact the regulatory approval timeline.
• Propose improvements or alternative approaches to obtain improved project deliverables.

Key Skills:

• University degree in a scientific discipline.
• Additional Regulatory professional qualifications.
• Regulatory role in CMC writing and assessment in Bio Pharma Industry (at least 8 years +).
• Broad understanding and experience preparing Common Technical Dossiers.
• Relevant and current experience in submissions/managing of National and European MAA and support product launches.
• Experience working with Biologic and Biosimilar applications.
• Experience working with Generic and NCE applications.
• Experience interacting with EU regulatory authorities.
• Scientific advice meetings/Pre-submission meetings experience.
• International Regulatory experience.
• Broad knowledge and awareness of the European regulatory guidelines and legislation.
• Use of electronic portals for dossier submissions.
• Good understanding of early development programs including non-clinical studies and clinical development plans for multiple indications, especially of Biosimilar products.
• Broad knowledge of the CMC development aspects of a Biosimilar product.
• Good working knowledge of Regulatory IT systems.
• Strong project management skills.
• Excellent communication skills: verbal, written, and presentation.
• Ability to work under pressure and to tight deadlines.
• Influencing / Assertiveness.
• Excellent interpersonal and influencing skills to a broad audience, including Senior Management.
• Trustworthy and collaborative, strong team player.
• Excellent organizational skills and experience managing multiple regulatory projects.
• Attention to detail and focus on Quality.
• Problem-solving and solutions-oriented.
• Analytical mind-set, with good problem-solving skills.

Salary (Rate): undetermined

City: London

Country: United Kingdom

Working Arrangements: undetermined

IR35 Status: undetermined

Seniority Level: undetermined

Industry: Other