CMC Regulatory Affairs Manager
Reporting to the Head of Regulatory Affairs, the successful candidate will lead the CMC regulatory function and collaborate cross-functionally to develop the CMC regulatory strategy, provide guidance to the CMC subject matter experts, and drive the CMC regulatory submissions to facilitate the global development of the investigational biologics compounds (recombinant proteins, antibody drug conjugates, monoclonal antibodies amongst others). This position is primarily for the biologics portfolio with some support as needed to the cell therapy division of the company.
Key activities and responsibilities
- Lead preparation, coordination, review, and maintenance of CMC content in regulatory submissions (e.g., INDs and CTAs, Briefing Documents, BLA/NDA/MAA), to ensure timelines and corporate goals are met.
- Represent regulatory function in CMC subteam, and develop CMC regulatory strategies.
- Provide regulatory CMC advice and direction, including the interpretation and application of global CMC regulations and guidance.
- Manage technical assessment of CMC source documentation and responses to technical questions on document content.
- Proactively identify potential CMC program risks and implement appropriate regulatory mitigation strategies to support successful CTA/IND/NDA/MAA submissions.
- Oversee and ensure compliance with quality assurance and regulatory procedures and work practice.
- Initiate and/or contribute to process improvements which have an impact on Regulatory Affairs or other departments.
- Develop and implement regulatory operating guidelines/SOPs for regulatory CMC activities and common work practices/strategies within the team. - Involvement in preparation for and management of CMC interactions with Regulatory Agencies.
- Train, mentor and supervise, as needed, regulatory employees, consultants/contractors in CMC Regulatory Affairs.
Competences, skills and qualification
- Bachelor’s Degree in life sciences at a minimum
- At least 8+ years of experience in CMC-related/relevant function(s) including CMC Regulatory Affairs within a pharma/biotechnology company
- Established working knowledge of global regulatory guidelines and regulations (US and EU primarily) gained through leading and/or heavily contributing to several IMPDs/Module 2 QoS/Module 3 of CTAs/INDs/BLAs/MAAs from a CMC/CMC regulatory affairs perspective
- Direct experience leading regulatory CMC aspects of biologics is essential, global experience (both US and EU) preferred; experience with small molecule, extensive post-marketing regulatory CMC experience, US and EU drug/device regulations and guidance is desirable.
- Successful CMC submissions and managing responses to CMC questions from EU agencies, FDA; demonstrated evidence of writing & project managing the writing of CMC regulatory documentation (EU CTA/MAA, FDA IND/BLA/NDA) with internal and external parties.
- Strong CTD/eCTD knowledge and regulatory writing skills
- Detail oriented with excellent oral and written communication skills, including proficiency in scientific writing, and experience interfacing with CMC, cGMP Quality Assurance, and contract manufacturing organizations (CMOs)
- Strong organizational skills and ability to maintain a high level of communication, productivity, innovation, and priority-setting to work effectively in a dynamic environment to meet aggressive timelines
- Strong knowledge of cGMP for biologics, ATMP and small molecule, and CMC Regulatory Affairs
- Self-motivated, self-disciplined, and able to function independently as well as part of a team
- Strategic agility, strong critical and logical thinking with ability to analyze and propose solutions to problems
- Good project management skills
- Good computer proficiency (MS Word, Excel, PowerPoint, Adobe Acrobat etc)