Bristol Myers Squibb
Pharmaceuticals
SeniorManager,CMCRegulatory
“Senior Manager, CMC Regulatory at Bristol Myers Squibb. Skills: CMC Regulatory, Regulatory Affairs, Submission Preparation, CTD Preparation, GMP/GCTP Compliance, Global Regulatory Strategy. Conduct risk assessments at each stage and develop/execute risk management plans as needed. Contribute to cross-functional teams by conducting regulatory discussions from a CMC regulatory perspective and providing appropriate information on development strategy”
Industry & Context.
Strategically and logically address complex regulatory issues
Ability to travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed (for field-based and remote-by-design roles)
What They're Looking For.
Must Have
10 years of practical experience and sufficient expertise in regulatory affairs, Experience in managing multiple projects simultaneously, Experience in preparing regulatory submissions and CTD, Experience in preparing minor change notifications, Experience in JAN application response, Experience in GMP/GCTP inspection response (domestic and overseas), Experience in foreign manufacturer accreditation, Experience in master file management (coordination with In-Country Caretaker), Experience or knowledge in Japanese Pharmacopoeia, Experience or knowledge in organic synthesis, Experience or knowledge in chemical analysis, Experience or knowledge in protein chemistry, Experience or knowledge in biochemistry, Experience or knowledge in microbiology, Experience or knowledge in formulation development, Experience or knowledge in manufacturing management and quality control (GMP, GCTP, GQP), English communication skills: ability to participate in meetings (including teleconferences) with global teams independently and perform duties, Excellent negotiation skills, Leadership skills, Coaching skills, Ability to strategically and logically address complex regulatory issues, Ability to flexibly adapt to a rapidly changing global environment, Proactive attitude with a sense of responsibility towards the team, Ability to make decisions while balancing business objectives and regulatory requirements, High ethical standards and compliance awareness
Nice to Have
Experience in preparing submissions and CTD for biopharmaceuticals and regenerative medicine products
What You'll Do.
Conduct risk assessments at each stage and develop/execute risk management plans as needed
Contribute to cross-functional teams by conducting regulatory discussions from a CMC regulatory perspective and providing appropriate information on development strategy
Provide regulatory and technical advice to relevant departments
including global teams
Lead and support team members utilizing own knowledge and skills
Provide information required for Investigational New Drug (IND) applications and prepare IND-related documents considering submission timing
coordinating with global teams as necessary
Provide information to global teams for the development of pharmaceuticals acceptable in Japan
Evaluate the necessity of PMDA consultations based on results from other countries
coordinating with global teams when significant manufacturing process changes or development plans affecting product quality arise
Evaluate excipients from the perspective of Japanese Pharmacopoeia and standards for raw materials of biological origin
sharing information with relevant departments as needed
Plan strategy through consultation with global teams for PMDA consultations
build consensus to obtain expected answers
and prepare documents based on the strategy
discussing to ensure content meets regulatory requirements and aligns with global team consensus
and support team members in CTD preparation
Provide information on manufacturing sites listed in the marketing authorization application to the responsible department and support them for GMP/GCTP inspections
Accompany and support as a member of the marketing authorization holder during on-site inspections
focusing on the perspective of the marketing authorization application content
Submit responses to inquiries from authorities during PMDA consultations
through background explanation
based on global team consensus
Plan face-to-face meetings with authorities as necessary
Propose appropriate regulatory strategies and execute regulatory operations based on change management information from the manufacturing department
considering product supply
Manage the application and approval timing for variations based on change information from the manufacturing department
Coordinate with relevant departments to take appropriate action when inquiries arise regarding marketed products
Respond to inquiries from the quality department and provide necessary support
Collaborate with other departments to ensure smooth progress of lifecycle management related tasks
How You'll Work.
Team & Collaboration
Contribute to cross-functional teams by providing regulatory information and advice; Provide regulatory and technical advice to relevant departments, including global teams; Lead and support team members; Coordinate with global teams for IND applications and submission timing; Coordinate with global teams for evaluating PMDA consultation necessity; Discuss with global teams for CTD preparation; Coordinate with global teams for responses to authorities; Collaborate with manufacturing department for change management information; Coordinate with relevant departments for inquiries regarding marketed products; Respond to inquiries from the quality department; Collaborate with other departments for lifecycle management
Communication Scope
English communication; Negotiation
Process & Methodology
Managing multiple projects simultaneously
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