Bristol Myers Squibb
Manager,CMCRegulatory
“Manager, CMC Regulatory at Bristol Myers Squibb. Skills: CMC regulatory strategy, JNDA/sJNDA and Partial Change Application, PMDA Consultation, CTD Preparation, GMP/GCTP inspection, Life cycle management. Provide appropriate CMC regulatory strategy in each stage of development, approval review (JNDA/sJNDA), and life cycle management. Execute tasks according to strategy”
What You'll Achieve.
Achieve BMSKK business goal
Industry & Context.
Risk assessment; Propose and implement risk management plan; Discussion and negotiation for generation of the best responses
Ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.
What They're Looking For.
Must Have
Experience and knowledge in many of the following application items (JNDA/sJNDA and Partial Change Application), Preparation of application documents (Application form and CTD), Preparation of submission documents for Minor Change Notification, JAN application, GMP/GCTP inspection (domestic and overseas), Foreign Manufacturer Accreditation, Master File (coordination with In-Country Caretaker), Experience or knowledge in many of the following, Japanese Pharmacopoeia, Organic synthesis, chemical analysis, protein chemistry, biochemistry, and microbiology, Pharmaceutical development, Manufacturing control and quality control (GMP, GCTP, GQP), English Communication skill, Can attend meetings (including audio conference) with global teams and carry out tasks by him/herself., Negotiation skills, Leadership skills
What You'll Do.
Provide appropriate CMC regulatory strategy in each stage of development
approval review (JNDA/sJNDA)
and life cycle management
Execute tasks according to strategy
Obtain information from the inside/outside of BMSKK and understand the latest regulatory requirements
Communicate appropriately with regulatory authorities (PMDA / Ministry of Health
Take part in the development team and JNDA/sJNDA team
Propose CMC regulatory strategy
Carry out risk assessment in each stage
Propose and implement risk management plan
Contribute to cross-functional team
Provide regulatory and technical advice
Support junior colleagues’ responsibilities
Provide information needed for Clinical Trial Notification (CTN)
Cooperate with global team and prepare CMC-related attached documents for CTN
Provide information to Global team in order to develop pharmaceutical products that are acceptable in Japan
Evaluate the necessity of PMDA consultation for biologics
Evaluate excipients from viewpoints of new excipients and biological ingredients standard
Plan strategies and gain agreement through discussion with Global team for PMDA consultations
Prepare documents according to strategies
Prepare CTD through discussion with Global team
Provide the information on the manufacturing sites
etc. listed in the application form for marketing approval
Support GMP/GCTP inspection
Accompany as a member of the marketing authorization holder and support the inspection
Submit responses prepared as outlined in the agreement of Global team
Plan to hold a F2F meeting with the authorities
Propose appropriate regulatory strategy and execute regulatory tasks in the point of view of product supply and the situation of Product Assurance and Marketing
Control approval timing of the partial change application
Take appropriate actions in cooperation with related parties (Medical information
etc.) for inquiries on commercial products
Facilitate inquiries/support from the parties related the product quality
Inform supervisor when negotiation with other parties is necessary
How You'll Work.
Team & Collaboration
Take part in the development team and JNDA/sJNDA team; Align with colleagues for not only task execution but also knowledge/skill acquisition; Contribute to cross-functional team; Provide regulatory and technical advice to related parties including Global teams; Cooperate with global team; Discussion with Global team; Discussion with the authorities; Cooperation with related parties
Communication Scope
English Communication skill; Communicate appropriately with regulatory authorities; Communication with the authorities; Explanation on meaning of queries; Discussion and negotiation
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