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Position Summary

• Provide appropriate CMC regulatory strategy in each stage of development, approval review (JNDA/s JNDA), and life cycle management in order to achieve BMSKK business goal, and execute tasks according to this strategy. For that objective, obtain information from the inside/outside of BMSKK and understand the latest regulatory requirements. In addition, communicate appropriately with regulatory authorities (Pharmaceuticals and Medical Devices Agency (PMDA) / Ministry of Health, Labour and Welfare).
• Take part in the development team and JNDA/s JNDA team. Propose CMC regulatory strategy by himself or herself, and execute tasks. Align with colleagues for not only task execution but also knowledge/skill acquisition.

Roles& Responsibilities

Fulfill his/her responsibilities in the stage of development, approval review (JNDA/s JNDA) and life cycle management while considering the instruction/guidance from supervisors/superiors based on his/her own judgement.

• Carry out risk assessment in each stage. As necessary, propose and implement risk management plan.
• Contribute to cross-functional team through having regulatory discussion from CMC regulatory aspects and providing appropriate information regarding the development strategy.
• Provide regulatory and technical advice to related parties including Global teams.
• Align with colleagues for not only task execution but also knowledge/skill acquisition.
• Support junior colleagues' responsibilities.

Development:

• Provide information needed for Clinical Trial Notification (CTN). If necessary, cooperate with global team and prepare CMC-related attached documents for CTN in consideration of submission timing.
• Provide information to Global team in order to develop pharmaceutical products that are acceptable in Japan.
• Evaluate the necessity of PMDA consultation for biologics based on outcomes of other countries in collaboration with Global team, if critical manufacturing process change is needed and/or development plan, which will impact products quality, is developed.
• Evaluate excipients from viewpoints of new excipients (precedence of excipients) and biological ingredients standard and share the information to relevant department if necessary.

Approval review (JNDA/s JNDA):

• PMDA Consultation: Plan strategies and gain agreement through discussion with Global team in order to receive expected response. Prepare documents according to the strategies.
• CTD Preparation: Prepare CTD through discussion with Global team that the contents of CTD meet the regulatory requirements and are aligned with agreement with Global team.
• GMP/GCTP inspection: Provide the information on the manufacturing sites, etc. listed in the application form for marketing approval to the lead department, and provide support. In the on-site inspection, accompany as a member of the marketing authorization holder and support the inspection mainly from the viewpoint of the content of the application form for marketing approval.
• Communication with the authorities: Regarding the PMDA consultations and approval review etc., submit responses prepared as outlined in the agreement of Global team through explanation on meaning of queries, discussion and negotiation for generation of the best responses. Plan to hold a F2F meeting with the authorities, if necessary.

Life cycle management:

• Based on the information of change control initiated by manufacturing department, 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 based on the information of manufacturing department.
• If inquiries on commercial products arises from outside of BMS, take appropriate actions in cooperation with related parties (Medical information, etc.).
• Facilitate inquiries/support from the parties related the product quality (manufacturing department, GQP, etc.).
• Inform supervisor when negotiation with other parties is necessary in order to facilitate task related to the life cycle management.

Qualifications

Experience and knowledge in many of the following application items (JNDA/s JNDA 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 items;

• 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

If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.

Uniquely Interesting Work, Life-changing Careers
With a single vision as inspiring as Transforming patients' lives through science™ , every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

On-site Protocol

BMS has a diverse occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:

Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the 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.

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com . Visit careers.bms.com/ eeo -accessibility to access our complete Equal Employment Opportunity statement.

BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.

BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/

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