Senior Manager, Regulatory Strategy

Working with Us
Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible.

Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us.

High-level description; including manage team/individuals or not

Contribute to developing valuable new drugs by providing and implementing optimal regulatory strategy in order to achieve BMSKK business target. For that objective, have a deep knowledge of up-to-date regulatory affairs and improve the quality of communication with regulatory authorities (PMDA/MHLW). In addition, provide mitigation plans for regulatory risks in order to deal with unforeseen situation in the development of new drugs.

Roles & responsibilities

Perform following roles and take responsibilities. In addition, confirm that staffs fulfill the following roles properly, and provide them necessary support after sharing all staffs’ responsibilities. Engage internal and external stakeholders to lead to resolve and to coordinate issues in relation to the work undertaken by the project or department

Development stage:

• Provide appropriate input from a regulatory perspective to the new drug development plan, and thereby contribute to prepare an appropriate development plan.
• Contribute to the development team in order to ensure that the J-HAs (PMDA, MHLW) accept clinical study plans and the clinical studies are initiated as planned.
• Decide whether J-HA interactions (PMDA consultation, Preliminary meeting etc.) are needed. When it is decided that a J-HA interaction is needed, prepare a consultation strategy to ensure that the proposed development plan is accepted by the J-HA.
• Identify and assess the regulatory risks and notify all relevant colleagues of these risks, and propose risk minimization or mitigation plans and lead discussion with relevant personnel.
• Provide appropriate advice to ensure that query responses related to CTNs and/or PMDA consultation can be submitted within the deadlines, and to ensure that the responses submitted are high-quality responses that will not provoke additional queries.
• Collaborate with the GRL regarding the preparation of the regulatory strategy toward early JNDA and approval, and keep good relationship and well communication with all relevant GRL/Global team colleagues.

Approval application/review stage:

• Propose and take the lead on the work that is required to obtain, for example, Orphan drug or Priority review designations to maximize value of asset .
• Propose and build consensus on the probability of regulatory success for approval.
• Lead the JNDA team to complete the JNDA/sJNDA filing as planned in accordance with preparation timeline of approval data.
• Determine whether a pre-JNDA consultation should be held. If it is determined that a pre-JNDA consultation is needed, then prepare consultation strategies to ensure that the regulatory authorities accept proposed development plan.
• Manage teams in order to submit query responses in a timely manner without having impacts on application period. Identify problems at an early stage during the JNDA/sJNDA review and lead the preparation of either resolutions or alternative plans.
• Collaborate with the GRL regarding the JNDA/sJNDA review plans and progress, and maintain good relationship and well communication with all relevant GRL/Global team colleagues. Identify and assess the regulatory risks in JNDA review and notify all relevant colleagues of these risks, and propose risk minimization or mitigation plans and lead discussion with relevant personnel

Regulatory Strategy/Intelligence:

• By understanding science and regulations, lead the strategic planning of the regulatory department and provide regulatory guidance.
• Lead regulatory intelligence and aim to achieve strategic and operational excellence across disease areas.
• Contribute to the formulation and improvement of regulatory-related processes both within and outside the company.

Culture:

• Developing and promoting workplace culture that values diversity of thought, promotes integrity and creates an atmosphere that supports and fosters accountability.

Coaching and training of staffs:

• Support colleagues and if necessary, negotiate and solve problems.

Building and improving the organization:

• Understand the policies of the company and organization, and play a role in their implementation.

Required knowledge/skills

• Required Knowledge: Up-to-date regulatory knowledge required to do the job with high quality as described above, and knowledge & experience with new drug development work.
• Required Skills: General business communication skills, presentation skills, strategic thinking ability, negotiation skills, leadership skills, problem-solving ability, Mentoring and facilitation 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 a supportive culture, promoting global participation 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 an 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.

Supporting People with Disabilities

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.

Candidate Rights

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/

Data Protection

We will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at https://careers.bms.com/fraud-protection.

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

If you believe that the job posting is missing information required by local law or incorrect in any way, please contact BMS at TAEnablement@bms.com. Please provide the Job Title and Requisition number so we can review. Communications related to your application should not be sent to this email and you will not receive a response. Inquiries related to the status of your application should be directed to Chat with Ripley.

R1601770 : Senior Manager, Regulatory Strategy