Director/Sr. Director, Global Regulatory Sciences CMC - China & Intercon
At Bristol Myers Squibb, we are inspired by a single vision – transforming patients’ lives through science. In oncology, hematology, immunology and cardiovascular disease – and one of the most diverse and promising pipelines in the industry – each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.
The (Director/Sr. Director) Global Regulatory Sciences - CMC (GRS-CMC), China/Intercon Liaison will facilitate interactions between the global regulatory CMC team and the local regulatory teams, with an initial focus on improving our business process to support the BMS China Strategy. He/she will also partner with key stakeholders in the Global Product Development and Supply organization to ensure technical teams are aware of any region-specific regulatory requirements. He/she will report to the Vice President of GRS-CMC and be a member of the leadership team. Initially, the individual will also represent GRS-CMC on cross-functional initiatives working to optimize our process and procedures in support of these regions. He/She may also manage contractor staff to support international submissions.
Partner with local and regional regulatory colleagues to identify regulatory CMC requirements and expectations for Intercon markets.
Ensure Procedural Documents and Job Aids reflect evolving Health Authority requirements.
Anticipate and communicate possible regulatory paradigm shifts
Serve as primary interface with international strategy leads and/or regional leads to set CMC priorities during development.
Interface with in-country colleagues, connecting GRS-CMC and Global Product Development and Supply organization, to prioritize life-cycle management submissions.
Lead cross functions initiatives aimed at streamlining business processes and ways of working.
Monitor and communicate changes in regulatory requirements to key stakeholders.
Minimum 10 years pharmaceutical or related experience, Regulatory experience preferred, but not required.
Knowledge of CMC regulatory requirements during development and post-approval phases.
Ability to develop/maintain strong working relationships, participate on and/or lead multifunctional teams, handle and prioritize multiple projects and work independently.
Ability to interact with CMC technical experts regarding CMC issued during development and throughout the life cycle of the product.
Ability to identify, communicate and resolve routine/complex issues.
Ability to identify trends & changes in affecting the regulatory landscape and recommend changes to internal business processes, where necessary.
Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
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.
Physical presence at the BMS worksite or physical presence in the field is an essential job function of this role which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and enhances the Company culture.
To protect the safety of our workforce, customers, patients and communities, the policy of the Company requires all employees and workers in the U.S. and Puerto Rico to be fully vaccinated against COVID-19, unless they have received an exception based on an approved request for a medical or religious reasonable accommodation. Therefore, all BMS applicants seeking a role located in the U.S. and Puerto Rico must confirm that they have already received or are willing to receive the full COVID-19 vaccination by their start date as a qualification of the role and condition of employment. This requirement is subject to state and local law restrictions and may not be applicable to employees working in certain jurisdictions such as Montana. This requirement is also subject to discussions with collective bargaining representatives in the U.S.
Our company is committed to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an approval of accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application or if you are applying to a role based in the U.S. or Puerto Rico and you believe that you are unable to receive a COVID-19 vaccine due to a medical condition or sincerely held religious belief, during or any part of the recruitment process, please direct your inquiries to firstname.lastname@example.org. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.
BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.
Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.