Associate Director, Global Regulatory CMC
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.
Responsible for the development of the CMC regulatory strategy for submissions. These submissions include IND/CTA, NDA, CTD and MAA regulatory filings.
Collaborate with other relevant line functions to prepare and review CMC submission documents, registration dossiers, and responses to health authorities.
Responsible for the regulatory evaluation of CMC change controls.
Responsible for the management of CMC activities related to specific developmental or commercial compounds.
Represent Regulatory CMC on CMC development/commercial and Regulatory Affairs teams.
In addition take on leadership role in the CMC development/commercial teams. Interact with regulatory agencies and represent CMC at regulatory agency meetings.
Qualification/ Skills / Knowledge Required
BS/BA degree in Scientific Discipline (Masters or higher preferred) with 7-9 years in the pharmaceutical industry or in CRO, including 4-6 years’ CMC regulatory experience.
Must have experience with CMC regulatory documents (NDA, MAA, CTD, annual reports, supplements, responses and IND/CTAs)
Knowledge of FDA, EMEA and ICH guidelines
Have a solution-oriented approach to problem solving
Experience in developing CMC regulatory strategy
Expertise in either the drug development process or post approval activities
Ability to work on complex projects and within cross-functional teams
Excellent grammar and communication skills, both written and oral
Prior supervisor or project management experience
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 email@example.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.
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