Senior Director GRS-CMC Small Molecule

Profile

Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis.

Join us and make a difference. We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development. Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results.

Functional Area Description

The GRS-CMC organization provides regulatory expertise related to CMC activities through all stages of a products lifecycle. Members of the organization develop global regulatory CMC strategies and partners with key stakeholders to execute the strategies in alignment with business priorities. The team also perform regulatory assessments for manufacturing changes, provides guidance on regulatory expectations for medical devices, oversees BSE program & provides compliance documents to support Health Authority submissions. The team also supports Medical Information to build/maintain database to address external questions regarding drug products.

Position Summary / Objective

Provides oversight of multiple development and/or life-cycle management projects of varying priorities and complexities. Partners with others on the GRS-CMC Leadership team to prioritize departmental initiatives and streamline business process aligned with regulatory expectations. Represents Regulatory-CMC on cross functional teams, governance committees, and due diligence/in-licensing projects. Represents BMS at health authority meetings. Serve as a credible, respected spokesperson in discussions with key stakeholders and Health Authorities. Develops & communicates strategic direction based on global regulatory guidelines and experience. Seeks opportunities for external regulatory engagement for themselves and/or members of their team.

Position Responsibilities

In addition to the general objectives, the GRS-CMC Senior Director is responsible for the following:


Develop & communicate strategic direction based on global regulatory guidelines and experience.

Prepare or oversee preparation of CMC submissions while ensuring thoroughness, completeness, and timeliness.

Review submissions from CMC managers for clarity of both strategic and technical content.

Utilize electronic systems for dossier creation, review, and tracking.

Manage and actively support growth and development of direct reports.

Actively participates in leadership or department meetings.


Degree Requirements

Minimum BA/BS Degree

Experience Requirements


Minimum 10 years pharmaceutical or related experience, prefer multidiscipline, and 8 years regulatory CMC experience.

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 process development and analytical issues.

Ability to identify, communicate and resolve routine/complex issues.

Ability to identify trends & changes in regulations affecting the regulatory landscape and recommend changes in internal business processes, where necessary.


Key Competency Requirements

Strong oral and written skills

Prior management skills preferred

Travel Required

Some travel is required

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 the resources to pursue their goals, both at work and in their personal lives.

Bristol-Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

Company info

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