Associate Director, GxP Regulatory Intelligence

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Principle Objective of Position:

The Associate Director, GxP Regulatory Intelligence, plays a key role in supporting and contributing to the execution of the GxP External Engagement strategy as a member of the External Engagement team. This includes: 1) Ensuring that BMS is recognized by regulatory authorities and industry peers as a thought leader in the areas of innovation, science, technology, quality and compliance 2) Promoting an organizational risk-based mind-set through early actions on issues of potential impact to operations, supply, or quality compliance and 3) Promoting transparency in information sharing and excellence in quality through the monitoring of internal and external factors for potential impact to operations and products, including those from emerging regulations, guidance, evolving expectations and quality issues in the GxP space.

The Associate Director, GxP Regulatory Intelligence will, in collaboration with the GxP External Engagement team, help drive the strategy for External Engagement and surveill and influence external developments in the GxPs and will execute compliance and intelligence programs in a matrixed organization. This role will interact and collaborate extensively with external parties (e.g., industry peers and regulatory authorities) and will provide a supportive role to the internal-focused teams throughout the BMS network.

Reporting Structure:

This position is part of the Global Quality Organization and will report to the Director, GxP External Engagement.

Major Duties and Responsibilities

The Associate Director, GxP External Engagement, will apply strong leadership and interpersonal relationship skills to accomplish the following responsibilities that include, but are not limited to:

External Engagement (60%):

• Actively participate in industry conferences and Trade Association meetings and working groups to develop relationships and build intelligence on upcoming regulatory changes and emerging compliance expectations that impact Quality, Compliance & Operations functions. Communicate learnings through established processes and relationships across the network. Drive BMS awareness of and engagement in key organizations.
• Supporting the Director, GxP External Engagement, effectively communicate the outcomes of external engagement across the organization, and ensure a closed loop mechanism to drive company action and impact where needed.
• Timely identify and assess emerging topics/expectations to define the company´s strategy and involvement.
• Benchmark best practices in the industry to continuously improve internal processes and systems for development and manufacturing.
• This position requires travel approximately 60% of the time to conferences, Trade Association meetings and internal sites to drive the BMS strategy.
  

Compliance/Quality Surveillance (40%):

• As part of the GxP External Engagement team, support the routine compliance surveillance activities to detect, monitor, collate and communicate global compliance trends which could impact GXP operations.
• Identify, assess, and communicate emerging surveillance of regulatory and compliance landscape through the timely authorship and review of FLASH Reports and Regulatory Surveillance Yammer postings.
• Enhance communications with the Quality Councils, to ensure proactive engagement and continuous improvement.
• Support data-driven insights into compliance performance and opportunities for improvement.
• Advance compliance expertise at BMS by providing education, knowledge sharing and other modes of learning.

Required Knowledge/Skills/Qualifications

Education:

• Bachelor's degree in pharmaceutical sciences, regulatory affairs, engineering, biology, or other related discipline or equivalent combination of education and experience
• FDA or other Health Authority experience required

Experience/Knowledge:

• Experience within regulatory agencies or the Bio/Pharmaceutical Industry, including leadership experience in Clinical Studies, Quality, Manufacturing, Regulatory and/or Product Development.
• Significant understanding and track record in dealing with international regulation and policy development processes of major regulatory agencies.
• Understanding of technical areas related to pharmaceutical and/or biological manufacturing, clinical study, regulatory and or quality control/quality assurance processes.
• Comprehensive understanding of one of more GxP areas and willingness to expand knowledge into other areas.
• Have working knowledge of Regulatory Intelligence tools and stay up to date with GxP Regulatory news regarding key competitors and regulatory agencies.

Skills/Competencies:

• Demonstrated ability to work in a matrixed organization with a range of technically, culturally, and geographically diverse teams and to influence areas not under direct control to achieve objectives and effectively communicate challenging goals and objectives.
• Strong communication, collaboration, negotiation, problem solving and interpersonal skills. Has a proven track record of working across regulatory/industry boundaries to find common solutions and drive positive impact and benefits for patients.
• Ability to communicate and represent BMS at key conferences and in key Trade Organizations and working groups.
• Ability to communicate and collaborate with employees and management at all levels and through various formats (e.g. presentations, written proposals, reports, correspondence, lead meetings, face-to-face dialogue, etc.).
• Pragmatic approach with demonstrated ability to make sound, risk-based decisions.
• Excellent oral and written communication skills.
• Ability to be flexible and adapt quickly to the changing needs of the organization.
• Demonstrated high degree of independence with effective presentation and interpersonal skills to ensure a team-oriented approach.

Travel Required

Role is Remote by Design with a minimum of 60% travel anticipated per year

The starting compensation for this job is a range from $141,000 - $178,000, plus incentive cash and stock opportunities (based on eligibility). The starting pay rate takes into account characteristics of the job, such as required skills and the geographic location where work is performed. Final, individual compensation is decided commensurate with demonstrated experience. For more on benefits, please visit our BMS Careers Site. Eligibility for specific benefits listed therein may vary based on job and location.

#LI-Remote

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
Physical presence at the BMS worksite or physical presence in the field is a necessary job function of this role, which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and it enhances the Company culture.

COVID-19 Information
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.

BMS is dedicated to ensuring that people with disabilities can perform complex functions through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an accommodation prior to accepting a job offer. If you require reasonable accommodation 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 will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

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