Director, Regulatory Strategist, GRS, Immunology

We are a recruiting company EasyHiring looking for candidates for the position of Director, Regulatory Strategist, GRS, Immunology in Richboro, PA to work in Lawrence Township PA for our partners.

Working with Us
Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at our company 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 rich in diversity. Take your career farther than you thought possible.

We 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.

Expected Areas of Competence

• Develop and lead Global and US Regulatory activities for a Development Team (s), leveraging primarily external resources for operation activities, and internal resources for strategic and HA engagement.
• Collaborate and influence internal BMS expertise and external regulatory resources to assure regulatory issues are addressed in development plans
• Provide leadership to resolve critical regulatory project issues, bring the appropriate regualtory experts together as needed
• Establish sound regulatory advice/position on key development issues, and communicate same to DTL and other team stakeholders
• Develop registration strategy for a product, and translate that into operational deliverables for execution by external and specific internal resources
• Develop alternative plans for achieving regulatory objectives with associated risks and mitigation strategies
• Provide strategic regulatory input to key development documents and study reports, including Clinical protocols, clinical reports/summary documents, nonclinical reports/summary documents Nonclinical and clinical summary documents, Analysis Plans and DMC Charters
• Provide strategic regulatory input on the target product profile, CCDS, and country-specific label
• Create an asset specific Global and US HA interactions strategy, integrating regional/local objectives and strategies and lead effective interactions with HA globally, partner with regional / local liaisons to execute interactions
• Formulate US regulatory strategy and filings
• Formulate integrated global submission plan for simultaneous filings and take accountability for translating that into operational plans to be delivered by external vendors
• Approval of regulatory documents
• Ensure documents and regulatory dossier are compiled according to appropriate standard and guidelines

Behaviors

• Translates broad strategies into specific objectives and action plans that can be effectively executed by external partners.
• Sets challenging, but regulatory achievable objectives, comfortable taking risk in the regulatory setting
• Generates alternative regulatory strategies and plans, and assesses benefits and risks.
• Develops contingency plans and meets challenges necessary to execute business and action plans. Ensures these plans are feasible using external resources.
• Creates a unified and seamless team using both internal and external resources to execute regulatory strategy
• Communicates opinions, facts and thoughts with clarity, transparency and honesty
• Seeks multiple perspectives and listens openly to others’ points of views.
• Enables and demonstrates the courage to speak up on issues and risks as well as on the good news.
• Demonstrates ownership of results within (and beyond) area of responsibility.
• Sets clear and high expectations and holds self and others accountable for decisions and results achieved.
• Develops and applies unique ideas and new methods to achieve higher performance and excellence.
• Works across organizational, functional and geographic boundaries to achieve company goals.
• Creates an environment that encourages continuous improvement, innovation and appropriate risk taking.
• Demonstrates resilience and perseverance.

Degree / Experience Requirements

• Solid scientific background, Ph.D., M.D., PharmD, MS, or BS
• Significant experience in regulatory affairs (e.g. > 4-7 years)

Qualifications

• Proven success in delivering effective global regulatory strategies in coordination with clinical plans and marketing objectives leading to successful registration.
• Excellent in communicating regulatory strategy, issues, and risks in written and verbal format
• Experience leading cross functional matrix teams
• Demonstrated ability to break down complex, scientific issue and communicating regulatory implications
• Proven success in negotiating regulatory objectives with HA

The starting compensation for this job is a range from $173,000 - $257,000, 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 where the job is performed. Final, individual compensation will be decided based on demonstrated experience. Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit our BMS Career Site. Benefit offerings are subject to the terms and conditions of the applicable plans then in effect and may include the following: Medical, pharmacy, dental and vision care. Wellbeing support such as the BMS Living Life Better program and employee assistance programs (EAP). Financial well-being resources and a 401(K). Financial protection benefits such as short- and long-term disability, life insurance, supplemental health insurance, business travel protection and survivor support. Work-life programs include paid national holidays and optional holidays, Global Shutdown days between Christmas and New Year’s holiday, up to 120 hours of paid vacation, up to two (2) paid days to volunteer, sick time off, and summer hours flexibility. Parental, caregiver, bereavement, and military leave. Family care services such as adoption and surrogacy reimbursement, fertility/infertility benefits, support for traveling mothers, and child, elder and pet care resources. Other perks like tuition reimbursement and a recognition program

#LI-Hybrid

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.

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-accessibilityto access our complete Equal Employment Opportunity statement.

BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.

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.

Job Type: Full-time

Work Location: On the road

Salary : $173,000 - $257,000