layiq

/la·yiq/adjective

worthy; deserving; fitting; suitable.

A role, opportunity, or path that merits attention, time, and pursuit.

Associate Director, Global Regulatory Sciences - CMC at Bristol Myers Squibb | LAYIQ

Minimum BA/BS Degree
8+ years Pharmaceutical industry experience – prefer knowledge of small molecules, biotechnology or cell therapy products, including multi-disciplined experience, 5+ years CMC regulatory strategy
Knowledge of CMC regulatory requirements for advanced therapies and/or small molecules, biologics, and cell therapy during development and post-approval as applicable
Knowledge of pharmaceutical development, including advanced therapies and/ or small molecules, biologic, and cell therapy upstream and downstream processes, analytical methods, and small molecule or biologic/device combination, cell therapy products as applicable
Expertise in the biological, cell therapy and/or small molecule modalities, drug development process and analytical methods, preferred as applicable
Inter-dependent partnering skills, team-oriented and ability to influence outcomes
Experience in successfully leading teams; ability to broadly represent the regulatory functions on project teams within BMS and across alliance
Must be able to innovate, analyze and solve problems with minimal supervision and attention to details
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
Looks for opportunities for continuous improvement
Strong team player, using both internal and external resources to execute regulatory activities and working across organizational, functional, and geographic boundaries to achieve company goals
Communicates opinions, facts and thoughts with clarity, transparency, and honesty
Experience applying project management techniques within teams. Experience in effectively managing meetings
Experience with developing and documenting regulatory strategies in coordination with clinical plans and marketing objectives
Demonstrated ability to facilitate issue resolution and conflict management, to negotiate and influence others; ability to drive quality decision making, to organize and prioritize tasks and negotiate
Demonstrated ability to coordinate global activities
Ability to identify, communicate and resolve complex issues
Prepare and manage filings and ensure thoroughness, accuracy and timeliness
Ability to interpret global regulations and guidance
Strong oral and written skills
Proficient with electronic systems
This position may require up to 5% of travel
We hire for skills and capabilities, not just credentials – if this role excites you, but doesn’t perfectly match your resume, we encourage you to apply anyway.

Benefits:

Subject to the terms and conditions of the applicable plans then in effect, you may be eligible to participate in our comprehensive benefit plans – including wellbeing support, retirement and financial protection benefits, and insurance offerings (medical, dental, vision, life and disability).
U.S.-based exempt employees are eligible for Flexible Time Off (FTO), which provides paid time off without a set accrual limit, subject to manager approval, along with 11 paid company holidays each year.
Non-exempt employees, RayzeBio employees, and employees located in Puerto Rico receive 160 hours of paid vacation annually for new hires (subject to manager approval), 11 paid company holidays, and 3 optional holidays.
Depending on eligibility, employees may also have access to additional time-off benefits, including paid sick leave, up to two paid volunteer days per year, summer hours flexibility, and leaves of absence for medical, personal, parental, caregiver, bereavement, or military needs. Eligible employees also enjoy an annual Global Shutdown between Christmas Day and New Year's Day.
U.S.-based job seekers can explore full benefit offerings at https://careers.bms.com/benefits
How We Work
Where you work matters – because collaboration, innovation and patient impact happen in many settings. Our roles are structured across four work models: site-essential, site-by-design, field-based and remote-by-design. The model assigned to this role is based on its core responsibilities. Learn more at https://careers.bms.com/ways-of-working.
Supporting People with Disabilities
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-accessibility to access our complete Equal Employment Opportunity statement.
Candidate Rights
BMS will consider qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.
For roles based in Los Angeles County only: If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/
Data Protection
We will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at https://careers.bms.com/fraud-protection .
Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
If this posting is missing required information required by local law or incorrect, contact BMS at TAEnablement@bms.com with the Job Title and Requisition number. Do not send application-related inquiries to this email. To check your application status, please login to your Candidate Home Account.
R1604324 : Associate Director, Global Regulatory Sciences - CMC

Associate Director, Global Regulatory Sciences - CMC

Employer job description

Qualifications

Compensation Overview:

Benefits:

About this listing