Regulatory Project Management
Regulatory Project Management
Employer Active
Job Alert
You will be updated with latest job alerts via email
Share
Job Alert
You will be updated with latest job alerts via email
Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
Working with Us
Challenging. Meaningful. Lifechanging. Those arent words that are usually associated with a job. But working at Bristol Myers Squibb 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. Youll get the chance to grow and thrive through opportunities uncommon in scale and scope alongside highachieving teams. Take your career farther than you thought possible.
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. Read more: a Bristol Myers Squibb company is a dynamic biotechnology company headquartered in San Diego CA. The company is focused on improving survival of people with cancer by harnessing the power of targeted radioisotopes. RayzeBio is developing innovative drugs against targets of solid tumors. Led by a successful and experienced entrepreneurial team RayzeBio aims to be the global leader in radiopharmaceuticals.
Senior Manager of Regulatory Project Management will plan execute and oversee regulatory submissions and projects and manage crossfunctional relationships to achieve ontime completion of submissions. This position will report to Head of Regulatory Affairs.
Responsibilities
Essential duties and responsibilities include the following. Other duties may be assigned.
Project Planning and Execution of Regulatory Submissions (e.g. IND CTA NDA MAA IMPD simplified dossiers briefing packages RFI exploratory IND)
Develop and maintain project timelines and schedules
Define project scope objectives and deliverables
Create and manage project plans including resource allocation and task assignments
Monitor project progress identify potential issues and escalate to stakeholders as needed
Crossfunctional Communication
Communicate project status and progress to internal and external stakeholders
Collaborate with Program Management to ensure regulatory timelines are in alignment with company program timelines and expectations.
Manage expectations and address concerns of stakeholders
Collaborate with crossfunctional teams to ensure project success
Documentation and Reporting
Prepare and maintain regulatory submission trackers
Document project milestones and report progress against team department and corporate goals
Provide regular updates on project progress and status to management and crossfunctional teams
Basic Qualifications
Bachelors degree or higher
A minimum of 7 years of experience in regulatory project management
Handson experience with NDA filing is a must
Oncology Regulatory PM experience
Preferred Qualifications
Experience with all phases of clinical development (eIND IND CTA MAA dossiers)
Demonstrable proficiency in project timeline and Gannt chart software (eg OnePager MS Project Smartsheet) MS Office (eg Outlook Word PowerPoint Excel and Teams) Adobe Acrobat Pro and video conferencing
Radiopharmaceutical experience
Skills and Qualifications
Demonstrable record of strong communication and teamwork in a crossfunctional industry environment
Highly organized with the ability to multitask and handle pressure well
Meticulous with detail and precision
Ability to think through a project or task of diverse complexity and execute independently from beginning to end
Excellent communication skills (both written and verbal)
Excellent interpersonal skills (ability to build and maintain strong crossfunctional relationships)
Knowledge of relevant regulations guidances and standards
Should be assertive proactive professional and confident
Excellent professional ethics and integrity
Flexibility to adapt in a crossfunctional and dynamic environment
The starting compensation for this jobis a range from $ 164846 to $199.800 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 subject to the terms and conditions of the applicable plans then in effectand may include the following: Medical pharmacy dental and vision care. Wellbeing supportsuch asthe BMS Living Life Better program and employee assistance programs (EAP). Financial wellbeing resources and a 401(K). Financial protection benefits such as short and longterm disability life insurance supplemental health insurance business travel protection and survivor programs include paid national holidays and optional holidays Global Shutdown Days between Christmas and New Years holiday up to 120 hours of paid vacation up to two (2) paid days to volunteer sick time off and summer hours 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.
#RayzeBio
If you come across a role that intrigues you but doesnt 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 Lifechanging 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 a supportive culture promoting global participation 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.
Onsite Protocol
BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes siteessential sitebydesign fieldbased and remotebydesign jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:
Siteessential roles require 100% of shifts onsite at your assigned facility. Sitebydesign roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles onsite presence is considered an essential job function and is critical to collaboration innovation productivity and a positive Company culture. For fieldbased and remotebydesign roles the ability to physically travel to visit customers patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.
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 . Visit to access our complete Equal Employment Opportunity statement.
BMS cares about your wellbeing and the wellbeing of our staff customers patients and communities. As a result the Company strongly recommends that all employees be fully vaccinated for Covid19 and keep up to date with Covid19 boosters.
BMS will consider for employment qualified applicants with arrest and conviction records pursuant to applicable laws in your area.
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: data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
Employment Type
Full-Time
