Senior Regulatory Manager, Quality
FullscriptSalary not specified
Full Time
Senior (5 to 8 years)
Not SpecifiedCompensation
Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level
Full TimeJob Type
UnknownVisa
Pharmaceuticals, BiotechnologyIndustries
Requirements
- Degree or equivalent in healthcare related field
- 3+ years of direct regulatory experience with developing knowledge of US and/or EU procedures
- Ability to work independently and at pace in a global matrix environment and effectively prioritize multiple projects
- Strong sense of personal accountability for delivery; able to lead through influence and building alignment with stakeholders to deliver projects to plan
- Continuous improvement mindset
- Strategic problem solver
- Good communication and negotiation skills
- Good interpersonal skills
Responsibilities
- Partner with the Global Regulatory Lead (GRL) and wider Global Regulatory Sub-Team (GRST) to deliver and execute the optimal regulatory strategy for assigned asset(s)
- Co-lead GRST meetings in alignment with the GRS Culture Playbook to ensure high quality discussions & decisions; diligent follow-up with sub-team members to uphold accountabilities and drive decision making
- Develop and maintain the asset’s global regulatory book of work and Global Submission Plan including: Tracking key regulatory milestones as defined by the GRST (e.g., health authority meetings, post-approval commitments, annual reports, etc.); Liaise cross-functionally to generate periodic internal milestone reports; Maintaining global submission plans including oversight of the interdependencies across regions for timely execution aligned with the asset’s priorities; Communicate status and timeline changes
- Provide operational support to the GRL on strategic global regulatory documents including the Regulatory Strategy Plan
- Co-ordinate the rapid response process to ensure quality and timely responses to health authority queries globally
- Review prior health authority queries to guide response development
- Represent the Global Regulatory Lead in team as needed
- Partner with the US Regulatory Lead to: Co-ordinate preparation of regulatory components for US submissions and author assigned m1 documents; Support and co-ordinate preparations for FDA meetings; Provide additional support e.g., precedent analysis
- Lead or represent RPM on GRS and enterprise process initiatives to drive a culture of continuous improvement and operational excellence
- Engage with customers to enhance RPM support
Skills
Key technologies and capabilities for this role
Questions & Answers
Common questions about this position
What benefits does Bristol Myers Squibb offer?
Bristol Myers Squibb offers a wide variety of competitive benefits, services, and programs that provide employees with resources to pursue their goals both at work and in their personal lives.
Is this a remote or flexible position?
Bristol Myers Squibb recognizes the importance of balance and flexibility in the work environment, though specific details for this role are not provided.
What qualifications are required for the Senior Manager I, RPM role?
A degree or equivalent in a healthcare-related field is required, along with 3+ years of direct relevant experience.
What is the company culture like at Bristol Myers Squibb?
The culture emphasizes challenging, meaningful, and life-changing work with high-achieving teams, opportunities for growth, and a focus on balance and flexibility.
What experience makes a strong candidate for this role?
Candidates with 3+ years of direct regulatory experience, particularly in partnering with Global Regulatory Leads and Sub-Teams, and skills in managing regulatory strategies and submissions, will stand out.
Bristol-Myers Squibb
Develops and delivers biopharmaceutical medicines
About Bristol-Myers Squibb
Bristol Myers Squibb (BMS) develops and delivers medicines aimed at treating serious diseases, focusing on areas like cancer, autoimmune diseases, and heart conditions. The company conducts extensive research and development to create new drugs, which are sold after receiving regulatory approval. BMS also produces generic drugs, offering affordable alternatives that meet the same quality standards as their branded counterparts. What sets BMS apart from competitors is its dual focus on both innovative and generic medicines, enhancing access to healthcare. The company's goal is to improve patient outcomes while maintaining a commitment to sustainability and corporate responsibility.
New York City, New YorkHeadquarters
1887Year Founded
$33,706.1MTotal Funding
IPOCompany Stage
Biotechnology, HealthcareIndustries
10,001+Employees