Bristol Myers Squibb

Senior Manager, Regulatory Operations

Bristol Myers Squibb

full-time

Posted on:

Location Type: Office

Location: New Brunswick • New Jersey • United States

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Salary

💰 $125,340 - $151,884 per year

Job Level

Senior

About the role

  • Working as part of a team dealing with global market registrations and providing regulatory guidance, direction and support to all External Manufacturing groups
  • Supporting regulatory activities for new products and technology transfers to include strategy and timeline development, specification setting and testing standard updates
  • Maintains strong communication and working relationships with all departments, contract manufacturing organizations, and global personnel such as global regulatory, global testing standard and compendial organizations
  • Coordination of External Manufacturing (EXM) dossier review and approval management process (Module 2 and 3) and prepares registration documents as required
  • Coordination and review of regulatory renewals, Good Manufacturing Practices (GMP) renewals and annual report submissions
  • Ensures that appropriate documentation is maintained to ensure compliance of products manufacture at contract manufacturing organizations with the regulatory filings
  • Participating in other Quality Assurance (QA) supporting activities as required (e.g. internal audits, site regulatory inspections, Annual Product Quality Reviews (APQR’s), quality risk management)
  • Lead, motivate, mentor, and coach team members with ongoing effective performance feedback and provide developmental opportunities to meet Department and company goals/objective ensuring continuous improvement and a high performing team

Requirements

  • Minimum BSc in chemistry or related disciplines
  • Knowledge and operational experience in a GMP environment
  • Knowledge of the structure, content and requirements relating to the Common Technical Document (CTD)
  • Sound experience of regulatory processes and Health Authority (HA) requirements/guidance’s for FDA, EU and global markets
  • Regulatory Starting Material (RSM), Intermediate, Active Pharmaceutical Ingredients (API) and Drug Product (DP) Pharmaceutical experience or Biologics Drug Substance (DS) and DP preferred
  • Strong knowledge of compliance requirements
  • Project Management skills are desired
  • Strong technical knowledge of the regulatory landscape and requirements; ability to translate regulatory requirements into action.
Benefits
  • Health Coverage: Medical, pharmacy, dental, and vision care.
  • Wellbeing Support: Programs such as BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP).
  • Financial Well-being and Protection: 401(k) plan, short- and long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support.
  • Work-life benefits include: Paid Time Off US Exempt Employees: flexible time off (unlimited, with manager approval), 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico or Rayzebio employees)
  • Phoenix, AZ, Puerto Rico and Rayzebio Exempt, Non-Exempt, Hourly Employees: 160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays.
  • Based on eligibility*, additional time off for employees may include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs and an annual Global Shutdown between Christmas and New Years Day.
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
GMPCommon Technical Document (CTD)regulatory processesHealth Authority (HA) requirementsRegulatory Starting Material (RSM)Active Pharmaceutical Ingredients (API)Drug Product (DP)Biologics Drug Substance (DS)project managementquality risk management
Soft Skills
communicationteam leadershipmentoringcoachingperformance feedbackdevelopmental opportunitiescontinuous improvementrelationship managementcollaborationmotivation
Certifications
BSc in chemistry