Senior Manager, Regulatory Operations

Bristol Myers Squibb • New Brunswick, NJ

2d

About The Position

Working with Us Challenging. Meaningful. Life-changing. Those aren’t 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. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving 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: careers.bms.com/working-with-us. Key Responsibilities 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) People Manager • Lead, motivate, mentor, and coaches 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 Qualifications & Experience 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 Required Competencies Ability to work independently and within team matrix environments • Ability to manage teams associated with individual aspects of responsibilities; direct people management and project management aspects • Thorough knowledge of worldwide regulatory GMP requirements and a working knowledge of Food and Drug Administration (FDA) & European Union (EU) GMP requirements • In depth knowledge of Quality Management Systems with an emphasis on change control principles and the applicability of restrictions in the release process for changes that require health authority approval • Ability to ensure objective critique of dossier content and health authority query / response content to ensure that compliance is maintained • Must be able to prioritize, organize and manage multiple tasks to tight deadlines • Ability to assess the right balance between the business implications, technical considerations and quality decisions • People Management (set objectives, coach, prioritize team members work) BMSBL 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.

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
• Strong technical knowledge of the regulatory landscape and requirements; ability to translate regulatory requirements into action
• Ability to work independently and within team matrix environments
• Ability to manage teams associated with individual aspects of responsibilities; direct people management and project management aspects
• Thorough knowledge of worldwide regulatory GMP requirements and a working knowledge of Food and Drug Administration (FDA) & European Union (EU) GMP requirements
• In depth knowledge of Quality Management Systems with an emphasis on change control principles and the applicability of restrictions in the release process for changes that require health authority approval
• Ability to ensure objective critique of dossier content and health authority query / response content to ensure that compliance is maintained
• Must be able to prioritize, organize and manage multiple tasks to tight deadlines
• Ability to assess the right balance between the business implications, technical considerations and quality decisions
• People Management (set objectives, coach, prioritize team members work)

Nice To Haves

• Project Management skills are desired

Responsibilities

• 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 coaches 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

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. All global employees full and part-time who are actively employed at and paid directly by BMS at the end of the calendar year are eligible to take advantage of the Global Shutdown.
• Eligibility Disclosure: The summer hours program is for United States (U.S.) office-based employees due to the unique nature of their work. Summer hours are generally not available for field sales and manufacturing operations and may also be limited for the capability centers. Employees in remote-by-design or lab-based roles may be eligible for summer hours, depending on the nature of their work, and should discuss eligibility with their manager. Employees covered under a collective bargaining agreement should consult that document to determine if they are eligible. Contractors, leased workers and other service providers are not eligible to participate in the program.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level