Senior Regulatory Affairs Specialist

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.

Functional Area Description

• Responsible for all regulatory activities related to assigned products in the role as Senior Regulatory Affairs Specialist.
• Support Associate Director, Global Regulatory Sciences Australia and New Zealand.

Position Summary / Objective

• To plan and execute timely product variations as well as regulatory compliance of BMS products supplied in Australia & New Zealand, in consultation with Regulatory Affairs Managers, Associate Director and Director.
• To apply knowledge of registration processes and regulatory considerations for life-cycle management events.
• To drive key regulatory processes in line with GRS and business objectives. 

Position Responsibilities

• Ensure appropriate and timely filing and approval of product variations (inclusive of changes in CMC, labelling) in accordance with business objectives.
• Responsible for archiving regulatory files and documentation, and maintenance of regulatory databases.
• Ensure all GMP Clearances are valid by timely filing of variations and renewals
• Manage product artwork development according to BMS processes and health authority requirements
• Ensure compliance with marketing authorization and with BMS governance requirements.
• Ensure compliance with BMS system and process requirements.  Identify opportunities for improvement.
• Manage interactions with Heath Authorities. Cultivate strong working relationships.
• Track changes in regulatory requirements that may impact on the business. Communicate regulatory intelligence promptly and effectively to local GRS colleagues, Global/Regional GRS, local management, marketing and medical teams.
• Maintain knowledge of regulatory environment, and changes.  Participate in industry and/or Health Authority initiatives (e.g. Medicines Australia working groups) on needs basis.
• Communicate issues early and escalate promptly, where required to RA Managers/Associate Director/Director and stakeholders. Maintain a strong sense of urgency with a high level of quality.
• Promptly report knowledge (initial or follow-up) of any adverse event or quality product complaints associated with a BMS product within 24 hours or one business day of becoming aware of the event, in accordance with BMS procedures.

Degree Requirements

• Required degrees, certifications, and/or licensure relevant to role
• Tertiary qualification in medicine/ pharmacy/ life science.
• Knowledge of pharmaceutical sciences/ chemistry/ biology/ medicine.
• Post graduate qualifications are well regarded.

Experience Requirements

• 3 years relevant prescription medicine experience, ideally in regulatory affairs.

Key Competency Requirements

• Demonstrated ability to negotiate with people of various internal and external functions, including global teams and Health Authorities.
• Demonstrated ability in planning and problem solving.
• Demonstrated ability to work with a range of technically and culturally diverse people and deliver high quality results within tight deadlines.
• Demonstrated ability to thrive in a changing environment.
• Knowledge of Australia/New Zealand regulatory processes, regulations and guidelines.
• Awareness of regulatory environment developments.
• Understanding of the drug development process from discovery to marketing.
• Working knowledge of quality, manufacturing & supply, clinical research, PV, pharmaceutical promotion.
• Excellent oral, written and communication skills in English.

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.

Uniquely Interesting Work, Life-changing 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.

On-site Protocol

BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:

Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design 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 field-based and remote-by-design 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.

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 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: 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 you believe that the job posting is missing information required by local law or incorrect in any way, please contact BMS at TAEnablement@bms.com. Please provide the Job Title and Requisition number so we can review. Communications related to your application should not be sent to this email and you will not receive a response. Inquiries related to the status of your application should be directed to Chat with Ripley.

R1601517 : Senior Regulatory Affairs Specialist