Senior Regulatory Affairs Specialist

1w1 week ago

Bristol Myers Squibb

Mulgrave, AU · Full-time · A$130,000 – A$170,000

About this role

Working at Bristol Myers Squibb means engaging in challenging, meaningful, life-changing work every day. As Senior Regulatory Affairs Specialist, take responsibility for all regulatory activities related to assigned products in Australia and New Zealand. Support the Associate Director, Global Regulatory Sciences Australia and New Zealand.

Plan and execute timely product variations while ensuring regulatory compliance of BMS products supplied in Australia and New Zealand. Apply knowledge of registration processes and regulatory considerations for life-cycle management events. Drive key regulatory processes in line with GRS and business objectives.

Manage interactions with Health Authorities and cultivate strong working relationships. Track changes in regulatory requirements and communicate regulatory intelligence promptly to local GRS colleagues, global teams, and stakeholders. Ensure compliance with marketing authorization, BMS governance, and system requirements.

Thrive alongside high-achieving teams through opportunities uncommon in scale and scope. Bristol Myers Squibb offers balance and flexibility with a wide variety of benefits, services, and programs. Pursue goals both at work and in personal lives while transforming patient lives and advancing your career.

Requirements

Tertiary qualification in medicine, pharmacy, or life science
Knowledge of registration processes and regulatory considerations for life-cycle management events
Understanding of product variations including CMC and labelling changes
Familiarity with GMP clearances, variations, and renewals
Experience managing regulatory compliance and health authority interactions
Ability to track and communicate regulatory intelligence effectively

Responsibilities

Ensure appropriate and timely filing and approval of product variations including changes in CMC and labelling
Archive regulatory files and documentation and maintain 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
Manage interactions with Health Authorities and cultivate strong working relationships
Track changes in regulatory requirements and communicate regulatory intelligence to stakeholders
Maintain knowledge of regulatory environment and participate in industry initiatives as needed
Promptly report adverse events or quality product complaints within 24 hours per BMS procedures