Job Information
Bristol Myers Squibb Senior Regulatory Affairs Specialist in Mulgrave, Australia
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 rich in diversity. 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 .
Dynamic Regulatory Affairs Role
Bristol Myers Squibb (BMS) is seeking a Senior Regulatory Affairs Specialist to join our high performing team, within the Global Regulatory Sciences function.
This is a key role in planning and executing business appropriate registrations and life-cycle management as well as regulatory compliance of BMS products supplied in Australia & New Zealand. The scope of the role includes supporting a diverse range of therapies across various disease areas such as Oncology, Haematology, Rheumatology, Immunosciences and Cardiovascular.
BMS is focused on delivering innovative medicines to treat serious unmet medical needs. The Senior Regulatory Affairs Specialist will be an integral member of the Regulatory Affairs team, helping BMS achieve its objectives, namely driving drug access for patients and business success.
Role Responsibilities:
Within a collaborative, learning environment:
Provide informed, accurate regulatory guidance in quality, safety, compliance and clinical trial matters.
Develop and recommend regulatory strategies in consultation with stakeholders, and Regulatory Affairs team.
Manage appropriate and timely filing and approval of products line extensions, product variations (inclusive of changes in CMC, labelling).
Maintenance of regulatory documentation and databases.
Establish strong working relationships with key stakeholders (Health Authorities, and Global partners within BMS).
Grow self & peers by sharing regulatory experiences and promoting best practices.
Communicate clearly and persuasively to internal stakeholders (regional and global teams, business partners) as well as Health Authorities.
Maintain knowledge and track changes in the regulatory environment sharing knowledge promptly and effectively
Qualifications, experience and competencies:
You should be an established Regulatory Affairs professional with industry experience.
In addition, you will demonstrate:
Minimum tertiary qualification in medicine/pharmacy/life science. Relevant post-graduate qualifications would be well regarded.
Excellent knowledge of Australia/New Zealand regulatory processes, regulations and guidelines.
Ability to engage and influence others to achieve favourable outcomes.
Demonstrated ability to negotiate with people of various internal and external functions, including Health Authorities.
Demonstrated ability to deliver high quality results within tight deadlines.
A passion for regulatory affairs, focus, energy and desire to make a difference.
A learning mindset.
Excellent written and verbal communication skills
The Rewards
Help patients access vital medicines to treat serious disease
Work for an organisation focused on developing people, culture, wellbeing and the healthcare environment
Be part of a supportive high performing Regulatory Affairs team
Work with cross-functional teams, gain a broad view of the business and grow business acumen.
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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 an inclusive culture, promoting diversity 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 a diverse 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.
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/ (https://careers.bms.com/eeo-accessibility) eeo-accessibility to access our complete Equal Employment Opportunity statement.
BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.
BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.
Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
Company: Bristol-Myers Squibb
Req Number: R1579469
Updated: 2024-04-26 01:25:11.927 UTC
Location: Mulgrave-AUS
Bristol Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.