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 .
The Regulatory Affairs Manager reports to the Associate Director Regulatory Affairs. They are responsible to lead, plan and execute timely registrations of new BMS assets, life-cycle management as well as regulatory compliance of BMS products. Our ideal candidate would have significant industry experience (8+ years) in the Australian Pharmaceutical Regulatory Environment and thrive in a collaborative team environment.

Responsibilities

• Provide informed and strategic regulatory guidance to assure prompt, successful approval of applications by Health Authorities.
• Develop and implement regulatory strategies by pre-empting potential problems in regulatory packages and taking effective steps to deal with them.
• Drive regulatory process to ensure appropriate and timely filing and approval of new products (NCE’s, line extensions), product variations (inclusive of changes in CMC, labelling) and renewals, in accordance with business objectives.
• Ensure compliance with marketing authorization and with BMS governance requirements.
• Ensure compliance with BMS system and process requirements. Identify opportunities for improvement.
• Communicate and escalate promptly, where required to Manager and relevant stakeholders. Maintain a strong sense of urgency to a high level of quality, focusing on the ultimate business objectives.
• Establish strong working relationships with key stakeholders (Health Authorities, customers, team and business colleagues within BMS).
• Actively solicit input from stakeholders to achieve registration objectives, time lines and business goals.
• Anticipate and identify trends in regulatory environment that may impact on the business.
• Partner with other BMS functional groups by providing regulatory advice and critical problem solving, e.g.: Global Pharmacovigilance, Global Supply Chain, Clinical Research and Quality.
• Promote best practices by sharing regulatory experiences.
• Manage GRS and organisational projects, as required by business needs.
• Manage or mentor other staff, as required by business needs.
• Maintain high awareness of regulatory environment, and changes. Participate in various industry/Health Authority meetings to help shape and influence the regulatory environment in the country.
• 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 Company procedures.

Qualifications, experience and competencies

• Tertiary qualification in medicine/pharmacy/life science with a preference for a higher degree
• Significant (8+ years) relevant pharmaceutical experience in the country regulatory environment. Additional experience in related fields will be well regarded
• Demonstrated experience in leading people of different functions in managing issues or projects. Demonstrated ability to engage others to achieve favourable results.
• Demonstrated ability to negotiate with people of various internal and external functions, including Health Authorities.
• Demonstrated ability to project manage, plan, problem solve and deliver results to timelines.
• Demonstrated ability to work with ambiguity and to thrive in a changing environment.
• Excellent knowledge of Australia/New Zealand regulatory processes, regulations and guidelines. Knowledge of European and/or US regulatory processes will be well regarded.
• Sound understanding of the drug development process from discovery to marketing.
• Excellent oral, written and communication skills in English.

LinkedIn-Hybrid

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.

• Provide informed and strategic regulatory guidance to assure prompt, successful approval of applications by Health Authorities.
• Develop and implement regulatory strategies by pre-empting potential problems in regulatory packages and taking effective steps to deal with them.
• Drive regulatory process to ensure appropriate and timely filing and approval of new products (NCE’s, line extensions), product variations (inclusive of changes in CMC, labelling) and renewals, in accordance with business objectives.
• Ensure compliance with marketing authorization and with BMS governance requirements.
• Ensure compliance with BMS system and process requirements. Identify opportunities for improvement.
• Communicate and escalate promptly, where required to Manager and relevant stakeholders. Maintain a strong sense of urgency to a high level of quality, focusing on the ultimate business objectives.
• Establish strong working relationships with key stakeholders (Health Authorities, customers, team and business colleagues within BMS).
• Actively solicit input from stakeholders to achieve registration objectives, time lines and business goals.
• Anticipate and identify trends in regulatory environment that may impact on the business.
• Partner with other BMS functional groups by providing regulatory advice and critical problem solving, e.g.: Global Pharmacovigilance, Global Supply Chain, Clinical Research and Quality.
• Promote best practices by sharing regulatory experiences.
• Manage GRS and organisational projects, as required by business needs.
• Manage or mentor other staff, as required by business needs.
• Maintain high awareness of regulatory environment, and changes. Participate in various industry/Health Authority meetings to help shape and influence the regulatory environment in the country.
• 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 Company procedures