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AUS-Mulgrave Senior Regulatory Affairs Specialist Job at PayPal

At Bristol Myers Squibb, we are inspired by a single vision – transforming patients’ lives through science. In oncology, hematology, immunology and cardiovascular disease – and one of the most diverse and promising pipelines in the industry – each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.

**Dynamic Regulatory Affairs Role**

Bristol Myers Squibb (BMS) is seeking a Regulatory Affairs Specialist to join our high performing team. This is a key role in planning, supporting 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 recognised as one of Australias fastest growing pharmaceutical companies, 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:

+ Manage appropriate and timely filing and approval of products line extensions, product variations (inclusive of changes in CMC, labelling).

+ 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.

+ Establish strong working relationships with key stakeholders (Health Authorities, customers and business colleagues within BMS).

+ Maintenance of regulatory databases.

+ 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 regulatory requirements sharing knowledge promptly and effectively

+ Maintain a strong sense of urgency to a high level of quality.

**Essential Skills & Qualifications:**

You should be an established Regulatory Affairs professional with industry experience.

In addition you will demonstrate:

+ A passion for regulatory affairs, focus, energy and desire to make a difference.

+ A learning mindset.

+ 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.

+ Knowledge of how pharmaceutical products are marketed and the regulatory impact on promotional literature and activities.

+ Minimum tertiary qualification in medicine/pharmacy/life science. Relevant post-graduate qualifications would be well regarded.

+ 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 high performing Regulatory Affairs team

+ Work with cross-functional teams, gain a broad view of the business and grow business acumen.

Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

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.

**Company:** Bristol Myers Squibb

**Req Number:** R1538883

**Updated:** 2021-04-03 02:30:06.316 UTC

**Location:** Mulgrave,Australia

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.
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Category: Jobs : Science Jobs
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AUS-Mulgrave Senior Regulatory Affairs Specialist PayPal


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