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AUS-Melbourne 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.

**Regulatory Affairs Specialist**

BMS is seeking a pharmaceutical professional with a desire to, or experience in, work with Regulatory Affairs. Regulatory Affairs play a pivotal role in enabling access for patients to access vital medicines in Australia and New Zealand. The scope of the role includes supporting a diverse range of biological therapies across various disease areas such as Oncology, Haematology Rheumatology 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 Regulatory Affairs Specialist will be an important 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:

+ Assist in the appropriate and timely filing and approval of products NCEs, line extension), product variations (inclusive of changes in CMC, labelling).

+ Assist in providing informed and accurate regulatory guidance in quality, safety, compliance and clinical trial matters.

+ 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.

+ Grow knowledge and track changes in regulatory requirements sharing learnings promptly and effectively

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

**Essential Skills & Qualifications:**

You may be an established Regulatory Affairs professional with industry experience or an industry professional with a desire to establish a career in Regulatory Affairs

In addition you will demonstrate:

+ A passion for Regulatory Affairs, focus, energy and desire to make a difference.

+ A learning mindset

+ Knowledge of Australia/New Zealand pharmaceutical industry, preferably of 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

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:** R1538598

**Updated:** 2021-04-03 02:30:06.315 UTC

**Location:** Melbourne,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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ID: 18580062 - Save Job
Category: Jobs : Science Jobs
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AUS-Melbourne Regulatory Affairs Specialist PayPal


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