MSD Regulatory Affairs Assistant/Associate 

Australia, New South Wales 

593319421

Job Description

Looking for an exciting opportunityas Regulatory Affairs Assistant/Associate with an Innovator Research-intensive biopharmaceutical Company?

• Permanent Full-time position with competitive renumeration and benefits

• Location: Sydney, Australia

• Hybrid, work from home and office environment, joining a dedicated and welcoming team

• Join a growing, yet already successful market

• Upskill and growth in an area you’re passionate about , whilst being fully supported and encouraged

Regulatory Project Management

• Review, compile and submit registration dossiers and data packages, within timeframes agreed with manager and in accordance with government, industry and corporate requirements to maintain regulatory compliance and facilitate product supply.

• Manage and support the technical and scientific requirements of a broad range of regulatory applications during the pre-submission, submission, and evaluation process, proposing timely and high-quality justifications with the Health Authorities or responses to questions from the Health Authorities in line with global guidance.

• Ensure effective management of own projects and coordination of work with others, compliance to global and local policies, and effective and timely communication of new or amended registered details to stakeholders within the company.

Regulatory and Technical Support

• Provide regulatory and technical advice to other parts of the organization to ensure that correct and compliant information is used in decision making and strategy development.

Develop and Maintain Key Relationships

• Effectively participate in designated Product Life-Cycle Planning (PLP) Teams, with regular and prompt attendance, completion of designated action items within agreed timeframes and appropriate. contribution to discussions. Communicate important PLP issues to others outside the team. Develop and maintain effective working relationships with all members of PLP team.

• Actively collect, analyse and disseminate regulatory intelligence and other information in accordance with commercial interests.

• Effectively participate in Regulatory team discussions, bringing forward issues for consideration and contributing to the development of solutions.

• Foster professional relationships with individuals within TGA and Medsafe who would be responsible for evaluating our company submissions.

Teamwork

• Effectively participate in RA Team joint projects or Department projects.

• Help with other team projects as required.

• Personal and Professional Development.

• Undertake internal and external training to develop and maintain a broad and current knowledge of Regulatory Affairs, and knowledge of relevant disease and therapeutic areas.

• Agree with manager and implement a relevant and achievable Development Plan to ensure ongoing development of personal and professional skills.

Key Communications:

1.Therapeutic Goods Administration and Medsafe.These Agencies are responsible for registration of pharmaceuticals and vaccines in Australia and New Zealand, respectively.

4.Regulatory Affairs Department- The position works with Regulatory Affairs Associates, Senior Regulatory Affairs Associates, and Administration Assistant as assigned to ensure consistency in applying regulatory and company guidelines.

5.Further Communication:Liaise formally each week with Regulatory Affairs Assistants and/or Regulatory Affairs Manager regarding product issues and workload priorities.

6.– The position communicates and discusses the progress of regulatory submissions.

To be successful in this role, you will require:

• Pharmacy degree or life sciences degree

• Strong communication and technical writing skills

• Project management skills

What You Can Expect

• Work autonomously whilst being supported, encouraged and being part of a trusted Global leading organisation

• Exposure to upskill and develop in your role

• Flexibility and opening doors to other opportunities and skillsets

• Joining acollaborativeteam oflikeminded individuals

Current Contingent Workers apply

*A job posting is effective until 11:59:59PM on the dayBEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the dayBEFOREthe job posting end date.

A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.