Senior Regulatory Affairs Associate

Job Description

Senior Regulatory Affairs Associate

• Looking for an exciting opportunity as a Senior Regulatory Affairs 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

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

What You Will Do

Responsibilities include, however not limited to:

Regulatory Project Management

• Review, compile and submit complex 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 (including evaluating regulatory probability of success) the technical and scientific requirements of more complex regulatory applications during the pre-submission, submission, and evaluation process, ensuring timely and high-quality justifications or consultations with the Health Authorities or responses to questions from the Health Authorities in line with global guidance.

• Ensure cost effective project management and coordination of work with others (including leading teams), 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 on complex issues 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 Teams, with regular and prompt attendance, completion of designated action items within agreed timeframes and appropriate contribution to discussions.  Proactively recognize and communicate important PLP issues to others outside the team.  Develop and maintain effective working relationships with all members of Product Lifecycle Planning team.

• Actively collect, analyse and disseminate regulatory intelligence and other information and formulate strategies for best practices for a changing regulatory environment.

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

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

What You Must have

• Pharmacy degree or life sciences degree, with at least four years’ experience in Regulatory Affairs for prescription products.

Competencies and Skills include:

• Collaboration & Partnering - thinking and acting beyond one's silo - bridging boundaries across teams, functions, liaisons, geographies, external stakeholders and customers

• Project Management - the ability to organise work efforts by prioritising tasks, using resources optimally, establishing appropriate deadlines and ensuring on-time delivery of tasks, deliverables and/or project results

• Productive Communication - planning and delivering ideas and information to others in an impactful manner.  Demonstrating the ability to listen to others, and to speak and write clearly and concisely

• Strategic thinking - visualise the way forward, identify opportunities that add value to the work, to the business and to our customers

• Problem solving - gathering and analysing data and effectively responding to new, complex or problematic situations; creating solutions that drive value for our company and our customers, incorporating innovative approaches where relevant

• Regulatory & Compliance Management

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 a collaborative team of like-minded individuals

We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.

Current Employees apply HERE

Current Contingent Workers apply HERE

Search Firm Representatives Please Read Carefully 
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.  No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. 

Employee Status:

Regular

Relocation:

No relocation

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Not Applicable

Shift:

Valid Driving License:

Hazardous Material(s):

Requisition ID:R290396