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Senior Regulatory Affairs Specialist

1 month ago

Ryde, Australia Merck Gruppe - MSD Sharp & Dohme Full time

Job Description

Senior Regulatory Affairs Specialist – Animal Health

  • Looking for a different challenge as a Senior Regulatory Affairs Specialist whereby you can utilise your skills?
  • Permanent Full-time position with competitive remuneration and benefits
  • Location: Sydney, Macquarie Park
  • Hybrid, work from home and office environment, with 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
  • Join a trusted Global leading Animal Health organisation

The primary responsibility of the Senior Regulatory Affairs Specialist is to drive the development, importation, and registration of new products and to ensure internal and external regulatory compliance for the entire product range.

Of critical importance to the successful execution of this role is management of new product development and registration projects and for conducting routine regulatory operations to ensure compliance.

The Senior Regulatory Affairs Specialist sits within the Animal Health organisation and reports to the Regulatory Affairs Manager.

What You Will Do

Responsibilities include, however not limited to:

Regulatory Project Management

  • Registration of new products – Review, compile and submit registration dossiers and data packages for agreed key projects, within timeframes agreed with manager and in accordance with government, industry and corporate requirements to maintain regulatory compliance and facilitate product supply.
  • Product stewardship for existing portfolio, including providing regulatory support for additional claims, variations.
  • Provide regulatory support to global and local stakeholders to conduct research trials for new products or label extensions for existing products.
  • Identify and communicate risks to approvals or timelines agreed as part of project planning.
  • Propose options to address any technical / regulatory concerns as applicable.
  • Support the development of the regulatory strategy for new technologies in Australia. This will include liaising with Regulatory authorities in Australia with the view of gaining market access for these new technologies.

Regulatory Compliance and Technical Support

  • Provide regulatory and technical advice as requested to other parts of the organization to ensure that correct and compliant information is used in decision making and strategy development.
  • Support of the Change Control process.
  • Maintain relevant Permits and Licences.
  • Ensure that our company's products comply with the regulatory and legal requirements set by the local regulatory authorities.
  • Ensure all advertising, promotional and educational/technical materials that are related to products marketed comply with applicable local laws and regulations and consistent with all corporate and our company Animal Health's policies and standards, and reflects our company's Code of Conduct.
  • Participate in PQC investigations and recall actions as required.
  • Maintain all documentation in accordance with Company and relevant quality standards.

Training

  • Complete all training requirements, in accordance with company and relevant quality standards requirements.
  • Attend relevant training courses as the opportunity presents.
  • Ensure good housekeeping in the work area in accordance with company and relevant quality standards.

Pharmacovigilance

  • Follow global and local procedures to ensure suspected adverse events are timely reported and meet the local legislative requirements.
  • Ensure that all PV obligations relating to both internal local/global company processes AND Australian/ NZ regulatory requirements are met.
  • For Specialists with PV back-up responsibility:
  • Maintain a current local and Global PV training status (to National PV team level) - as directed by the local DPOC
  • Assist with entry of local PV cases into PV Works as directed by your manager and in accordance with local and global PV procedures and timelines

What You Must have

  • Graduate or Post-Graduate degree in relevant biological science
  • Solid prior experience in regulatory affairs
  • Knowledge of relevant Australian Regulatory Systems
  • Highly developed skills in negotiating, influencing, leadership with excellent communication and organizational skills
  • Understanding of quality systems
  • Ability to analyse data. Logical and analytical approach to problem solving
  • Ability to work well with other departments in a team setting. Self-starter with initiative who works well with minimal supervision
  • Ability to work under pressure to meet deadlines and to make sound decisions on a day-to-day basis concerning regulatory affairs

What You Can Expect

  • Work autonomously whilst being supported, encouraged and being part of a trusted Global leading Animal Health organisation
  • Exposure to upskill and develop in your role
  • Flexibility and opening doors to other opportunities and skillsets
  • Joining a collaborative team of likeminded 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:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Hybrid

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

05/26/2025

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

Requisition ID:R346058

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