Company

MsdSee more

addressAddressMacquarie Park, NSW
type Form of workFull time
CategoryLegal

Job description

Regulatory Affairs Specialist

  • Looking for a different challenge as a Regulatory Affairs Specialistwhereby you can still utilise your skills?
  • Permanent Full-time position with competitive renumeration and benefits
  • Ideally based from Sydney Australia, also open to NZ located applicants
  • 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 Regulatory Affairs Specialist plays a crucial role in ensuring internal and external regulatory compliance for the manufacture, importation, and supply of the entire animal health product range in Australia and New Zealand. The pharmaceutical industry in Australia and New Zealand is highly regulated and competitive, making it essential for the company's success to navigate regulatory processes efficiently and effectively.

    The Regulatory Affairs Specialist sits within the Regulatory Affairs Operations organization and reports to Regulatory Affairs Operations Team Leader.

    What You Will Do

    Responsibilities include, however not limited to:

  • Regulatory Submissions: The Regulatory Affairs Specialist is responsible for submitting applications to regulatory authorities (e.g., APVMA, ACVM, DAFF) to maintain registrations in compliance with product changes and regulatory requirements.
  • Compliance Management: Taking ownership of regulatory processes is another key responsibility. This includes managing changes in artwork, approving marketing materials, ensuring regulatory reporting and maintenance of permits and licenses, and adhering to internal policies and legislative requirements.
  • Change Control Support: The Specialist provides regulatory input for change control processes across our company’s Animal Health's manufacturing and quality network. This involves contributing to decision making and strategy development by offering regulatory and technical advice to other parts of the organization.
  • Pharmacovigilance Support (if applicable): If the Specialist has pharmacovigilance responsibilities, they must maintain current pharmacovigilance training and assist in processing local pharmacovigilance cases in compliance with company and regulatory requirements.
  • What You Must have:

    Education and Experience:

  • Graduate or Post-Graduate degree in a relevant biological science field
  • Solid amount of experience in a related industry
  • Experience in the animal health industry or pharmaceutical manufacturing is highly beneficial
  • Regulatory Knowledge

    Familiarity with the Australian and New Zealand Regulatory Systems (e.g., APVMA, DAFF, ACVM).

    Leadership and Communication

  • Strong negotiation and influencing skills.
  • Excellent communication (both written and verbal) and organizational skills.
  • Ability to work collaboratively in a team setting.
  • Analytical and Problem-Solving Skills

    Ability to analyse data with a logical and analytical approach to problem-solving.

    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:

    Relocation:

    VISA Sponsorship:

    Travel Requirements:

    Flexible Work Arrangements:

    Shift:

    Valid Driving License:

    Hazardous Material(s):

    Requisition ID:R282210

    Refer code: 1856251. Msd - The previous day - 2024-03-23 18:21

    Msd

    Macquarie Park, NSW
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