Regulatory Affairs Operations Team Lead

1 month ago

Macquarie Park, Australia MSD Australia Full time

Job Description

Regulatory Affairs Operations Team Lead ANZ

  • Looking for a role within an Animal Health business renowned for innovation, growth and diversity?

  • Are you seeking the opportunity to develop your career? 

  • Join a diverse workforce that values collaboration

The Animal Health sector is a highly regulated and very competitive market. Success is often dependent on getting new products into the market quickly.  This requires a high level of coordination between customers, sales and marketing and other internal stakeholders.

The primary responsibility of the Regulatory Affairs Operations Team Lead, ANZ is the execution and management of the operational requirements of the Regulatory Affairs Department. These activities include product variations, licences, permits, renewals, re-registrations, SDS, SOPs, labelling and packaging.

The Regulatory Operations Team may also undertake regulatory review of advertising and promotional materials as part of the Advertising and Promotional Review process.

What You Will Do

In this role you will lead a small team to:

  • Identify, initiate, and complete projects to support the maintenance of the existing approved portfolio of products.  

  • Manage, triage and track variations which impact our existing portfolio to ensure these are assessed and submitted in accordance with expected timeframes to maintain business continuity.

  • Contribute to the change control process and global platforms for managing regulatory status, data and information.

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

  • Control and monitor all licenses, permits, registrations to ensure compliance with local legislation to facilitate continuous supply of products. 

  • Manage and maintain a consistent approach to all Regulatory company records and documentation and ensuring this approach is in accordance with Company and relevant quality standards.

  • Maintain the operating plan for the sale of restricted veterinary medicines (NZ).

  • Participate in PQC investigations and recall actions as required.

  • Manage the product labelling and artwork approval process and database to ensure all product labels are in alignment with regulatory approvals.

  • Ensure all advertising, promotional and educational/technical materials comply with applicable local laws and regulations and are consistent with all corporate policies and standards, and reflects our Code of Conduct.

  • 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 processes and regulatory requirements are met.

  • Manage EHS procedures.

What You Must have

  • Tertiary qualifications in Veterinary or an equivalent Life Science discipline.

  • Experience in a regulatory environment in Animal Health.

  • Experience dealing with one or both of the relevant ANZ regulators.

  • Demonstrable leadership and collaboration skills. (Previous staff management skills ideal but not essential).

  • The ability to absorb, analyse and disseminate technical and scientific related information.

  • A logical approach to problem solving and ability to solve complex problems.

  • Understanding of quality systems.

  • Initiative, and the ability to work well with minimal supervision.

  • Ability to work under pressure to meet deadlines.

  • A sound, pragmatic and prompt decision making capability and confidence when dealing with key stakeholders.

What You Can Expect

  • Work autonomously whilst being supported and encouraged within a trusted, leading, Global Animal Health organisation.

  • Exposure to upskill and develop in your role.

  • Be part of 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:

No relocation

VISA Sponsorship:

No

Travel Requirements:

10%

Flexible Work Arrangements:

Not Applicable

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

06/17/2024

*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.

Job Posting End Date:06/17/2024

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.

Requisition ID:R294198

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