- Permanent full-time hybrid position based in Sydney
- Lead regulatory submissions and lifecycle management across ANZ
- Join a global pharma with award-winning culture & benefits
Our client, a global pharmaceutical innovator consistently recognised as a Great Place to Work for the past eight years, is seeking a Regulatory Affairs Manager to join their high-performing team. This is a rare opportunity to step into a stand-alone role where you will take ownership of regulatory strategy, compliance, and submissions, supporting both Australian and global business objectives.
As Regulatory Affairs Manager, you will oversee product registrations, lifecycle management, and interactions with local health authorities. This role is ideal for a professional who combines a strategic mindset with the ability to manage complex situations, influence internal and global stakeholders, and ensure compliance across rare disease, small molecule, and biologics portfolios.
Your Key Responsibilities:
- Lead the preparation, submission, and maintenance of regulatory applications to local health authorities.
- Develop regulatory strategies for new and existing products, including rare diseases.
- Anticipate and manage risks by providing clear communication and forward planning across multiple departments.
- Collaborate with marketing, medical, quality, and global regulatory colleagues to ensure timely approvals and compliance.
- Review and approve promotional materials and ensure adherence to Medicines Australia’s Code of Conduct.
- Represent the affiliate in global forums and contribute to company-wide SOPs and compliance processes.
- Provide training and guidance on regulatory standards to internal stakeholders.
- Bachelor’s degree in Pharmacy, Life Sciences, Chemistry, or Regulatory Affairs.
- Minimum of 5 years of experience in Regulatory Affairs within pharmaceutical companies.
- Strategic thinker with proven ability to manage risk, communicate effectively, and influence diverse stakeholders.
- Resilient professional who can hold their own in discussions, navigate complex situations, and bring structure to fast-moving environments.
- Flexible and collaborative
With a strong patient-first culture and deep community connections through charity work, employees are proud to be part of an organisation that truly makes a difference.
This is an hybrid position based in Sydney. For a confidential conversation about this role, please call Grace Bitodi on 0294312540 or email on gbitodi@onqrecruitment.com.au.
