Regulatory Affairs

5 days ago

Sydney, New South Wales, Australia beBeeCompliance Full time $120,000 - $150,000
About This Role

This role presents an exciting opportunity to contribute to the success of our organization by ensuring compliance with key regulatory requirements. As a Regulatory Affairs & Compliance Manager, you will play a pivotal part in facilitating interactions with government agencies, departments, and regulators, while contributing to good governance across the organization.

The ideal candidate will possess a strong understanding of legal principles and have significant experience working within highly regulated environments. They should be able to design, implement, and continuously improve governance models that support compliance with relevant regulatory obligations.

A key aspect of this role is maintaining accurate and up-to-date compliance registers in alignment with our enterprise-wide compliance framework. You will also work closely with stakeholders to ensure oversight of all regulatory matters and establish effective relationships with external regulators.

  • Main Responsibilities:
  • - Design, implement, and continuously improve a governance model for the organization that supports compliance with relevant regulatory obligations.
  • - Maintain an accurate and up-to-date compliance register in alignment with our enterprise-wide compliance framework.
  • - Work closely with stakeholders to ensure oversight of all regulatory matters.
  • - Establish and maintain effective and collaborative working relationships with external regulators.
  • - Perform the secretariat function of various research committees.

To succeed in this role, you will need to demonstrate strong analytical and problem-solving skills, as well as excellent communication and interpersonal skills. You should be able to work effectively as part of a team and independently, with minimal supervision.

About Our Organization

We are committed to investing in our people and providing a supportive work environment that encourages professional growth and development. If you are passionate about regulatory affairs and compliance, and want to make a meaningful contribution to our organization's success, we encourage you to apply for this exciting opportunity.

Key Requirements
  • Essential Qualifications:
  • - Law degree
  • - Significant experience working within highly regulated environments
  • - Sound understanding of relevant regulatory requirements
  • Desirable Skills:
  • - Experience in writing accurate and concise minutes
  • - Ability to provide high-level advice to stakeholders
  • - Strong analytical and problem-solving skills

What We Offer

  • Flexible Work Environment:
  • - Hybrid work arrangement
  • Excellent Benefits:
  • - Competitive salary and benefits package
  • Opportunities for Growth and Development:
  • - Ongoing training and professional development opportunities

  • Regulatory Affairs Associate

    5 hours ago

    Sydney, New South Wales, Australia Novo Nordisk Full time

    Regulatory Affairs AssociateCategory:Reg Affairs & Safety PharmacovigilanceLocation:North Sydney, New South Wales, AURegulatory Affairs AssociateClinical, Medical & Regulatory (CMR)Sydney, AustraliaAre you passionate about regulatory compliance and committed to ensuring the safety of life-changing pharmaceutical products? If you thrive in a dynamic and...

  • Regulatory Affairs Specialist

    5 days ago

    Sydney, New South Wales, Australia beBeeRegulatory Full time $80,000 - $120,000

    Job SummaryWe are seeking a highly skilled Regulatory Affairs Specialist to join our team. This role will be responsible for supporting regulatory affairs activities for assigned products in Australia and New Zealand.Main Responsibilities:Support Regulatory Activities: Ensure compliance with all relevant regulations while assisting in developing strategies...

  • Regulatory Affairs Associate

    1 week ago

    Sydney, New South Wales, Australia Novo Nordisk, Inc. Full time $90,000 - $120,000 per year

    Regulatory Affairs AssociateCategory: Reg Affairs & Safety PharmacovigilanceLocation:North Sydney, New South Wales, AURegulatory Affairs AssociateClinical, Medical & Regulatory (CMR)Sydney, AustraliaAre you passionate about regulatory compliance and committed to ensuring the safety of life-changing pharmaceutical products? If you thrive in a dynamic and...

  • Regulatory Affairs Associate

    4 days ago

    Sydney, New South Wales, Australia Novo Nordisk Full time

    Regulatory Affairs Associate**Category**:Reg Affairs & Safety Pharmacovigilance**Location**:North Sydney, New South Wales, AU**Regulatory Affairs Associate****Clinical, Medical & Regulatory (CMR)****Sydney, Australia**- Are you passionate about regulatory compliance and committed to ensuring the safety of life-changing pharmaceutical products? If you thrive...

  • Regulatory Affairs Associate

    5 days ago

    Sydney, New South Wales, Australia Novo Nordisk Full time

    Regulatory Affairs AssociateClinical, Medical & Regulatory (CMR)Sydney, Australia Are you passionate about regulatory compliance and committed to ensuring the safety of life-changing pharmaceutical products?If you thrive in a dynamic and collaborative environment, we invite you to join our Clinical, Medical, and Regulatory (CMR) Oceania team as a Regulatory...

  • Regulatory Affairs

    5 days ago

    Sydney, New South Wales, Australia Bio-Rad Laboratories Full time

    Overview: A key member of the Regulatory Affairs Function, accountable for providing regulatory affairs knowledge and support the business meeting its objectives, as well as regional RA activities.Delivering product pre market approval within the timeframe, post-market vigilance and maintenance of all related regulatory activities obtain necessary regulatory...

  • Regulatory Affairs Specialist

    2 weeks ago

    Sydney, New South Wales, Australia beBeeRegulatoryAffairs Full time $90,000 - $110,000

    Regulatory Affairs SpecialistWe are seeking a highly motivated and detail-oriented Regulatory Affairs Specialist to support our organization in delivering regulatory submissions on time.Key Responsibilities:Deliver regulatory submissions within required timeframes;Ensure databases and systems are accurate and current by drafting, updating, reviewing and...

  • Regulatory Affairs Associate

    2 days ago

    Sydney, New South Wales, Australia Pfizer Full time

    Why Patients Need YouThis is a great opportunity to become part of a dedicated and successful Regulatory Department and to help us make a meaningful difference to the lives of patients in Australia and New Zealand. Our Team is talented, collaborative, diverse and made up of experienced regulatory professionals who always strive for the best outcomes for...

  • Regulatory Affairs Specialist

    1 week ago

    Sydney, New South Wales, Australia beBeeRegulatoryAffairs Full time $98,765 - $123,456

    Job Title: Regulatory Affairs ProfessionalWe are seeking a highly skilled regulatory affairs professional to fill this key position in Sydney. As a crucial member of our regulatory affairs team, you will be responsible for ensuring the continuity of supply via life cycle maintenance activities for our existing portfolio and supporting the registration of new...

  • Regulatory Affairs Associate

    2 weeks ago

    Sydney, New South Wales, Australia Novo Nordisk Full time

    Regulatory Affairs AssociateClinical, Medical & Regulatory (CMR)Sydney, AustraliaYour new roleAs a Regulatory Affairs Associate, you will support regulatory processes for products in Australia and New Zealand, ensuring compliance while promoting development and registration. Your role involves managing document submissions, engaging with regulatory...