Regulatory Associate

2 days ago

Sydney, New South Wales, Australia Clinigen Full time

Clinigen, a rapidly growing global specialty pharmaceutical services business, is seeking a detail-oriented and motivated Regulatory Associate to join our dynamic team.
In this role, you will play a vital part in supporting the regulatory activities across Clinigen's portfolio, helping ensure that our products meet the highest standards of compliance and regulation.Your primary responsibilities will include assisting in the preparation and submission of regulatory documents, maintaining up-to-date records, and providing support for regulatory inquiries.
You will work closely with the Regulatory Affairs team and other departments to facilitate the timely delivery of projects and ensure that all regulatory submissions are accurate and complete.This is an excellent opportunity for someone looking to grow their career in regulatory affairs and make a significant impact within a globally recognized organization.Requirements Bachelor's degree in Life Sciences, Pharmaceutical Sciences, or a related field 4+ years of experience in regulatory affairs or a related field within the pharmaceutical or healthcare industry Demonstrated experience in a regulatory role servicing Australia and New Zealand.
Knowledge of TGA and Medsafe, other APAC regulatory knowledge is desirable.
eCTD publishing experience is desirable Strong attention to detail and ability to manage multiple tasks effectively Excellent written and verbal communication skills Proficient in Microsoft Office Suite and ability to learn new software efficiently Team player with a collaborative approach and strong interpersonal skills Ability to work in a fast-paced environment and adapt to changing priorities If you are passionate about regulatory affairs and eager to contribute to the success of our products, we encourage you to apply
BenefitsIn return, we can offer: Competitive remuneration Annual performance bonus Flexible working arrangements Ongoing support for professional development Paid parental leave Onsite parking

  • Regulatory Affairs Associate

    6 days 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

    2 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 Associate

    4 hours ago

    Sydney, New South Wales, Australia Clinigen Full time

    OverviewClinigen, a rapidly growing global specialty pharmaceutical services business, is seeking a detail-oriented and motivated Regulatory Associate to join our dynamic team. In this role, you will play a vital part in supporting the regulatory activities across Clinigen's portfolio, helping ensure that our products meet the highest standards of compliance...

  • Regulatory Affairs Associate

    1 week ago

    Sydney, New South Wales, Australia Roche Full time

    Join to apply for the Regulatory Affairs Associate | ANZ role at RocheJoin to apply for the Regulatory Affairs Associate | ANZ role at RocheAt Roche you can show up as yourself, embraced for the unique qualities you bring.Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who...

  • Regulatory Affairs Associate

    4 weeks ago

    Sydney, New South Wales, Australia Roche Full time

    Join to apply for the Regulatory Affairs Associate | ANZ role at RocheJoin to apply for the Regulatory Affairs Associate | ANZ role at RocheAt Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who...

  • Regulatory Affairs Associate

    4 weeks ago

    Sydney, New South Wales, Australia Roche Full time

    Join to apply for the Regulatory Affairs Associate | ANZ role at RocheJoin to apply for the Regulatory Affairs Associate | ANZ role at RocheAt Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who...

  • Regulatory Affairs Associate

    3 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 Associate

    3 days ago

    Sydney, New South Wales, Australia Viatris Full time

    Regulatory Affairs Associate – ViatrisLocation: Sydney Head Office, Millers Point, NSW; Employment: Full Time, Fixed Term (9 months)At Viatris, we see healthcare not as it is but as it should be.We act courageously and are uniquely positioned to be a source of stability in a world of evolving healthcare needs.Viatris empowers people worldwide to live...

  • Regulatory Affairs Associate

    4 weeks ago

    Sydney, New South Wales, Australia 3801 Upjohn Australia Pty Ltd. Full time

    Regulatory Affairs Associate page is loadedRegulatory Affairs AssociateApply locations Sydney, New South Wales, Australia time type Full time posted on Posted 8 Days Ago job requisition id R5661486 Upjohn Australia Pty Ltd.At VIATRIS, we see healthcare not as it is but as it should be. We act courageously and are uniquely positioned to be a source of...

  • Regulatory Affairs Associate

    1 week 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...