Regulatory Affairs Manager

2 weeks ago

Melbourne, Australia D'Arcy Weil Full time

Leading pharmaceutical company dedicated to improving global healthcare.
- Strong focus on research, innovation, and ethical practices.
- Diverse portfolio of life-changing medications addressing unmet medical needs

**D'Arcy Weil is proud to represent one of the leading pharmaceutical companies in the industry, known for its commitment to improving global healthcare by developing and delivering life-changing medications and therapies to patients worldwide. Their innovative approach to research and development, coupled with a strong emphasis on ethical practices, has established them as a trusted leader in the pharmaceutical sector.**

This role requires a highly experienced professional with a deep understanding of regulatory guidelines and requirements within the pharmaceutical industry, including Good Clinical Practice (GCP).

You will collaborate with cross-functional teams to ensure compliance throughout the product lifecycle and contribute to the successful launch of life-saving medications.

**Responsibilities**:

- Serve as the primary point of contact for regulatory authorities, leading communications, negotiations, and interactions related to regulatory submissions and product registrations.
- Stay updated on evolving regulations, guidelines, and industry trends, providing proactive insights and proposing strategies for compliance, including GCP.
- Collaborate with internal stakeholders to provide regulatory input on product development plans, labelling, packaging, and promotional materials, ensuring compliance with GCP.
- Conduct regulatory assessments for product changes, deviations, and non-conformances, ensuring timely reporting to regulatory authorities, in line with GCP requirements.
- Coordinate inspections, audits, and regulatory agency interactions, providing necessary documentation, responses, and follow-up actions, in adherence to GCP guidelines.
- Manage relationships with external regulatory consultants, legal advisors, and relevant parties to leverage expertise and ensure regulatory compliance, including GCP, across all operations.
- Support the preparation and execution of clinical trials, ensuring compliance with regulatory requirements and guidelines, including GCP.
- Train and educate internal teams on regulatory standards, procedures, and updates to ensure comprehensive compliance, including GCP.

**Qualifications**:

- Bachelor's degree in Pharmacy, Life Sciences, or a related field (advanced degree preferred).
- Minimum of 8 years of experience in regulatory affairs within the pharmaceutical industry, focusing on drug development and registration.
- Extensive knowledge of regional and international regulations and guidelines governing drug development and registration in Australia and relevant markets, including GCP.
- Proven track record of successful regulatory submissions and approvals in Australia and other applicable jurisdictions, while adhering to GCP.
- Strong understanding of pharmaceutical development processes, including clinical trials, manufacturing, and quality control, with expertise in GCP.
- Excellent analytical, problem-solving, and critical thinking skills.
- Exceptional written and verbal communication abilities, including negotiation and persuasion skills.
- Ability to thrive in a fast-paced, deadline-driven environment.
- Detail-oriented with exceptional organizational and project management skills.

As an employer, our client fosters a culture of excellence, innovation, and integrity. They recognize that their success is driven by the talent and dedication of their employees. With a commitment to personal and professional growth, they offer a stimulating and supportive work environment that empowers individuals to make a real impact in the field of healthcare.

  • Regulatory Affairs Specialist

    2 weeks ago

    Melbourne, Australia On Q Recruitment Full time

    Full time permanent position that can be based in Melbourne or Sydney - Hybrid working arrangement (2 days in the office and 3 days from home) - Be part of a fast growing global medical device company Wouldn't you want to utilise your strong medical device regulatory knowledge to be part of an ever fast growing global innovative company? - Full time...

  • Regulatory Affairs Manager

    2 weeks ago

    Melbourne, Victoria, Australia ClearCompany Full time

    Role Focus: Drive regulatory strategy and market development initiatives, influencing policy and industry engagement to support business objectives. Role Snapshot: Competitive salary with career progression in a leading energy provider. Develop and execute regulatory strategies to navigate evolving energy markets. Engage with policymakers, regulators,...

  • Regulatory Affairs Manager

    5 days ago

    Melbourne, Victoria, Australia ClearCompany Full time

    Role Focus: Drive regulatory strategy and market development initiatives, influencing policy and industry engagement to support business objectives.Role Snapshot:Competitive salary with career progression in a leading energy provider.Develop and execute regulatory strategies to navigate evolving energy markets.Engage with policymakers, regulators, and...

  • Scientific Affairs and Regulatory Expert

    19 hours ago

    Melbourne, Victoria, Australia Mondelez International Full time

    Company OverviewMondelēz International is a leading snacking company with a rich portfolio of brands, including Oreo, Cadbury Dairy Milk, and Toblerone. Our purpose is to empower people to snack right through offering the right snack, for the right moment, made in the right way.We have operations in more than 80 countries and employ approximately 91,000...

  • Director of Regulatory Affairs

    19 hours ago

    Melbourne, Victoria, Australia Gilead Sciences Full time

    At Gilead Sciences, we're committed to creating a healthier world for all people. As a global biopharmaceutical company, our mission requires collaboration, determination, and a relentless drive to make a difference.Our employees are our greatest asset as we work to achieve our bold ambitions. We're looking for passionate and ambitious individuals who share...

  • Regulatory Affairs Lead for Confectionery

    19 hours ago

    Melbourne, Victoria, Australia Mondelez International Full time

    About UsMondelēz International is a global leader in snacking, with iconic brands such as Oreo, Cadbury Dairy Milk, and Toblerone. Our mission is to provide consumers with the right snack, for the right moment, made in the right way. We operate in more than 80 countries and employ approximately 91,000 employees worldwide.Job SummaryThe Scientific Affairs...

  • Senior Regulatory Affairs Associate

    1 week ago

    Melbourne, Victoria, Australia Hengandhurst Full time

    Senior Regulatory Affairs Associate | multiple launches | MEL basedJoin to apply for the Senior Regulatory Affairs Associate | multiple launches | MEL based role at Heng & Hurst.Join a leading international biopharmaceutical company who is seeking an experienced Senior Regulatory Affairs Associate to support its continued growth and commitment to delivering...

  • Manager - Regulatory Affairs

    3 weeks ago

    Melbourne, Australia ProductLife Group Full time

    Specific Activities and Responsibilities: Must have expertise in Health Authority communications for Initial filings, LCM Activities and for variation submissions. Must have experience and thorough knowledge of the process of submissions at HA without missing any detail or deadline. Must be competent with the current changes and regulations from the...

  • Regulatory Affairs Associate

    1 week ago

    Melbourne, Australia u&u Recruitment Partners Full time

    About the company Our client is a ASX global pharmaceutical company recognised as the pioneers of treatments for patients with a variety of life-threatening disorders. About the role The Regulatory Affairs Associate will support the Regulatory Team in: Obtain regulatory approvals globally for designated product portfolio; Manage national regulatory...

  • Regulatory Affairs Director

    5 days ago

    Melbourne, Victoria, Australia BeathChapman Pte Ltd Full time

    About Us:BeathChapman Pte Ltd is a leading provider of trading solutions to clients around the world. We are committed to delivering exceptional service and expertise to our clients, and we are seeking a highly experienced Regulatory Affairs Director to join our team in Sydney.Main Responsibilities:Develop and implement effective regulatory compliance...

  • Senior Regulatory Affairs Director

    4 days ago

    Melbourne, Victoria, Australia Gilead Sciences, Inc. Full time

    Gilead Sciences, Inc. is a global biopharmaceutical company dedicated to creating life-changing therapies for patients with serious and often rare diseases.The Associate Director, Regulatory Affairs will play a key role in leading projects for the Regulatory Affairs team in the ANZ affiliate, working cross-functionally to ensure Gilead complies with the...

  • Scientific Affairs and Regulatory Affairs Lead – Chocolate, Australia

    2 days ago

    Melbourne, Victoria, Australia Mondelēz International Full time

    Job DescriptionAre You Ready to Make It Happen at Mondelēz International?Join our Mission to Lead the Future of Snacking. Make It Matter.Mondelēz International empowers people to snack right in over 150 countries around the world. We're leading the future of snacking with iconic global and local brands such as Oreo, Cadbury, Philadelphia, Pascall, The...

  • Regulatory Affairs Specialist

    5 days ago

    Melbourne, Victoria, Australia Bitfinex Full time

    At Bitfinex, we're shaping the future of digital asset trading. As a dynamic player in this space, we're seeking an experienced regulatory affairs specialist to join our team.About the RoleWe're looking for an individual with a deep understanding of legal and regulatory requirements pertaining to the crypto-asset industry in the Asia-Pacific region. The...

  • Scientific Affairs and Regulatory Affairs Lead – Chocolate, Australia

    21 hours ago

    Melbourne, Victoria, Australia Mondelez International Full time

    Mondelez International Scientific Affairs and Regulatory Affairs Lead – Chocolate, Australia & New Zealand in Melbourne, AustraliaJob DescriptionAre You Ready to Make It Happen at Mondelēz International?Join our Mission to Lead the Future of Snacking. Make It Matter.Mondelēz International empowers people to snack right in over 150 countries around the...

  • Manager - Pharmaceutical Regulatory Affairs

    2 weeks ago

    Melbourne, Australia Seqirus A CSL Company Full time

    A permanent, full-time role within our Global Regulatory Affairs group has become available. This role is for an experienced Regulatory professional and includes working on all CSL Seqirus manufactured products across the Asia Pacific region. This includes influenza vaccines and Products of National Significance (PNS) including snake/spider...

  • Regulatory Affairs Strategist

    5 days ago

    Melbourne, Victoria, Australia ClearCompany Full time

    Drive Regulatory Success in Energy MarketsIn this pivotal role as Regulatory Affairs Strategist, you will spearhead regulatory strategy and market development initiatives, influencing policy and industry engagement to support business objectives.About the Position:Create and execute comprehensive regulatory strategies to navigate evolving energy...

  • Senior Regulatory Affairs Strategist

    6 days ago

    Melbourne, Victoria, Australia Gilead Full time

    At Gilead, we're committed to creating a healthier world for all people. Our mission requires collaboration, determination, and a relentless drive to make a difference.About the RoleThe Associate Director, Regulatory Affairs will play a key role in leading projects for the Regulatory Affairs team in the ANZ affiliate, working cross-functionally to ensure...

  • Regulatory Affairs Specialist

    2 weeks ago

    Melbourne, Australia ProductLife Group Full time

    Specific Activities and Responsibilities: Must have expertise in Health Authority communications for Initial filings, LCM Activities and for variation submissions.Must have experience and thorough knowledge of the process of submissions at HA without missing any detail or deadline.Must be competent with the current changes and regulations from the HA.Will be...

  • Regulatory Affairs Advisor

    3 weeks ago

    Melbourne, Australia EnergyAustralia Full time

    **About Us** Globally, energy markets are in transition to a net zero future and the entities within these markets are transforming their underlying business models to ensure that they stay relevant, sustainable and profitable. As one of Australia’s largest energy providers, we are proud of **our purpose to lead and accelerate the clean energy...

  • Manager, Regulatory Affairs

    1 week ago

    Melbourne, Australia Elias Recruitment Full time

    Continuously improve regulation and governance for ANSTO - Based at either Lucas Heights (Sydney) or Clayton (Melbourne) - ANSTO is committed to investing in its people **About the role** We have a great opportunity where you can play a pivotal role to ensure ANSTO complies with key regulatory requirements. The Manager, Regulatory Affairs & Compliance...