Regulatory Affairs Manager - Melbourne, Australia - D'Arcy Weil

D'Arcy Weil

Verified Company

Melbourne, Australia

3 weeks ago

Posted by:

Olivia Brown

beBee Recruiter

Description

Leading pharmaceutical company dedicated to improving global healthcare.

Strong focus on research, innovation, and ethical practices.
Diverse portfolio of lifechanging 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 nonconformances, ensuring timely reporting to regulatory authorities, in line with GCP requirements.
Coordinate inspections, audits, and regulatory agency interactions, providing necessary documentation, responses, and followup 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, problemsolving, and critical thinking skills.
Exceptional written and verbal communication abilities, including negotiation and persuasion skills.
Ability to thrive in a fastpaced, deadlinedriven environment.
Detailoriented 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.