Regulatory Affairs Manager

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.