Manager Global Regulatory Affairs PSMA
Manager Global Regulatory Affairs PSMA
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Salary Not Disclosed
1 Vacancy
Job Description
See Yourself at Telix
To support the Groups strategic objectives the Manager GRA Global will oversee Regulatory Affairs for commercial registration activities of PSMA portfolio globally. This role involves conducting regulatory tasks related to new product development securing registrations and managing the product lifecycle globally.
This role will provide comprehensive support for clinical and commercial registrations across the globe while also assisting the Associate Director GRA Global.
Key Accountabilities
- Regulatory Strategy and Planning Develop and implement regulatory strategies for clinical commercial and lifecycle management of products globally. Plan submissions for INDs NDAs MAAs or other relevant regulatory filings in collaboration with crossfunctional teams.
- Support the compilation of IND/NDA dossiers for Telix assets globally by collaborating closely with individual product regulatory leaders.
- Assist in developing registration strategies and managing the registration process through collaboration with crossfunctional teams.
- Submission Management Review and approve regulatory submissions to ensure quality accuracy and compliance with local and global requirements. Monitor submission timelines and ensure timely responses to regulatory authority queries.
- Stay up to date on changes in regulatory guidelines and advise internal teams on their impact.
- Provide assistance to the product regulatory leaders by reviewing change controls as well as quality and manufacturing data for global projects and multiregional clinical trials.
- Communication with Regulatory Authorities Efficient communication with the applicants strategies preparation and presentation for institutions (with the USFDA).
- Interfacing internally with QA Clinical Development Research and Innovation and other functions involved to ensure that dossiers are presented within the scheduled deadlines and that the material provided meets regulatory requirements.
- Participate in decisionmaking processes to align regulatory priorities with business objectives.
- Provide expert advice to senior management on regulatory risks and opportunities.
- Collaborate closely with regional teams including Commercial Supply Chain Quality and Strategic teams to manage ongoing business commitments while ensuring compliance with the latest regulatory requirements.
Education and Experience
- Bachelors degree (science) required
- 7 years experience leading Regulatory Affairs in the Nuclear Medicine or Pharmaceutical environment required
- Extensive experience in collaborating with the FDA required
- Experience working in a USFDAregulated environment
- Demonstrated knowledge of Regulatory and ICH guidelines.
Key Capabilities:
- Strong communication skills effective across all levels of the organization.
- Extensive experience in Regulatory Affairs particularly with the TGA in Australia and ideally experience working with regulatory authorities across the AsiaPacific region.
- Proficient understanding of both early and latestage drug development processes including clinical and nonclinical requirements at an advanced level.
- Strong ability to collaborate effectively with teams across the region.
- Demonstrate a dedication to continuous learning and professional growth actively pursuing opportunities to enhance your expertise and skill set.
- Uphold integrity and exhibit a steadfast commitment to ethical conduct in all dealings with colleagues and stakeholders.
Required Experience:
Exec
Employment Type
Full Time
