Manager, Global Regulatory Affairs

Telix Pharmaceuticals; Vancouver; On-site; CAD 100,000 - 130,000; Full time

Job summary

A leading pharmaceutical company is seeking a Manager GRA Global to oversee Regulatory Affairs for the PSMA portfolio. This role requires extensive experience in regulatory strategies, communication with authorities, and collaboration across teams to ensure compliance and successful product registrations.

Qualifications

• 7 years leading Regulatory Affairs in Nuclear Medicine or Pharmaceutical environments.
• Extensive experience collaborating with the FDA and working in a USFDA-regulated environment.
• Demonstrated knowledge of Regulatory and ICH guidelines.

Responsibilities

• Develop and implement regulatory strategies for clinical and commercial products globally.
• Review and approve regulatory submissions to ensure compliance.
• Communication with Regulatory Authorities for submission management.

Skills

Proofreading

FDA Regulations

Biotechnology

Clinical Trials

Research & Development

Writing Skills

Education

7 years experience in Regulatory Affairs

Tools

Adobe Acrobat

Job description

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 global 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 cross-functional 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 cross-functional 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 multi-regional 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 decision-making 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 :

• 7 years experience leading Regulatory Affairs in the Nuclear Medicine or Pharmaceutical environment required
• Extensive experience in collaborating with the FDA.
• Experience working in a USFDA-regulated 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 Asia-Pacific region.
• Proficient understanding of both early and late-stage drug development processes including clinical and non-clinical 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

Key Skills

Proofreading,Adobe Acrobat,FDA Regulations,Manufacturing & Controls,Biotechnology,Clinical Trials,Research & Development,GLP,cGMP,Product Development,Chemistry,Writing Skills

Employment Type : Full Time

Experience : years

Vacancy : 1

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