Associate Director, Global Regulatory Affairs

4 months ago

London, United Kingdom Telix Pharmaceuticals (EMEA) Full time

Telix Pharmaceuticals is a dynamic, fast-growing radiopharmaceutical company with offices in Australia (HQ), Belgium, Japan, Switzerland, and the United States. Our mission is to deliver on the promise of precision medicine through targeted radiation. **At our core, we exist to create products that seek to improve the quality of life for people living with cancer and rare diseases. **You will be supporting the international roll-out of our approved prostate cancer imaging agent and helping us to advance our portfolio of late clinical-stage products that address significant unmet need in oncology and rare diseases.

**See Yourself at Telix**

The Associate Director, Global Regulatory Affairs - Biologics will be primarily responsible for ensuring regulatory objectives are met and align with Telix's corporate objectives. This person will be responsible for the execution of global regulatory strategy and dossier compliance within Telix specifically for products in the early-stage pipeline.

**Key Accountabilities**
- Prepares and executes, in collaboration with other regulatory affairs team members, global regulatory strategies and submission requirements pertaining to assigned projects in line with Telix's objectives and initiatives.
- Leads regulatory agency interactions including, but not limited to, coordination of redaction of briefing package, preparation of meeting minutes and responses to agencies questions.
- Coordinates, reviews, analyses, and consolidates all relevant pharmaceutical and related technical information required for regulatory submission of the company's investigational medicinal products with regulatory agencies (ODD, PIP/PSP, Scientific advices, IND/CTA ).
- Provides regulatory assessments for change management and ensures compliance of the regulatory submissions by filing and/or coordinating regulatory amendments in relation to the change, where applicable.
- Monitors global health authority regulations, guidelines, and specifications including FDA, EMA, Health Canada, Therapeutic Goods Authority to maintain regulatory submission compliance.
- Leads regulatory interaction with health authorities for filings (ex: IND and pre-IND).

**Education and Experience**
- Undergraduate degree in a scientific field (chemistry, biology, pharmaceutical sciences) required; Advanced degree preferred
- 7+ years' experience in regulatory for pharmaceuticals products with a focus on Biological products required
- Direct experience in Radiopharmaceuticals and/or clinical preferred
- Experience across product development (until Marketing Authorization) with a focus on Phases 1 and 2.
- Comprehensive knowledge of drug development process, biopharmaceutical technology, drug manufacturing processes, GMP and related issues
- Ability to understand and interpret any regional regulations and guidance documents as well as common and scientific and technical journals, along with other publications
- Experience working globally in the US and EMEA

At Telix, we believe **everyone counts**, **we strive to be extraordinary**, and **we pursue our goals with determination and integrity**. You will be part of an engaged and supportive group of colleagues who all have a shared** purpose: to help people with cancer and rare diseases live longer, better quality lives. **Being a Telix employee means being a part of a unique, global, interdisciplinary team working to deliver what's next in precision medicine. We have hybrid and remote employees located all around the world.** **We offer competitive salaries, annual performance-based bonuses, an equity-based incentive program, generous vacation, paid wellness days and support for learning and development.

Telix Pharmaceuticals is an equal opportunity employer. We evaluate qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, and other legally protected characteristics.

VIEW OUR RECRUITMENT PRIVACY POLICY HERE

  • Regulatory Affairs Director

    1 week ago

    London, Greater London, United Kingdom Lifelancer Full time

    Job Title: Associate Director Global Regulatory AffairsThe Associate Director Global Regulatory Affairs is a critical role responsible for ensuring regulatory objectives are met and aligned with Telix's corporate goals. This position plays a key part in developing and executing global regulatory strategies and dossier compliance for assigned products.Key...

  • Regulatory Affairs Director

    1 week ago

    London, Greater London, United Kingdom Lifelancer Full time

    Job Title: Associate Director Global Regulatory AffairsThe Associate Director Global Regulatory Affairs is a critical role responsible for ensuring regulatory objectives are met and aligned with Telix's corporate goals. This position plays a key part in developing and executing global regulatory strategies and dossier compliance for assigned products.Key...

  • Associate Director, Global Regulatory Affairs

    4 months ago

    London, United Kingdom Telix Pharmaceuticals (Americas) Full time

    Telix Pharmaceuticals is a dynamic, fast-growing radiopharmaceutical company with offices in Australia (HQ), Belgium, Japan, Switzerland, and the United States. Our mission is to deliver on the promise of precision medicine through targeted radiation. **At our core, we exist to create products that seek to improve the quality of life for people living with...

  • Regulatory Affairs Specialist

    2 weeks ago

    London, Greater London, United Kingdom VRS Regulatory Full time

    Job DescriptionA rare opportunity for an aspiring regulatory affairs professional to join the regulatory team at a global chemical products business:Work under the supervision of an experienced regulatory managerProvide regulatory support to a wide range of chemical productsOngoing and comprehensive trainingAn excellent opportunity to start and establish...

  • Regulatory Affairs Specialist

    2 weeks ago

    London, Greater London, United Kingdom VRS Regulatory Full time

    Job DescriptionA rare opportunity for an aspiring regulatory affairs professional to join the regulatory team at a global chemical products business:Work under the supervision of an experienced regulatory managerProvide regulatory support to a wide range of chemical productsOngoing and comprehensive trainingAn excellent opportunity to start and establish...

  • ociate Director Global Regulatory Affairs

    1 week ago

    London, United Kingdom Lifelancer Full time

    The Associate Director Global Regulatory Affairs is primarily responsible for ensuring regulatory objectives are met and align with Telixs corporate objectives. This person is responsible for the of global regulatory strategy and dossier compliance within Telix specifically for assigned products. Key Accountabilities: Prepares and executes in collaboration...

  • ociate Director Global Regulatory Affairs

    1 week ago

    London, United Kingdom Lifelancer Full time

    The Associate Director Global RegulatoryAffairs is primarily responsible for ensuring regulatory objectivesare met and align with Telixs corporate objectives. This person isresponsible for the of global regulatory strategy and dossiercompliance within Telix specifically for assignedproducts. Key Accountabilities:Prepares and executes in collaboration...

  • Associate Director, Regulatory Affairs

    2 weeks ago

    London, United Kingdom Cpl Healthcare Full time

    Job Title: Associate Director, Regulatory Affairs - Medical Devices Job Type: Full Time, Permanent Position Location: Greater London, UK and some EU locations Remuneration: Attractive salary and package An exciting opportunity to join a growing pharmaceutical company that specializes in Cancer and Supportive Care, Gastroenterology, and Hepatology....

  • Associate Director, Regulatory Affairs

    2 weeks ago

    London, United Kingdom Cpl Healthcare Full time

    Job Title: Associate Director, Regulatory Affairs - Medical Devices Job Type: Full Time, Permanent Position Location: Greater London, UK and some EU locations Remuneration: Attractive salary and package An exciting opportunity to join a growing pharmaceutical company that specializes in Cancer and Supportive Care, Gastroenterology, and Hepatology....

  • Senior Regulatory Affairs Director

    2 weeks ago

    London, Greater London, United Kingdom Cpl Healthcare Full time

    Job Title: Associate Director F/HJob Type: Full Time, Permanent PositionCompany: Cpl HealthcareJob Description:Job Summary:We are seeking an experienced Associate Director to join our Regulatory Affairs team in a senior role. As an Associate Director, you will be responsible for the strategic lifecycle management of our Medical Devices post CE approval and...

  • Senior Regulatory Affairs Director

    2 weeks ago

    London, Greater London, United Kingdom Cpl Healthcare Full time

    Job Title: Associate Director F/HJob Type: Full Time, Permanent PositionCompany: Cpl HealthcareJob Description:Job Summary:We are seeking an experienced Associate Director to join our Regulatory Affairs team in a senior role. As an Associate Director, you will be responsible for the strategic lifecycle management of our Medical Devices post CE approval and...

  • Regulatory Affairs Director

    2 weeks ago

    London, Greater London, United Kingdom Cpl Healthcare Full time

    Job Title: Regulatory Affairs Director - Medical DevicesJob Type: Full Time, Permanent PositionLocation: Remote or On-SiteRemuneration: Attractive salary and packageCpl Healthcare is seeking a highly experienced Regulatory Affairs Director to join our team. As a key member of our Medical Devices department, you will be responsible for the strategic lifecycle...

  • Regulatory Affairs Director

    2 weeks ago

    London, Greater London, United Kingdom Cpl Healthcare Full time

    Job Title: Regulatory Affairs Director - Medical DevicesJob Type: Full Time, Permanent PositionLocation: Remote or On-SiteRemuneration: Attractive salary and packageCpl Healthcare is seeking a highly experienced Regulatory Affairs Director to join our team. As a key member of our Medical Devices department, you will be responsible for the strategic lifecycle...

  • Regulatory Affairs Director

    2 weeks ago

    London, Greater London, United Kingdom MSD Full time

    Job Description**About the Role**We are seeking a highly skilled and experienced Regulatory Affairs Director to join our team at MSD. As an Associate Director, Regulatory Affairs, you will play a key role in managing a team of Regulatory Affairs Specialists and ensuring the smooth operation of all registration activities across the team's defined...

  • Regulatory Affairs Director

    2 weeks ago

    London, Greater London, United Kingdom MSD Full time

    Job Description**About the Role**We are seeking a highly skilled and experienced Regulatory Affairs Director to join our team at MSD. As an Associate Director, Regulatory Affairs, you will play a key role in managing a team of Regulatory Affairs Specialists and ensuring the smooth operation of all registration activities across the team's defined...

  • Regulatory Affairs Director

    4 days ago

    London, Greater London, United Kingdom Advanced Resource Managers Full time

    Associate Director Regulatory Affairs - CMCAdvanced Resource Managers is seeking an experienced Associate Director of Regulatory Affairs - CMC to drive and lead regulatory CMC strategy for a leading Biotech business through a CRO. This role will focus on working with one of their main partners in the EMEA region.Key Responsibilities:Develop and execute CMC...

  • Regulatory Affairs Director

    4 days ago

    London, Greater London, United Kingdom Advanced Resource Managers Full time

    Associate Director Regulatory Affairs - CMCAdvanced Resource Managers is seeking an experienced Associate Director of Regulatory Affairs - CMC to drive and lead regulatory CMC strategy for a leading Biotech business through a CRO. This role will focus on working with one of their main partners in the EMEA region.Key Responsibilities:Develop and execute CMC...

  • Regulatory Affairs and Policy Director

    2 weeks ago

    London, Greater London, United Kingdom Dun & Bradstree Full time

    About the RoleThe Director, Public Policy and Regulatory Affairs – Europe is a key position within Dun & Bradstreet's Compliance and Ethics department. This role is responsible for monitoring policy, legislative, regulatory, and judicial trends affecting our business model and strategy across European markets.Key ResponsibilitiesCollaborate with business...

  • Regulatory Affairs and Policy Director

    2 weeks ago

    London, Greater London, United Kingdom Dun & Bradstree Full time

    About the RoleThe Director, Public Policy and Regulatory Affairs – Europe is a key position within Dun & Bradstreet's Compliance and Ethics department. This role is responsible for monitoring policy, legislative, regulatory, and judicial trends affecting our business model and strategy across European markets.Key ResponsibilitiesCollaborate with business...

  • Director of Public Policy and Regulatory Affairs

    1 week ago

    London, Greater London, United Kingdom Dun & Bradstree Full time

    Director, Public Policy and Regulatory AffairsAbout the RoleDun & Bradstreet is seeking a highly skilled Director, Public Policy and Regulatory Affairs to join our team in London. As a key member of our Compliance & Ethics leadership, you will be responsible for monitoring policy, legislative, regulatory, and judicial trends affecting our business model and...