Associate Director, Global Regulatory Affairs
vor 4 Monaten
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 is primarily responsible for ensuring regulatory objectives are met and align with Telix's corporate objectives. This person is responsible for the execution of global regulatory strategy and dossier compliance within Telix specifically for assigned products.
**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.
- Prepares, 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, BLA/MAA).
- 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 IND and BLA filings (or equivalent).
**Education and Experience**:
- Undergraduate degree in a scientific field (chemistry, biology, pharmaceutical sciences) required; Advanced degree preferred
- 7+ years' experience in regulatory affairs for pharmaceuticals products
- Direct experience in Radiopharmaceuticals, biologicals, and/or clinical preferred
- Experience across product development to Marketing Authorization
- 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 publications
- Experience working globally in the US and EMEA
**Key Capabilities**:
- Inclusive mindset: Demonstrate an understanding and appreciation for diversity, and actively work to create an inclusive environment where everyone feels valued and respected
- Creativity and innovation: Possess a willingness to think outside the box and come up with unique and creative solutions to challenges
- Commitment to excellence: Take pride in your work and consistently strive for excellence in everything you do
- Results-oriented: Driven to achieve goals and objectives, with a strong focus on delivering measurable results
- Ethical behavior: Act with integrity and demonstrate a commitment to ethical behavior in all interactions with colleagues and stakeholders
- Adaptability: Comfortable working in a dynamic environment, able to adjust to changing priorities, and willing to take on new challenges
- Strong communication skills: Able to communicate effectively with colleagues and stakeholders at all levels, using clear and concise language
- Collaboration: Work effectively as part of a team, actively sharing knowledge and expertise to achieve common goals
- Resilience: Demonstrate the ability to bounce back from setbacks and persevere in the face of challenges
- Continuous learning: Show a commitment to ongoing learning and professional development, continually seeking out opportunities to expand your knowledge and skills
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 opport
-
Regulatory Affairs Director
Vor 6 Tagen
Genf, Genf, Schweiz Teoxane SA VollzeitAt Teoxane Laboratories, we specialize in the design and manufacturing of hyaluronic acid-based dermal fillers and dermocosmetics. Our strength lies in offering a global patient care experience.About the RoleWe are seeking a highly experienced Regulatory Affairs Director to lead our EU & US regulatory team dedicated to Innovation & Life-cycle projects. As a...
-
Regulatory Affairs Director
vor 4 Wochen
Genf, Genf, Schweiz Teoxane SA VollzeitAbout Teoxane SATeoxane Laboratories is a pioneering company in the design and manufacturing of hyaluronic acid-based dermal fillers and dermocosmetics. Our commitment to innovation, quality, and patient care has led us to establish a global presence.Job OverviewWe are seeking an experienced Regulatory Affairs professional to join our team as Regulatory...
-
Specialist, Global Regulatory Affairs
Vor 3 Tagen
Genf, Schweiz Telix Pharmaceuticals Limited VollzeitSee Yourself at TelixTelix is currently seeking a Specialist to join our Global Regulatory Affairs team in Europe. This position is responsible for the preparation and execution of the regulatory strategy and dossier compliance for dedicated products in the EMEA region.Key Accountabilities:Prepares and executes, in collaboration with other regulatory affairs...
-
Regulatory Affairs Cmc Manager
vor 5 Monaten
Genf, GE, Schweiz OM Pharma Ltd. VollzeitLocation: Meyrin, Geneva, CH- Division: - Division: Regulatory Affairs- Job Type: Permanent role We are recruiting a **Regulatory Affairs CMC Manager** at our headquarters and biotech production site in Geneva. Reporting to the Head of CMC, your mission is to provide expertise on regulatory CMC activities for initial registration in the context of...
-
[switzerland] Associate Director, Communications
vor 5 Monaten
Genf, GE, Schweiz Santen Vollzeit**Company Description** Santen **is a specialized life sciences company with a proud 130-year heritage focused exclusively on ophthalmology. As a Japan-originated, global company with our footprint in over 60 countries, we are dedicated to delivering innovative treatments and digital solutions for eye health and addressing vision-related social issues for...
-
Head of Regulatory Affairs
vor 3 Monaten
Genf, Schweiz Teoxane SA VollzeitHead of Regulatory Affairs (EU & US regions)Date: 18 sept. 2024Teoxane Laboratories were established in Geneva, Switzerland, in 2003. They are specialized in the design and manufacturing of hyaluronic acid-based dermal fillers and dermocosmetics. Teoxane's strength is to offer global patient care. Using its products, practitioners are able to fill all kinds...
-
Genf, Genf, Schweiz Teoxane SA VollzeitAbout Teoxane SAWe are a specialized company in the design and manufacturing of hyaluronic acid-based dermal fillers and dermocosmetics. Our strength lies in offering global patient care, allowing practitioners to restore youthful volume to the face and treat the neck and décolleté with natural results.In our quest for growth, we seek an exceptional...
-
External Affairs Vice President
vor 1 Monat
Genf, GE, Schweiz JTI - Japan Tobacco International VollzeitAt JTI we celebrate differences, and everyone truly belongs. **46,000 people from all over the world** are continuously building their unique success story with us.** 83% of employees feel happy **working at JTI. To make a difference with us, all you need to do is bring your **human best.** **External Affairs Vice President**: The External Affairs Vice...
-
Regulatory Affairs Intern
vor 3 Monaten
1203 Genf, GE, Schweiz Teoxane Vollzeit**Date**:9 oct. 2024 **Lieu**: Genève, Corporate, 1203 **Entreprise**:teoxanesa Teoxane Laboratories were established in Geneva, Switzerland, in 2003. They are specialized in the design and manufacturing of hyaluronic acid-based dermal fillers and dermocosmetics. Teoxane strength is to offer a global patient care. Using its products, practitioners are...
-
Associate Director for Global Advocacy
vor 5 Monaten
Genf, GE, Schweiz Center for Reproductive Rights Vollzeit**Job Title**: Associate Director for Global Advocacy (Geneva) **Department**: Global Advocacy **Center Background**: The Center for Reproductive Rights (the Center) is a global human rights organization working to ensure that reproductive rights are protected in law as fundamental human rights around the world. With offices in New York City, New York;...
-
Regulatory Affairs CMC Manager
vor 3 Monaten
Genf, Schweiz Ompharma VollzeitWe are recruiting a Regulatory Affairs CMC Manager at our headquarters and biotech production site in Geneva. Reporting to the Head of CMC, your mission is to provide expertise on regulatory CMC activities for initial registration in the context of development projects and lifecycle activities, while ensuring regulatory compliance of the registered products...
-
Genf, Schweiz IPSOS SA VollzeitIpsos is a global leader in survey-based market research activities, present in 90 markets andemploying more than 18,000 people. Our passionately curious research professionals,analysts and scientists have built unique multi-specialist capabilities that provideunderstanding and powerful insight into the actions, opinions and motivations of...
-
Regulatory Affairs Expert for EU and US Regions
vor 4 Wochen
Genf, Genf, Schweiz Teoxane SA VollzeitAbout Teoxane SAWe are a leading company in the design and manufacturing of hyaluronic acid-based dermal fillers and dermocosmetics.Our team is passionate about providing global patient care, and we use our products to help practitioners restore youthful volume to the face, treat the neck and décolleté, and achieve natural results.About the RoleWe are...
-
Associate Director, Geneva
vor 4 Monaten
Genf, GE, Schweiz Human Rights Watch Vollzeit**FULL-TIME JOB VACANCY** **ASSOCIATE DIRECTOR** **Development and Outreach Department** **Geneva Office** **Application Deadline: September 17, 2024** The Development and Outreach Department of Human Rights Watch ("HRW") is seeking applicants for the position of Associate Director to focus on fundraising, including outreach events and initiatives, in the...
-
Genf, GE, Schweiz The Global Fund VollzeitThe advisory practice of the OIG supports the Global Fund’s mission of ending AIDS, tuberculosis and malaria as epidemics by generating “insight for impact”. The team helps the Global Fund address tough issues and new challenges, improve its ways of working to operate more efficiently, and seize opportunities to enhance its impact in fighting pandemics...
-
Global Clinical Lead, Haematology
vor 3 Monaten
Genf, GE, Schweiz Telix Pharmaceuticals (EMEA) VollzeitTelix 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...
-
Global Clinical Lead, Early Development
vor 2 Monaten
Genf, GE, Schweiz Telix Pharmaceuticals (EMEA) VollzeitTelix 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...
-
Global Clinical Lead, Neuro-oncology Diagnostic
vor 3 Monaten
Genf, GE, Schweiz Telix Pharmaceuticals (EMEA) VollzeitTelix 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...
-
Director of Compliance
vor 3 Monaten
Genf, GE, Schweiz PostPro Ltd Vollzeit**Job Summary** We are delighted to be assisting a key strategic partner with the recruitment of a Director of Compliance for a leading RegTech company based in Geneva. This dynamic organisation is at the forefront of regulatory technology, providing cutting-edge solutions to streamline compliance processes. They are seeking a seasoned Director of Compliance...
-
(Junior) Consultant Banking Regulatory
vor 5 Monaten
Genf, GE, Schweiz BearingPoint Global VollzeitDeine Benefits Corporate Benefits Flexibles Arbeiten Mentorship Persönliche Weiterentwicklung Teamspirit Vertrauensurlaub Vergütungsmodell Work-Life-Choice Deine zukünftigen Aufgaben BearingPoint is a leading independent management and technology consulting firm in Europe. As part of the strengthening of its activities in Switzerland, BearingPoint is...
