- Bring innovative regulatory approaches, deeply rooted in science to lead the team in discussion with global health authorities to find the best development strategies for novel therapies in the area.
- Be responsible for the development, implementation and maintenance of robust global regulatory strategies for transformational therapies targeted to address unmet needs in Oncology in different phases of development.
- Drive the execution of the regulatory strategies for select projects through close collaboration with functional areas and ensure the regulatory strategies are aligned with the overall Therapeutic Area strategy, regional strategies, CMC-RA strategy, and commercial strategy.
- Lead the Global Regulatory Team (GRT) and contribute effectively on multiple cross-functional teams including but not limited to the Compound Development Team, Global Dossier Team, Clinical Team, and the Labeling Working Group.
- Ensure that regulatory strategies also take into account non-regulatory market access issues (e.g., health technology assessments, payor demands)
- Ensure, facilitate and/or lead the development or enhancement of constructive relationships and associations with Health Authorities and thought leaders in appropriate business critical settings.
- Provide strategic direction to the teams and critical review of key Health Authority submissions such as IND/CTAs, meeting requests, briefing documents, response documents and marketing and supplemental applications.
- Lead the preparation and participate in meetings with FDA, EMA, PMDA, CDE, Health Canada and other Health Authorities (HAs) as required.
- Serve as a member of LWG to create or update the CCDS and contributes to the development of local labels as appropriate.
- Provides regulatory input to clinical development programs, risk/benefit assessments, medical affairs programs and for the target label.
- Drive innovative regulatory strategies and advance regulatory knowledge sharing, identify process improvement opportunities for cell/gene therapies, and facilitate policy shaping as the GRA Oncology point of contact for cell/gene therapy regulatory policy
- Lead a Cell/Gene Therapy Community of Practice for GRA Oncology to leverage experiences and drive efficiencies for CAR-T/gene therapy products under development in the TA
- Ensure compliance with internal and external policies and legislation.
- Support or lead Due Diligence activities as appropriate.
- Minimum of a B.S. in a life sciences or technical discipline is required
- An advanced degree in the biological sciences is preferred (e.g., M.S., Ph.D., M.D.)
- A minimum of 15 years in drug development any of the following areas (e.g. Global Regulatory Affairs, R&D or health authority role) is required.
- 10 years within the pharmaceutical/biotech industry is required, along with a minimum 5 years of recent regulatory affairs experience
- A track record of innovative scientific thinking and application is required
- Significant experience in the development and execution of global regulatory strategies, the drug development process, regulatory compliance, and regulatory strategy for product lifecycle management is required
- Experience establishing productive working relationships with Health Authorities and gaining a deep understanding of how regulators view certain drug development issues is required
- Experience leading a matrixed global team of diverse individuals is required
- Strong preference for candidates successfully working on advanced therapies (gene and cell therapies)
- Strong preference for candidates successfully working on both early and late development programs.
-
Administratief Medewerker
2 weken geleden
Van Mossel Automotive Groep Rotterdam, NederlandBen je toe aan een uitdagende functie in de leasewereld? Ben je administratief sterk maar heb je ook een commerciële aanleg? Zet jij net dat stapje extra voor de klant? Lees dan snel verder, want dan is dit de baan voor jou_ · **Wat ga je doen?** · Ter versterking van Van Mossel ...
-
Ventilation Practitioner Neonatologie
3 dagen geleden
Erasmus MC Rotterdam, Nederland**Ventilation Practitioner Neonatologie (in opleiding)**: Ben jij een gedreven NICU verpleegkundige met passie voor beademingszorg? Wij zoeken enthousiaste en leergierige NICU verpleegkundigen die zich willen specialiseren tot Ventilation Practitioner. Er zijn 2 opleidingsplaatse ...
-
Onderzoekscoördinator Onderzoeksbureau Sophia
3 dagen geleden
Erasmus MC Rotterdam, Nederland**Onderzoekscoördinator Onderzoeksbureau Sophia**: Word onderzoekscoördinator in ons team en draag bij aan de kwaliteit van wetenschappelijk onderzoek binnen Erasmus MC · - Reageer t/m · TS · uur · - HBO · - Wetenschap en Onderzoek · Solliciteer- Reageer t/m · TS · - Functie in ...
-
Commercieel Winkelmedewerker Schoonenberg
3 dagen geleden
Sonova Audiological Care Nederland B.V. Rotterdam, Nederland**Commercieel winkelmedewerker** **bij Schoonenberg** · **Organisatie** · Sonova Audiological Care Nederland is onderdeel van Sonova, waarvan het hoofdkantoor in Zwitserland gevestigd is. Sonova is een toonaangevende fabrikant van innovatieve hooroplossingen. Wij zijn onder ander ...
-
Phd Candidate On Novel Antimicrobials for Bacterial
2 dagen geleden
Erasmus MC Rotterdam, NederlandReageer t/m · TS · - 36 uur · - WO · - Wetenschap en Onderzoek · Solliciteer- Reageer t/m · TS · - Functie inhoud**Functie inhoud**: · We offer a 4-year PhD position to test a new generation of antibiotics as a treatment for respiratory tract infections. This project is funded ...
-
Opleider Sector Onderwijs
3 dagen geleden
Erasmus MC Rotterdam, Nederland**Opleider Sector Onderwijs**: Draag jij als opleider bij aan loopbaanontwikkeling en deskundigheidsbevordering voor zorgprofessionals. Wij zetten ons in voor kwalitatief hoogstaand onderwijs voor onze studenten, professionals in opleiding en zorgmedewrekers. Sluit jij je bij ons ...
-
Administratief Medewerker
3 dagen geleden
Ease2pay Rotterdam, Nederland**_Ease2pay is een Rotterdamse scale-up en specialist in selfservice oplossingen voor de mobiliteitssector. Het bedrijf ontwikkelt slimme en gebruiksvriendelijke apps waarin gebruikers op locaties, zoals parkeerplaatsen, tankstations, camperterreinen, (jacht)havens en markten zel ...
-
Vacature Hulpkracht/dierverzorger Anicura
2 weken geleden
AniCura Nederland Rijswijk, NederlandVoor ons team opname-spoed & intensieve zorg, locatie Specialistisch Verwijscentrum te Rijswijk (Plaspoelpolder), komen wij graag in contact met een enthousiaste hulpkracht/dierverzorger voor 24 uur per week, voor de maanden mei t/m augustus en/of september. · **Over AniCura Dier ...
-
Huishoudelijke Hulp
2 weken geleden
Thuiszorg VidaCare Voorburg, Nederland**Als huishoudelijk hulp in de thuiszorg in Voorburg zorg jij voor een aangenaam thuis voor jouw cliënten bij jou in de buurt van maandag t/m vrijdag, tussen 9.00 en 17.00 uur en zaterdag tussen 8.00 en 12.00 uur. Je bent ook van harte welkom als je opzoek bent naar een bijbaan.* ...
-
Medewerker Front Office
2 weken geleden
Veiligheidsregio Zuid-Holland Zuid Dordrecht, Nederland**Wat ga je doen als medewerker front office**: · Als medewerker front office ben jij het gezicht van de organisatie. Het is dus van groot belang dat je klanten correct en netjes te woord staat. Je beheert de telefooncentrale en verbindt inkomende telefoontjes door. Bij de recept ...
-
Category Manager, Automotive
1 week geleden
Catawiki Den Haag, NederlandWho we are · ,, - at Catawiki, we come across exceptional objects such as these every day. · Catawiki is the leading online marketplace to buy and sell special objects. We offer over 75,000 special objects in auction every week — each reviewed and selected by one of Catawiki's hu ...
-
Head of Information Security
3 weken geleden
Catawiki Den Haag, NederlandWho we are · ,, - at Catawiki, we come across exceptional objects such as these every day. · Catawiki is the leading online marketplace to buy and sell special objects. We offer over 75,000 special objects in auction every week — each reviewed and selected by one of Catawiki's hu ...
-
Customer Service Representative
1 week geleden
Catawiki Den Haag, NederlandWho we are · ,, - at Catawiki, we come across exceptional objects such as these every day. · Catawiki is the leading online marketplace to buy and sell special objects. We offer over 75,000 special objects in auction every week — each reviewed and selected by one of Catawiki's hu ...
-
Learning & Development Intern
1 week geleden
Catawiki Den Haag, NederlandWho we are · ,, - at Catawiki, we come across exceptional objects such as these every day. · Catawiki is the leading online marketplace to buy and sell special objects. We offer over 75,000 special objects in auction every week — each reviewed and selected by one of Catawiki's hu ...
-
1e Autotechnicus Vianen
1 week geleden
Leseman Car Care B.V. Vianen, NederlandLeseman Car Care is dé expert op het gebied van auto's klaarstomen voor remarketing. Met ongeveer 250 medewerkers bedienen we onze klanten vanuit 4 vestigingen in Nederland (Tilburg, Breda, Vianen en Nijkerk). Vanwege onze sterke groei, zijn wij op zoek naar een technisch special ...
-
1e Autotechnicus Vianen
1 week geleden
Leseman Car Care B.V. Vianen, NederlandLeseman Car Care is dé expert op het gebied van auto's klaarstomen voor remarketing. Met ongeveer 250 medewerkers bedienen we onze klanten vanuit 4 vestigingen in Nederland (Tilburg, Breda, Vianen en Nijkerk). Vanwege onze sterke groei, zijn wij op zoek naar een technisch special ...
-
Intern, Translational Data Science
3 weken geleden
Genmab Utrecht, NederlandAt Genmab, we're committed to building extra[not]ordinary futures together, by developing antibody products and pioneering, knock-your-socks-off therapies that change the lives of patients and the future of cancer treatment and serious diseases. From our people who are caring, ca ...
-
Research Associate, Upstream Processing
1 week geleden
Genmab Utrecht, NederlandAt Genmab, we're committed to building extra[not]ordinary futures together, by developing antibody products and pioneering, knock-your-socks-off therapies that change the lives of patients and the future of cancer treatment and serious diseases. From our people who are caring, ca ...
-
Scientific Communication Associate
1 week geleden
Genmab Utrecht, NederlandAt Genmab, we're committed to building extra[not]ordinary futures together, by developing antibody products and pioneering, knock-your-socks-off therapies that change the lives of patients and the future of cancer treatment and serious diseases. From our people who are caring, ca ...
-
Associate Director, Qp Operations
3 weken geleden
Bristol-Myers Squibb Utrecht, Nederland**Working with Us** · Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production ...
Senior Director, Global Regulatory Leader, CAR-T Therapy - South Holland, Nederland - J&J Family of Companies
Beschrijving
Senior Director, Global Regulatory Leader, CAR-T Therapy W
Description
Johnson & Johnson is currently seeking a Senior Director, Global Regulatory Leader for transformational chimeric antigen receptor T (CAR-T) cell products within the Oncology Therapeutic Area portfolio. This position can be located either in Raritan, NJ; Titusville, NJ; Spring House, PA; Beerse, Belgium; Leiden, Netherlands; or High Wycombe, England.
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at
Johnson & Johnson discovers and develops innovative medical solutions to address important unmet medical needs in oncology, immunology, neuroscience, infectious diseases and vaccines, cardiovascular, metabolic, and retinal diseases.
Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer. And our culture is interconnected by the shared values of Our Credo. It's a culture that celebrates diversity and diverse perspectives. It helps employees achieve an effective mix between work and home life and supports their efforts to have a positive impact on their communities.
The Senior Director, Global Regulatory Leader, CAR-T Therapy will be responsible for the development, implementation and maintenance of global regulatory strategies for transformational therapies in the Oncology portfolio.
Key Responsibilities:
Qualifications
Qualifications
Education:
Experience and Skills:
Required:
Preferred:
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
The anticipated base pay range for this position in the US is $187,000 to $322,000.
For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit
Primary Location NA-US-New Jersey-Raritan
Other Locations Europe/Middle East/Africa-United Kingdom-England-High Wycombe, NA-US-Pennsylvania-Spring House, Europe/Middle East/Africa-Netherlands-South Holland-Leiden, Europe/Middle East/Africa-Belgium-Antwerp-Beerse, NA-US-New Jersey-Titusville
Organization Janssen Research & Development, LLC (6084)
Job Function Regulatory Affairs
Req ID: W
