Current jobs related to Senior Director Regulatory Affairs Strategy - Plainsboro, New Jersey - Genmab
-
Regulatory Affairs Director
3 weeks ago
Plainsboro, New Jersey, United States Firmenich Incorporated Full timeJob SummaryFirmenich Incorporated seeks a highly skilled Regulatory Affairs Director to lead the Regulatory Affairs function with a focus on serving internal and external customers and business units, driving business impact, and contributing to value creation.Key ResponsibilitiesProvide thought leadership, strategy, and governance regarding regulatory...
-
Senior Manager Regulatory Affairs Specialist
4 weeks ago
Plainsboro Center, New Jersey, United States Sun Pharmaceutical Industries, Inc. Full timeJoin Our Team as a Senior Manager, Regulatory AffairsAt Sun Pharmaceutical Industries, Inc., we are committed to making good health accessible and affordable to local communities and society at large. We are seeking a highly skilled and experienced Senior Manager, Regulatory Affairs to join our team.About the RoleThe Senior Manager, Regulatory Affairs will...
-
Senior Manager
4 weeks ago
Plainsboro, New Jersey, United States Novo Nordisk Full timeAbout the RoleAs a Senior Manager at Novo Nordisk, you will lead the execution of observational research studies, leveraging real-world data to drive innovation and improve patient care. This role is part of the Clinical, Medical and Regulatory (CMR) department, which is at the forefront of developing and implementing regulatory strategies with the FDA,...
-
Associate Director
4 weeks ago
Plainsboro, New Jersey, United States Novo Nordisk AS Full timeAbout the RoleThe Communications Department at Novo Nordisk A/S is seeking a highly skilled and experienced Associate Director to join our team. As a key member of our department, you will be responsible for developing and executing holistic, integrated communications plans for major brand, disease state, and pipeline products within Novo Nordisk Inc.Key...
-
Associate Director, Rare Disease Portfolio Lead
3 weeks ago
Plainsboro, New Jersey, United States Novo Nordisk Full timeJob DescriptionJob Title: Associate Director, Rare Disease Portfolio LeadJob Summary:We are seeking an experienced Associate Director to lead our Rare Disease Portfolio in the United States. The successful candidate will be responsible for developing and executing commercial strategies to drive business growth and improve patient outcomes.Key...
-
Associate Director
4 weeks ago
Plainsboro, New Jersey, United States Novo Nordisk Full timeAbout the DepartmentThe Strategy & Rare Disease (STARS) organization drives the long-term strategic direction of Novo Nordisk Inc. (NNI)/North America Operations (NAO) and leads all US commercial efforts for Novo Nordisk's Rare Disease portfolio.The mandate of STARS is to facilitate the development and to coordinate the execution of the long-term strategy,...
-
International Medical Director
3 weeks ago
Plainsboro, New Jersey, United States Novo Nordisk Full timeAbout the RoleWe are seeking an experienced Medical Director to join our Liver Disease team at Novo Nordisk. As a key member of our Global Development Hub, you will play a critical role in the development of innovative treatments for liver disease.As a Medical Director, you will be responsible for providing clinical and scientific expertise to support the...
-
Senior Brand Manager
3 weeks ago
Plainsboro, New Jersey, United States Novo Nordisk Full timeAbout the RoleThe Senior Brand Manager - Commercial Strategy and Marketing will be a critical driver in ensuring the successful execution of brand/therapy area-level marketing strategy at the channel level.This position will support the orchestration of customer experiences tailored to HCP segments, with a focus on channel coordination, content creation, and...
-
Global Regulatory Expert
4 weeks ago
Plainsboro, New Jersey, United States Novo Nordisk Full timeAbout the DepartmentWe are a global pharmaceutical company with a presence in multiple regions, including the East Coast of the United States. Our Lexington, MA and Plainsboro, NJ facilities bring together the best minds in life science innovation to drive cutting-edge research and development.We support programs from early research through late-stage...
-
Global Program Leader
4 weeks ago
Plainsboro, New Jersey, United States Genmab Full timeJob Title: Senior Director, Global Program LeaderGenmab is seeking an experienced Senior Director, Global Program Leader to drive the strategy and execution of 1-2 clinical stage development programs. This leadership position will be based in Princeton, NJ, with partial remote work.Key Responsibilities:Develop and execute compound strategies, working in...
-
Senior Manager
3 weeks ago
Plainsboro, New Jersey, United States Novo Nordisk Full timeJob SummaryThe Senior Manager - Strategic Pricing and Contracting will be responsible for supporting and optimizing approved strategies across Commercial and Medicare channels and customers with the designated SPC Account Lead. This individual will also identify current market trends or signals that may call for reevaluation of our strategic direction.Key...
-
Plainsboro, New Jersey, United States Genmab Full timeJob OverviewGenmab is seeking a highly skilled Senior Director, Global Drug Safety and Pharmacovigilance to join our team. As a key member of our organization, you will be responsible for leading the global safety strategy and overall safety profile for assigned Genmab products throughout their lifecycle.Key ResponsibilitiesDevelop and implement global...
-
Scientific Director
3 weeks ago
Plainsboro, New Jersey, United States Novo Nordisk Full timeAbout the RoleThe Scientific Director will serve as a subject matter expert, ensuring credibility and competency of the medical team and supporting strategic projects aligned to the Therapy Area priorities.This role will work closely with the Therapy Area Leadership Team and Medical Director team to identify and execute key projects in a timely fashion.Key...
-
Senior Director of Hemophilia Therapy Area
2 weeks ago
Plainsboro, New Jersey, United States BioSpace, Inc. Full timeAbout the PositionThe Associate Director, HCP Experience has overall strategic and operational responsibility as well as tactical pull through of all efforts for Health Care Providers within their designated Hemophilia Therapy Area and for relevant in-line and new product commercialization assets (3 years prior to launch).Key ResponsibilitiesLead the...
-
Associate Director, Biostatistics
4 weeks ago
Plainsboro, New Jersey, United States Genmab Full timeAbout the RoleGenmab is seeking a highly skilled Associate Director, Biostatistics to join our team. As a key member of our biostatistics department, you will play a critical role in supporting the clinical development of compounds and contributing to clinical development strategies and plans.Key Responsibilities:Lead and collaborate with cross-functional...
-
Director, Biostatistics
3 weeks ago
Plainsboro, New Jersey, United States Genmab Full timeJob Title: Director, BiostatisticsGenmab is seeking a highly skilled Director, Biostatistics to join our team. As a key member of our clinical development team, you will be responsible for leading the statistical analysis and interpretation of clinical trial data.Key Responsibilities:Lead the development of statistical analysis plans and protocols for...
-
Senior Account Manager
2 months ago
Plainsboro, New Jersey, United States Russell Tobin Full timeJob Description:As a Senior Account Executive at Russell Tobin, you will be responsible for managing internal clients, providing strategic counsel, and assisting in business development. You will develop and maintain solid client relationships, encouraging a collaborative approach with departmental team members.Key Responsibilities:Manage internal clients,...
-
Senior Clinical Research Scientist
4 weeks ago
Plainsboro, New Jersey, United States Genmab Full timeAbout the RoleGenmab is seeking a highly skilled and experienced Senior Clinical Research Scientist to join our Medical department. As a key member of our team, you will contribute to the implementation of our global development strategy, leading or co-leading one or more clinical trials in a therapeutic area for one or more compounds in various stages of...
-
Radiology Services Director
3 weeks ago
Plainsboro, New Jersey, United States Pennsylvania Medicine Full timeJob Title: Radiology Services DirectorPenn Medicine is dedicated to delivering exceptional patient care, conducting innovative research, and educating future leaders in medicine. As a Radiology Services Director, you will play a critical role in overseeing the administrative and operational aspects of our Radiology Services, ensuring seamless care for both...
-
Plainsboro, New Jersey, United States Genmab Full timeAbout the RoleGenmab is seeking a highly skilled Medical Science Liaison/Senior Medical Science Liaison to join our Global Solid Tumor Medical Affairs team. As a key member of our team, you will be responsible for developing and enhancing professional relationships with medical thought leaders to support Genmab approved products and those in various phases...
Senior Director Regulatory Affairs Strategy
2 months ago
Genmab is seeking an experienced and passionate leader to join our Global Regulatory Affairs (GRA) organization as a Senior Director, Regulatory Affairs Strategy. This is a critical role that will play a key part in advancing our portfolio of development and marketed drugs.
Key Responsibilities- Develop and implement US/global regulatory strategies across all stages of development.
- Lead, manage and mentor a team of regulatory professionals to ensure timely and successful submissions of drug applications to global regulatory agencies.
- Evaluate regulatory risk and recommend mitigation strategies to ensure optimal regulatory success.
- Provide expertise and guidance on global regulatory requirements, guidelines, and changes that may impact the company's products.
- Prepare and review regulatory submissions, including INDs, (s)BLAs for accuracy, completeness, and compliance with regulations and guidelines.
- Evaluate various regulatory mechanisms to optimize product development and ensure that they are implemented, if applicable.
- Consult with senior management to develop and communicate regulatory strategies and recommendations for products and programs.
- Interact with US FDA for assigned projects and lead/participate in meetings with FDA and other health authorities as appropriate.
- Provide expertise and guidance on regulatory requirements, guidelines, and changes that may impact the company's products.
- Build strong relationships with key external stakeholders including regulatory agencies, professional societies, and key opinion leaders.
- Participate in review of and comment on regulatory guidance as relevant.
- Drive continuous improvement initiatives to enhance regulatory processes, systems, and capabilities.
- BSc or MSc level degree preferably within the life sciences (PharmD, PhD, or MD preferred).
- Minimum of 10 years of experience within Regulatory Affairs (Oncology experience preferred).
- Direct interaction/negotiation skills with regulatory authorities (e.g. FDA, EMA).
- A broad knowledge of development and life-cycle management is preferred.
- Strong strategic skills including the ability to make complex decisions and willingness to support difficult positions.
- Solid knowledge and understanding of global and US regulations and the US pharmaceutical commercial landscape.
- Solid knowledge and understanding of complex medical and scientific subject matter as well as evolving regulatory policy and guidance.
- Direct hands-on experience with preparation and submissions of IND, (s)NDA/BLA to US FDA.
- Experience with labeling and PMC/PMR negotiations with US FDA.
- Ability to work well within cross-functional teams.
- Strong communication skills – both oral and written.
- Ability to use appropriate interpersonal styles and techniques and can modify behavior to gain acceptance of ideas or plans.
- Ability to influence others and resolve conflicts.
- Cultural awareness and respect for diversity.
- Unquestionable ethics, professional integrity, and personal values consistent with the Genmab values.
Genmab is an international biotechnology company with a core purpose guiding its unstoppable team to strive towards improving the lives of patients through innovative and differentiated antibody therapeutics.
For more than 20 years, its passionate, innovative and collaborative team has invented next-generation antibody technology platforms and leveraged translational research and data sciences, which has resulted in a proprietary pipeline including bispecific T-cell engagers, next-generation immune checkpoint modulators, effector function enhanced antibodies and antibody-drug conjugates.
To help develop and deliver novel antibody therapies to patients, Genmab has formed 20+ strategic partnerships with biotechnology and pharmaceutical companies.
By 2030, Genmab's vision is to transform the lives of people with cancer and other serious diseases with Knock-Your-Socks-Off (KYSOTM) antibody medicines.
Established in 1999, Genmab is headquartered in Copenhagen, Denmark with locations in Utrecht, the Netherlands, Princeton, New Jersey, U.S. and Tokyo, Japan.
Our Commitment to Diversity, Equity, and InclusionWe are committed to fostering workplace diversity at all levels of the company and we believe it is essential for our continued success.
No applicant shall be discriminated against or treated unfairly because of their race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), national origin, age, disability, or genetic information.
