Director of Global Regulatory Affairs
2 weeks ago
Lead Regulatory Strategy for RNA Vaccines
GSK is seeking a highly skilled Director, Global Regulatory Affairs to lead the regulatory strategy for our RNA vaccines portfolio. As a key member of our regulatory team, you will be responsible for developing and implementing regulatory plans to ensure compliance with global regulatory requirements.
Key Responsibilities:
- Develop and implement regulatory strategies to ensure compliance with global regulatory requirements
- Lead cross-functional teams to develop and submit regulatory documents to FDA and other regulatory agencies
- Provide regulatory expertise to support the development and commercialization of RNA vaccines
- Collaborate with internal stakeholders to ensure alignment with business objectives
- Stay up-to-date with changes in regulatory guidelines and rules, and communicate their impact on regulatory strategy
Requirements:
- Bachelor's degree and 10+ years of experience in regulatory affairs, or advanced degree and 5+ years of experience
- Experience in scientific and regulatory affairs in all stages of product development
- Experience in clinical regulatory affairs and CMC regulatory affairs for pre-licensed and licensed biologic products or vaccines
- Knowledge of IND and NDA/BLA regulations and US regulations pertinent to product development and licensure
- Knowledge of scientific basis for clinical development, endpoints, and product CMC
- Experience as liaison with US FDA
Preferred Qualifications:
- Experience at a large pharmaceutical/vaccines company
- Excellent communication skills
- Experience working successfully in a matrix environment
- Strong leadership skills
About GSK:
GSK is a global biopharma company with a special purpose - to unite science, technology, and talent to get ahead of disease together. We prevent and treat disease with vaccines, specialty, and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/immunology, and oncology).
Why GSK?
GSK is a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged, and challenged to be the best they can be. A place where they can be themselves - feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing.
-
Global Regulatory Affairs Director
3 weeks ago
Rockville, Maryland, United States GlaxoSmithKline Full timeJob Overview: We are seeking an Associate Director, Global Regulatory Affairs to join our team at GlaxoSmithKline. **Job Summary:** As an Associate Director, Global Regulatory Affairs, you will be responsible for developing regulatory strategies for assigned assets and ensuring compliance with internal processes and regulatory requirements. **Key...
-
Global Regulatory Affairs Director
2 weeks ago
Rockville, Maryland, United States GSK Full timeJob Title: Global Regulatory Affairs DirectorAt GSK, we are committed to discovering and delivering transformational vaccines and medicines to prevent and change the course of disease. We are seeking a highly skilled Global Regulatory Affairs Director to join our team and play a key role in ensuring the development and execution of our regulatory...
-
Regulatory Affairs Director
2 weeks ago
Rockville, Maryland, United States MaxCyte Inc Full timeJob Title: Director, Regulatory AffairsMaxCyte Inc is seeking a highly experienced Director, Regulatory Affairs to lead the Regulatory function and develop strategies that enable the company to meet business needs as well as safety, quality, and regulatory requirements.Key Responsibilities:Develop and implement regulatory compliance strategies to ensure...
-
Regulatory Affairs Director
2 weeks ago
Rockville, Maryland, United States MaxCyte Inc Full timeJob Title: Director, Regulatory AffairsMaxCyte Inc is seeking a highly experienced Director, Regulatory Affairs to lead the Regulatory function and develop strategies that enable the company to meet business needs as well as safety, quality, and regulatory requirements.Key Responsibilities:Develop and implement regulatory compliance strategies to ensure...
-
Regulatory Affairs Director
2 weeks ago
Rockville, Maryland, United States MaxCyte Inc Full timeJob Title: Director, Regulatory AffairsMaxCyte Inc is seeking a highly experienced Director, Regulatory Affairs to lead the Regulatory function and develop strategies that enable the company to meet business needs, safety, quality, and regulatory requirements.Key Responsibilities:Develop and implement regulatory compliance strategies and plans to ensure...
-
Regulatory Affairs Director
2 weeks ago
Rockville, Maryland, United States GlaxoSmithKline Full timeJob Title: Regulatory Affairs DirectorAt GlaxoSmithKline, we are committed to discovering and delivering transformational vaccines and medicines to prevent and change the course of disease. We are seeking a highly skilled Regulatory Affairs Director to join our team and play a key role in ensuring the development and execution of our regulatory strategy.Key...
-
Regulatory Affairs Director
2 weeks ago
Rockville, Maryland, United States MaxCyte Inc Full timeJob Title: Director, Regulatory AffairsMaxCyte Inc is seeking a highly experienced and skilled Director, Regulatory Affairs to lead the Regulatory function and develop and implement regulatory compliance and strategies that enable the company to meet business needs as well as safety, quality, and regulatory requirements.Key Responsibilities:Develop and...
-
Regulatory Affairs Director
1 week ago
Rockville, Maryland, United States MaxCyte Full timeJob Title: Director, Regulatory AffairsMaxCyte is seeking a highly experienced Director, Regulatory Affairs to lead the Regulatory function and develop strategies that enable the company to meet business needs while ensuring safety, quality, and regulatory compliance.Key Responsibilities:Develop and implement regulatory compliance strategies to maintain...
-
Regulatory Affairs Director
2 weeks ago
Rockville, Maryland, United States MaxCyte Inc Full timeJob Title: Director, Regulatory AffairsMaxCyte Inc is seeking a highly experienced Director, Regulatory Affairs to lead the Regulatory function and develop strategies that enable the company to meet business needs, safety, quality, and regulatory requirements.Key Responsibilities:Develop and implement regulatory compliance and strategies to ensure...
-
Regulatory Affairs Director
6 days ago
Rockville, Maryland, United States MaxCyte Inc Full timeJob Title: Director, Regulatory AffairsMaxCyte Inc is seeking a highly experienced Director, Regulatory Affairs to lead the Regulatory function and develop strategies that enable the company to meet business needs as well as safety, quality, and regulatory requirements.Key Responsibilities:Develop and implement regulatory compliance strategies to ensure...
-
Associate Director Regulatory Affairs CMC
2 weeks ago
Rockville, Maryland, United States Arcellx, Inc. Full timeAbout Arcellx, Inc.Arcellx, Inc. is a clinical-stage biotechnology company reimagining cell therapy by developing innovative immunotherapies for patients with cancer and other incurable diseases. Our mission is to destroy cancer and advance humanity by creating cell therapies that are safer, more effective, and more accessible.Job SummaryWe are seeking an...
-
Associate Director Regulatory Affairs CMC
6 days ago
Rockville, Maryland, United States Arcellx, Inc. Full timeAbout Arcellx, Inc.Arcellx, Inc. is a clinical-stage biotechnology company reimagining cell therapy by developing innovative immunotherapies for patients with cancer and other incurable diseases. Our mission is to destroy cancer and advance humanity by creating cell therapies that are safer, more effective, and more accessible.Our TeamOur team members are...
-
Associate Director, Oncology Regulatory Strategy
2 weeks ago
Rockville, Maryland, United States GSK Full timeJob SummaryWe are seeking an experienced Associate Director to lead our Oncology Regulatory Strategy team. The successful candidate will be responsible for developing and implementing regional regulatory strategies to support the development and launch of new oncology products.Key ResponsibilitiesDevelop and implement regional regulatory strategies to...
-
Rockville, Maryland, United States Links Global Full timeJob OpportunityWe are seeking highly motivated and detail-oriented individuals to join our team as Digital Marketing Interns in International Affairs. As an intern, you will have the opportunity to gain hands-on experience in digital marketing, develop your skills in a dynamic and fast-paced environment, and contribute to the success of our organization.Key...
-
Global Logistics Director
3 weeks ago
Rockville, Maryland, United States MESO SCALE DIAGNOSTICS, LLC. Full timeJob Title: Director of Global LogisticsThe Director of Global Logistics is a key leadership position responsible for the strategic planning and execution of global logistics operations. This role will oversee the development and implementation of supply chain strategies to ensure efficient and effective transportation of goods worldwide.Key...
-
Global Logistics Director
2 weeks ago
Rockville, Maryland, United States MESO SCALE DIAGNOSTICS, LLC. Full timeJob Title: Director, Global LogisticsThe Director of Global Logistics is responsible for leading the development and implementation of the company's global logistics strategy, ensuring the efficient and effective movement of goods and materials worldwide. This role will oversee the planning, execution, and optimization of global supply chain operations, with...
-
Deputy Director, Office of Administration
3 weeks ago
Rockville, Maryland, United States Nuclear Regulatory Commission Full timeJob SummaryThe Nuclear Regulatory Commission is seeking a highly qualified Deputy Director to join our Office of Administration team. As a key member of our leadership team, you will play a critical role in providing strategic leadership and direction to our administrative services program.Key ResponsibilitiesProvide strategic leadership and direction to the...
-
Rockville, Maryland, United States Otsuka Pharmaceutical Co., Ltd. Full timeJob SummaryThe Associate Director, Drug Substance, Pharmaceutical Development will lead process development and optimization of drug substances and will manage manufacturing activities for API, intermediate, and RSMs for assigned projects. The Associate Director, Drug Substance, Pharmaceutical Development will assist with the preparation and review of drug...
-
Branch Director
3 weeks ago
Rockville, Maryland, United States Nuclear Regulatory Commission Full timeJob SummaryThis position is located in the Office of Nuclear Security and Incident Response (NSIR), Division of Security Operations (DSO), Intelligence Liaison and Threat Assessment Branch (ILTAB). The supervisor is Brian Yip. This position is Non Bargaining Unit. This position is subject to Confidential Financial Disclosure reporting requirements. This...
-
Senior Director, Global Operations Strategy
3 weeks ago
Rockville, Maryland, United States EMMES Corporation Full timeJob Title: Senior Director, Global Operations StrategyAt EMMES Corporation, we are seeking a highly skilled and experienced Senior Director, Global Operations Strategy to join our team. This role will be responsible for leading the development and implementation of global commercial processes and strategies for our ophthalmology business.Key...