- Aequor (San Diego, CA)
- US Regulatory Affairs Lead SCOPE OF RESPONSIBILITIES: He/She will be responsible for representing regulatory function to approve promotional material ... preferred Regulatory Certification (RAC) preferred Minimum 5 years in Regulatory Affairs , including leadership roles Experience: Experience in promotional… more
- Integrated Resources, Inc (Atlanta, GA)
- Job Title: Regulatory Affairs Specialist Project Lead I Location: Washington DC, DC (Fully Remote) Duration: 06 months + Part-Time Role- (Mon - Fri 9 AM - 1 ... conflict of interest Candidates must be located in the US Possibility of extension Must-Have Skills: * 3-6 years...and communications with trade associations and health authorities on regulatory policy matters. * Lead proactive advocacy… more
- American Honda Motor Co Inc (Torrance, CA)
- …we want you to join our team to Bring the Future!Job PurposeThe Department Lead , Environmental Regulatory Affairs manages PRO's environmental regulatory ... the skills, courage, persistence, and dreams that will help us reach our future-focused goals. At our core is...both existing and new/nascent business areas. Working with the Regulatory Affairs Division Lead , this… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …area direction and corporate objectives. Serve as Global Regulatory Lead or US regulatory lead on projects as neededTeam Interactions: Provides US ... global representation on project teams; may lead regulatory teams for more complex projects. Leads or supports...industry7 or More Years with direct regulatory affairs experienceManagerial experience preferredExperience with ex- US … more
- Catalent (Manassas, VA)
- …and revised SOPs and guidance pertaining to Regulatory Affairs and regulatory compliance. Will prepare for and lead regulatory meetings, designing ... Associate Director, Regulatory Affairs Position Summary: Catalent is...participation in Catalent-sponsored leadership programs such as NGGL, GOLD, LEAD Now, GM Excellence, and GROW) may be considered… more
- Aequor (Newbury Park, CA)
- …Support the implementation of Veeva Vault, IDMP, EU CTR, and other regulatory initiatives. Work with stakeholders to gather requirements and develop solutions. ... Provide Subject Matter Expertise in Veeva Vault Configuration and Regulatory Processes to a global user base. Develop and deliver training materials and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …The Manager RPM is responsible for supporting the global regulatory lead (GRL), US regulatory lead (USRL) and global regulatory team (GRT) for ... research areas centered around rare diseases and immune disorders. Summary The Manager, Regulatory Affairs - Regulatory Project Management (RPM) provides… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education...development, CMR is involved. The one thing that keeps us all marching to the same beat is our… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …preferred. Experience Qualifications:4 or More Years of proven experience in a regional regulatory lead role7 or More Years of relevant pharmaceutical experience ... and immune disorders.Summary Responsible for leading and developing global regulatory strategy for assigned development projects. Represents Daiichi Sankyo's … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …More Years pharmaceutical industry experience required4 or More Years of direct regulatory affairs experience, including US labeling experience ... US or EU. Preparation of updated Core Data Sheets, and EU and US Documentation: Independently manages, prepares and implements regulatory documents (eg, USPI,… more
- Merck & Co. (Rahway, NJ)
- …a critical role in leading major global initiatives aimed at enhancing Medical Affairs practices. The SRO is a recognized internal management consulting team within ... Medical Operations, driving strategic, large-scale, cross-functional initiatives.Responsibilities:Support the SRO Lead in the execution of extensive, global initiatives, ensuring… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and attend device company HA meetings as appropriateIn collaboration with therapeutic Regulatory leads and CDx lead develop key questions and company ... rare diseases and immune disorders. SummaryLeadership responsibility for global regulatory strategy to support the development of biomarkers, companion diagnostic… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education...development, CMR is involved. The one thing that keeps us all marching to the same beat is our… more
- Merck & Co. (Rockville, MD)
- …knowledge of how regulatory policy is shaped and developed in the United States .Representing the company in assigned areas on industry committees, with ... company's Research Laboratories divisions and most directly with Global Regulatory Affairs and Clinical Safety (GRACS) to...policy matters under the supervision of the Executive Director, US Lead , US Regulatory… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … Regulatory Data Manager will be a key member of the Global Regulatory Affairs (GRA) Process Excellence function, responsible for driving data governance, ... role will need to partner closely with teams and senior leaders from across Regulatory Affairs , as well as cross-functional stakeholders (eg, RA CMC, R&D… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Reg Policy Lead , responsible for tactically coordinating engagement with US regulatory bodies and trade associations, incl. PhRMA. Qualifications: Successful ... working. This role will also work with the Global Regulatory Affairs Leadership Team (GRA-LT) to define...regulatory changesIn the short term, act as the US Reg Intel lead , responsible for collecting,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- … affairs , market access and policy/advocacy (MAPA), Centers of Excellence (COEs), regulatory affairs , and other relevant NNI departments to ensure alignment ... team culture that is made up of diverse skillsets, united by the shared belief that reinvention and learning...pull you in? Are you ready to experiment with us ? The Position The Integrated TA Lead … more
- Lundbeck (MA)
- … us on our journey of growth!This position will cover the Eastern half of the United States .Candidates may live in any state within the Eastern United ... States in close proximity to a major airportPOSITION SUMMARY:The Field Medical Lead - Neurology (East) will lead , coach, train, and provide direction to a… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Serve on Local Labeling Committee (LLC) and provide medical input to Regulatory Affairs Physical Requirements 30% overnight travel required. Position can ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...development, CMR is involved. The one thing that keeps us all marching to the same beat is our… more
- Eisai, Inc (Nutley, NJ)
- …employers to electronically verify the employment eligibility of all new hires in the United States . Please click on the following link for more information: ... hear from you.The Sr Medical Director provides medical leadership for medical affairs strategy, planning and supportive tactics mainly for GU therapeutic area. This… more
