Current jobs related to Lead Regulatory Affairs Expert - New York, New York - Intellectt Inc
-
Regulatory Affairs Expert
2 days ago
New York, New York, United States Daiichi Sankyo, Inc. Full timeGlobal Regulatory Affairs ExpertDaiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology.With more than 100 years of scientific expertise and a presence in more than 20...
-
New York, New York, United States Daiichi Sankyo, Inc. Full timeJob DescriptionJob Title: Global Regulatory Affairs Labeling Strategy ExpertCompany: Daiichi Sankyo, Inc.Job Summary:We are seeking a highly skilled Global Regulatory Affairs Labeling Strategy Expert to join our team. As a key member of our Global Regulatory Team, you will be responsible for providing strategic and operational leadership on product labeling...
-
Regulatory Affairs Director
2 weeks ago
New York, New York, United States Fairway Consulting Group Full timeJob Title: Associate Director/Director, Regulatory AffairsFairway Consulting Group is seeking a highly experienced Associate Director/Director, Regulatory Affairs to join our team. This is a unique opportunity to work with a leading biopharmaceutical company and contribute to the development of innovative global regulatory strategies.Key...
-
Regulatory Affairs Associate Director
2 weeks ago
New York, New York, United States KMR Search Group Full timeRegulatory Affairs Job Description **Overview** KMR Search Group is seeking an experienced Regulatory Affairs Associate Director to join our team. As a key member of our Regulatory Affairs department, you will be responsible for ensuring compliance with global regulations and guidelines governing pharmaceutical drug development. **Responsibilities** *...
-
Regulatory Affairs and Product Innovation Expert
2 months ago
New York, New York, United States Golden Platter Foods, Inc. Full timeCompany Overview:Golden Platter Foods, Inc. is a leader in the frozen food sector, merging traditional values with modern advancements to produce beloved family meals. As a family-owned enterprise, we prioritize quality and adherence to regulations, ensuring that every item we offer meets exceptional standards. Join a vibrant team dedicated to excellence and...
-
Regulatory Affairs Specialist
4 weeks ago
New York, New York, United States Barrington James Full timeSenior Regulatory Associate - Hybrid, NJ (2-3 days a week)Barrington James is partnering with a global commercial pharmaceutical company that is passionate about bringing generic drugs to market across multiple formulations and dosage forms. They are seeking an Associate Manager or Manager to join their team in a hybrid role based in New Jersey (2-3 days a...
-
Regulatory Affairs Specialist
4 weeks ago
New York, New York, United States SPCSHP Full timeJob Title: Senior Specialist, Regulatory AffairsAbout the Role:We are seeking a highly skilled Senior Specialist, Regulatory Affairs to join our team at SPCSHP. As a key member of our Regulatory Affairs team, you will be responsible for managing all legal and regulatory submissions related to healthcare and pharmaceutical advertising campaigns.Key...
-
Regulatory Affairs Specialist
4 weeks ago
New York, New York, United States Oscar Health Full timeJob Title: Regulatory Affairs SpecialistOscar Health is seeking a highly skilled Regulatory Affairs Specialist to join our Regulatory Legal & Government Affairs team.About the RoleThe Regulatory Affairs Specialist will play a critical role in ensuring that Oscar Health complies with all relevant state and federal regulations. This includes tracking and...
-
Director of Regulatory Affairs
4 days ago
New York, New York, United States NYC Health Hospitals Full timeJob Title: Director of Regulatory AffairsJob Summary:The Director of Regulatory Affairs will oversee the daily operations of the Regulatory Affairs Department at NYC Health and Hospitals, ensuring compliance and patient safety goals are met. This role will develop optimal strategies throughout the regulatory process, promote regulatory readiness, and assist...
-
Regulatory Affairs Director
3 weeks ago
New York, New York, United States Tandym Group Full timeDirector of Regulatory AffairsTandym Group is seeking an experienced healthcare professional to join their leadership team as Director of Regulatory Affairs.Key Responsibilities:Performance Metrics and Outcomes: Identify areas needing improvement and design continuous measurement of performance metrics and outcomes.Compliance and Training: Create and deliver...
-
Regulatory Affairs Associate
7 days ago
New York, New York, United States Oscar Health Full timeJob SummaryOscar Health is seeking a highly skilled Regulatory Affairs Associate to join our Corporate Counsel team. As a key member of our team, you will be responsible for managing the Independent Dispute Resolution process in assigned jurisdictions.The ideal candidate will have a strong background in legal or regulatory affairs, with experience working...
-
Regulatory Affairs Specialist
3 weeks ago
New York, New York, United States Intellectt Inc Full timeJob Description:At Intellectt Inc, we are seeking an experienced Regulatory Affairs Specialist to join our team. The ideal candidate will have a strong background in managing regulatory processes for medical devices or pharmaceuticals.Key Responsibilities:Prepare, review, and submit regulatory documents to regulatory authorities to support product...
-
Regulatory Affairs Specialist
4 weeks ago
New York, New York, United States Randstad Life Sciences US Full timeRandstad Life Sciences US is seeking a Senior Regulatory Affairs Consultant with 10-15 years of experience to join their dedicated Regulatory Affairs team. This role is pivotal in ensuring that the company's innovative products navigate the complex regulatory landscape efficiently and remain compliant with global regulatory requirements. The ideal candidate...
-
Regulatory Affairs Director
4 weeks ago
New York, New York, United States Sun Pharmaceutical Industries, Inc. Full timeSenior Director, Global Regulatory Affairs StrategyThe position will provide regulatory affairs strategic leadership for Sun Pharmaceutical Industries, Inc. and novel drug development programs.Key Responsibilities:Develop and execute novel drug regulatory strategyEnsure development programs are compliant with ICH regulatory requirements and all local country...
-
Regulatory Affairs Director
4 weeks ago
New York, New York, United States NYC Health Hospitals Full timeJob Title: Director of Regulatory AffairsNYC Health + Hospitals/Jacobi is a 457-bed teaching hospital affiliated with the Albert Einstein College of Medicine. The facility has earned numerous Center of Excellence designations, accreditation, and recognition for its renowned Level 1 Trauma Center, Burn Center, Surgical Intensive Care Unit, regional Stroke...
-
Regulatory Affairs Director
3 days ago
New York, New York, United States Workforce Solutions Virens Global Full timeAbout the JobSenior Manager Regulatory Affairs at Workforce Solutions Virens GlobalA well-established consumer products corporation is seeking a Regulatory Affairs Manager. Key responsibilities include:Key ResponsibilitiesEnsure completion of necessary documents during the development life cycle and launchEnsure compliance with policies and product...
-
Regulatory Affairs Specialist
3 days ago
New York, New York, United States Synchron LLC Full timeRegulatory Affairs SpecialistSynchron LLC is seeking a highly skilled Regulatory Affairs Specialist to join our team. As a key member of our regulatory team, you will be responsible for planning and executing regulatory submissions and ensuring regulatory compliance.Key Responsibilities:Provide regulatory strategy and guidance on medical devices throughout...
-
Regulatory Affairs Associate
4 weeks ago
New York, New York, United States Oscar Health Full timeJob SummaryOscar Health is seeking a highly skilled Regulatory Affairs Associate to join our Corporate Counsel team. As a key member of our team, you will be responsible for managing the Independent Dispute Resolution process, working closely with Regulatory Counsel, and providing expertise on state and federal policy for provider dispute and IDR matters.Key...
-
Regulatory Affairs Director
4 days ago
New York, New York, United States NYC Health Hospitals Full timeJob DescriptionAt NYC Health Hospitals, we are seeking a highly skilled and experienced Director of Regulatory Affairs to join our team. As a key member of our leadership team, you will be responsible for overseeing the daily operations of the Regulatory Affairs Department and ensuring compliance with regulatory requirements.Key Responsibilities:Provide...
-
Regulatory Affairs Director
2 weeks ago
New York, New York, United States BioSpace, Inc. Full timeJob SummaryAs a seasoned Regulatory Affairs professional, you will play a critical role in ensuring the success of our pharmaceutical applications by effectively liaising with regulatory agencies, coordinating submissions, and providing strategic guidance to cross-functional teams. Your expertise in regulatory affairs, combined with your ability to navigate...
Lead Regulatory Affairs Expert
2 months ago
Position: Senior Regulatory Affairs Specialist
Company: Intellectt Inc
Role Overview:
The Senior Regulatory Affairs Specialist will play a pivotal role in enhancing and streamlining regulatory processes across various business units. This position is crucial for implementing strategic initiatives and operational activities within the regulatory affairs domain.
Key Responsibilities:
- Oversee the compilation and maintenance of submissions for US 510k and EU IVDR Technical Files.
- Ensure adherence to Corporate and Divisional Policies as well as quality system requirements.
- Prepare and review regulatory submissions for both US and EU markets.
- Proactively identify regulatory challenges and collaborate with cross-functional teams to devise effective solutions.
- Provide regulatory insights for product lifecycle management across designated regions.
- Track the status of applications under regulatory review and relay updates to internal stakeholders.
- Submit necessary reports and ensure timely responses to regulatory authorities.
- Utilize technical expertise to propose strategies for complex regulatory issues.
- Evaluate the acceptability of quality, preclinical, and clinical documentation for submission.
- Assess the impact of design changes on registration in relevant regions.
- Offer strategic regulatory guidance to development teams.
- Ensure that all external communications related to regulatory matters comply with established regulations.
Leadership Responsibilities:
This role requires the ability to lead projects without direct authority, providing guidance to both exempt and non-exempt personnel who work independently on their assignments.
Accountability and Scope:
The individual will independently manage technical and scientific regulatory activities, ensuring compliance with deadlines and effectively communicating with various regulatory agencies. The role demands a thorough understanding of regulatory requirements and the ability to interpret and apply them accurately.
Qualifications:
Minimum of a Bachelor's Degree in a relevant scientific field such as Biology, Chemistry, or Engineering. A Master's degree is advantageous. Certification in regulatory affairs is a plus.
Experience:
A minimum of 5 years of experience in a regulated industry, such as medical devices or pharmaceuticals, is required. Candidates with hands-on experience in US 510k submissions or EU MDR/IVDR technical files will be preferred.
Practical experience in leading cross-functional teams on regulatory and compliance projects is also desirable.
