Regulatory Affairs Manager Jobs
By Jobot At New York, NY, United States
Strong knowledge of OTC drug and device regulations, including labeling requirements
Significant experience with U.S. drug and/or medical device regulatory submissions and maintenance; OTC preferred
Working knowledge of U.S. clinical research and claims support
Excellent written and verbal communication skills
6+ years of experience in U.S. and/or Canada pharmaceutical or medical device Regulatory Affairs
Drug or medical device submission and/or maintenance experience
Senior Manager Regulatory Affairs | $90,000- 140,000/Yr
By PWR Staffing & Recruiting At New York, NY, United States
Ensure claims are compliant with The Avon and local regulatory requirements and consistent across labels, advertising, and other consumer communications
Over 8 years of Regulatory Affairs experience within a regulated industry, preferably skin and personal care products, including OTC
Product development experience is strongly preferred
Skin and personal care, including OTC claim review experience, strongly preferred
Track record adhering to compliance requirements (i.e. FDA, Health Canada, EPA, FTC, cGMP, ISO, etc.)
Strong written communication skills, especially detail oriented and technical material
Reinsurance Prudential And Regulatory Affairs Specialist
By Insight Global At New York, NY, United States
-knowledge and experience in the insurance sector
-prior experience as an insurance supervisor
-prior experience as an actuary, insurance contract lawyer, or consultant in the financial services
-prior experience in coordinating projects involving a wide array of stakeholders.
-prior experience on ESG or cyber matters.
-ability to navigate and understand prudential regulation and supervisory guidance applicable to the insurance sector
Senior Regulatory Affairs Manager - Hybrid
By Hi-Quality Recruits At New York, NY, United States
Ensure claims are compliant with the company and local regulatory requirements and consistent across labels, advertising, and other consumer communications
Over 8 years of Regulatory Affairs experience within a regulated industry, preferably skin and personal care products including OTC
Track record adhering to compliance requirements (i.e. FDA, Health Canada, EPA, FTC, cGMP, ISO, etc.)
Strong written communication skills, especially detail oriented and technical material
Experience communicating with cross-functional teams and customers, including verbal presentations
Excellent organizational and analytical skills to complete assignments accurately
Director Of Quality And Regulatory Affairs; Full Time; Days
By Mount Sinai At , New York, 10029 $140,000 - $230,584 a year
Responsible for supporting the management of an operating budget for the department.
Maintains current knowledge of quality improvement information, patient safety, and regulatory requirements.
Coordinates all documentation requirements for the Performance Improvement and National Patient Safety Goal chapters of The Joint Commission manual.
Supports the coordination and direction all activities to ensure the effective implementation of the Quality Improvement Plan.
Designs, develops, implements and evaluates quality improvement policies and procedures.
Develops and facilitates the use of data collection tools to support data analysis.
Regulatory Affairs Specialist Jobs
By CitiStaffing At New York, NY, United States
Significant experience analyzing securities trading
Excellent computer/technology skills, particularly using systems to retrieve order and trade data and Microsoft Excel
Experience using Relativity and/or Global Relay Retrieval Platforms
Interface with regulators, including negotiating request limitations and response deadlines
Review and prepare documents for production to regulators and ensure timely and accurate responses to all regulatory inquiries
Analysis of requests, responses, and related documents for potential regulatory issues
Regulatory Affairs Associate Jobs
By L’OCCITANE Group At New York, NY, United States
Gain working knowledge of North American cosmetic regulations and product claims substantiation as part of the North America regulatory team
Strong organizational skills with the ability to meet project deadlines
Prepare and submit product notification/registration and updates ensuring accuracy, completeness, and timeliness
Track and maintain accurate records of submissions
Help update and maintain product master database
Provide support with products survey reporting as needed
Director Of Regulatory Affairs
By RH Smart Solutions At New York, NY, United States
Therapeutic area experience in oncology, gastroenterology, rheumatology, and infectious disease is preferred.
10+ years of pharmaceutical industry experience with 7+ years in regulatory affairs
Experience working with the FDA and/or EMA is required. Additional experience with ex-US/ex-EU is preferred.
Excellent verbal and written skills, allowing for an open and effective dialogue throughout the company.
. A successful candidate must have significant experience in early phase of drug
Global experience (EU, ROW, and/or US) is required
Humanitarian Affairs Officer Jobs
By United Nations At , New York, Ny

Evaluation of qualified candidates may include an assessment exercise which may be followed by competency-based interview.

Senior Associate, Content - Legal, Economic, And Regulatory Affairs
By GLG At New York, NY, United States
At least 2 years of experience in government, law, international affairs, journalism, investment management, or a related field
Client service and relationship management skills
Access to free Learning & Development resources including LinkedIn Learning and Harvard ManageMentor
Manage and contribute to editorial development and content strategy
Strong communication and interpersonal skills
Benefits for this role include:
Regulatory Affairs Specialist Jobs
By TMRW Life Sciences, Inc. At , New York, 10013, Ny $100,000 - $150,000 a year
Manages and maintains Regulatory registrations including FURLS, EUDAMED, UDI database and other country specific registration databases,
Reviews promotional material and labeling for compliance with regulatory requirements.
Helps train stakeholders on current and new regulatory requirements to ensure organization-wide compliance.
Bachelor’s degree or equivalent work experience
3+ years related work experience in regulatory affairs required
FDA Class I and II medical device experience required
Regulatory Affairs Manager Jobs
By USK Technologies At New York City Metropolitan Area, United States
You will report to the Senior Manager, Quality, Safety and Regulatory Affairs.
Product development experience strongly preferred
Skin and personal care including OTC claim review experience strongly preferred
Track record adhering to compliance requirements (i.e. FDA, Health Canada, EPA, FTC, cGMP, ISO, etc.)
Strong written communication skills, especially detail oriented and technical material
Experience communicating with cross-functional teams and customers including verbal presentations
Regulatory Affairs/Compliance Assistant
By CitiStaffing At New York City Metropolitan Area, United States

Provide administrative support to the COO/Head of Trading Surveillance, Regulatory Affairs & Compliance.

Product Compliance & Regulatory Affairs Manager
By quip. At New York City Metropolitan Area, United States
7+ years regulatory management experience of Medical Devices, Consumer Electronics and OTC drugs
Experienced leading certification, internal, and supplier qualification audits
Lead evolution of Quality Management System and associated processes to support product, market, company, and business growth
Review product labeling, packaging, advertising, marketing, digital materials for compliance to regulatory requirements
Responsible for all regulatory aspects of NPD from concept to certification through maintenance / renewals
Lead supplier, internal, and certification/maintenance audits, as needed
Director, Administrative And Regulatory Affairs
By GalenusRx At Florida, United States
An equivalent combination of education, training and experience that presents the required knowledge, skills, and abilities will be considered.
Experience with administrative laws, regulations, standards, and guidance for people management.
At least five years in leadership and management required.
Maintains knowledge of all applicable international regulation and regulatory guidance, as well as in-depth product knowledge and clinical / medical knowledge.
Obtain necessary approvals from regulatory agencies and bodies, and tracks and manages all proposal/reporting deadlines, submissions, and status updates.
Excellent written and verbal communication skills.
Senior Specialist, Regulatory Affairs
By H&H Group At Orlando, FL, United States
Good communication skills, strong project management ability and teamwork ability.
Familiar with the process of pet food export to China, experience in official certification documents works.
Salary and benefits will be competitive and commensurate with experience.
At least 1 year working experience in pet food
MOA registration program U.S. official documentation section
Label and advertising compliance review
Director Of Regulatory Affairs
By Trebla Talent At Greater Chicago Area, United States
Strong knowledge of current drug development regulations and guidelines including ICH, FDA and EMA guidelines; NDA experience is required.
Minimum of 10 years of experience across Regulatory Affairs or another transferrable function in biotech/pharma
Both clinical and CMC experience is desired
Bachelor’s degree is required; advanced degree is preferred.
A passion for the psychedelic and mental health industry
Director/Senior Director of Regulatory Affairs
Director Regulatory Affairs Jobs
By Altasciences At United States
Critical thinking skills and ability to acquire and apply knowledge quickly;
Lead, manage and prepare clinical trial submissions;
Lead, manage, prepare, and submit meeting requests and meeting information packages to health agencies;
Lead, manage, prepare, and submit controlled correspondence to regulatory agencies;
8+ years of regulatory experience in an industry setting;
Strong knowledge of drug development and regulatory policy;
Regulatory Affairs Manager Jobs
By Korn Ferry At Boston, MA, United States
5+ years of experience in regulatory affairs environment in nutrition industry.
Excellent knowledge of US and Canada Food Law - Regulations.
Korn Ferry has partnered with our client on their search for the role, Regulatory Affairs Manager.
Ensure compliance of product, ingredients, and claims.
Supply regulatory support for safety files and clinical trials/protocols in order to support R&D.
Vetting and approval of all public materials, including labelling.
Remote: Vice President Regulatory Affairs
By Shepherd Regulatory Search At United States
At least 15 years of Global Regulatory Affairs leadership experience.
Extensive knowledge of ICH, FDA, EMA, HSA, PMDA, MFDS, and international regulations/guidelines.
Provide global regulatory leadership supporting global development.
Proactively participate in the design of US and ex-US regulatory strategies for the development of precision oncology therapies.
Direct and negotiate submissions (IND, CTA, NDA, MAA etc..) and approvals with regulatory authorities.
Form partnerships across the Science Units to provide/facilitate provisions of the appropriate regulatory affairs advice to each area.
California Regulatory Affairs Analyst (Hybrid)
By California ISO At Folsom, CA, United States
Level of Education and Discipline:
Participate in paid on-call rotation and other job-related duties as assigned.
May perform related duties and activities as assigned.
Adheres to and supports the Core Values of the ISO.
Regulatory Affairs Associate Jobs
By Agilent Technologies At California, United States
Compile materials required in submissions, license renewal and annual registrations and maintains updated information about national/regional/global regulatory requirements.
Maintain and updates information about global regulatory requirements.
4+ years of Regulatory Affairs experience
Post-graduate and/or certification/ license may be required.
Review product labeling and marketing materials for accuracy and compliance with regulations.
Respond to customers and/or authorities requests/inquiries dealing with regulations and product compliance.
Regulatory Affairs Consultant (Freelance)
By Alien Technology Transfer At United States
Provide training to company managers and other relevant team members in areas related to regulatory compliance and associated best practices;
Conduct thorough research and stay up-to-date with US regulatory requirements, guidelines, and industry best practices pertaining to healthcare products and pharmaceuticals.
Minimum of 5 years of experience as a Regulatory Affairs Consultant in the healthcare industry, with a focus on US regulations;
In-depth knowledge of US FDA regulations and guidelines for drug and medical device development and approval processes;
Exceptional research, analytical, and problem-solving skills;
Excellent written and verbal communication skills;
Assistant Director Of Regulatory Affairs
By NC Real Estate Commission At West Bend, NC, United States

Attorney needed to assist division director with supervisory and managerial responsibilities and to prosecute cases involving allegations of violations of Real Estate License Law and Commission ...