Confidential
Vice President, Quality Assurance & Regulatory Affairs
Confidential, Tarrytown, New York, United States, 10591
Vice President, Quality Assurance & Regulatory Affairs
About the Company
Globally recognized provider of over-the-counter healthcare products
Industry Consumer Goods
Type Public Company
Founded 1996
Employees 501-1000
Specialties
otc healthcare products medical devices otc healthcare products
About the Role
The Company is seeking a Vice President for Quality Assurance and Regulatory Affairs to ensure the compliance and safety of its diverse product portfolio, which includes OTC monograph drugs, OTC NDAs, medical devices, cosmetics, dietary supplements, and EPA-registered products. The successful candidate will be responsible for designing, implementing, and monitoring effective compliance strategies that align with the company's business goals. This role involves leading medical affairs activities, fostering close relationships with various functions within the company, and maintaining a strong presence in global regulatory and quality developments. The VP will also be tasked with confirming the cGMP compliance of third-party contract manufacturers and providing clear direction on clinical studies, customer contact center, and pharmacovigilance.
Applicants for the VP position must have a Bachelor's degree in a scientific or health-related field, with a Master's degree preferred, and a minimum of 20 years of experience in quality assurance and/or regulatory affairs within the CPG industry. The role requires a candidate with a solid background in OTC healthcare quality and regulatory affairs, including strong knowledge of US OTC NDA, monograph drug, and medical device regulatory requirements. Experience in NDA or 510(k) submission and maintenance, as well as a proven track record of supervising a team for over 10 years, is essential. The ideal candidate will have excellent communication skills, the ability to work effectively with people, and a strong understanding of global regulatory requirements, particularly in Canada, the EU, and Latin America.
Hiring Manager Title Chief Executive Officer
Travel Percent 20%
Functions
Operations
About the Company
Globally recognized provider of over-the-counter healthcare products
Industry Consumer Goods
Type Public Company
Founded 1996
Employees 501-1000
Specialties
otc healthcare products medical devices otc healthcare products
About the Role
The Company is seeking a Vice President for Quality Assurance and Regulatory Affairs to ensure the compliance and safety of its diverse product portfolio, which includes OTC monograph drugs, OTC NDAs, medical devices, cosmetics, dietary supplements, and EPA-registered products. The successful candidate will be responsible for designing, implementing, and monitoring effective compliance strategies that align with the company's business goals. This role involves leading medical affairs activities, fostering close relationships with various functions within the company, and maintaining a strong presence in global regulatory and quality developments. The VP will also be tasked with confirming the cGMP compliance of third-party contract manufacturers and providing clear direction on clinical studies, customer contact center, and pharmacovigilance.
Applicants for the VP position must have a Bachelor's degree in a scientific or health-related field, with a Master's degree preferred, and a minimum of 20 years of experience in quality assurance and/or regulatory affairs within the CPG industry. The role requires a candidate with a solid background in OTC healthcare quality and regulatory affairs, including strong knowledge of US OTC NDA, monograph drug, and medical device regulatory requirements. Experience in NDA or 510(k) submission and maintenance, as well as a proven track record of supervising a team for over 10 years, is essential. The ideal candidate will have excellent communication skills, the ability to work effectively with people, and a strong understanding of global regulatory requirements, particularly in Canada, the EU, and Latin America.
Hiring Manager Title Chief Executive Officer
Travel Percent 20%
Functions
Operations