Senior Regulatory Affairs - Princeton, United States - Diverse Lynx

Description

Hi,Welcome to Diverse Lynx We combine industry leading expertise and our personal dedication to help you find your next career opportunity.

We are a Minority and Women Owned Business Enterprise (MWBE) certified by the State of New Jersey and Minority Business Enterprise (MBE) certified from National Minority Supplier Development Council.

Established in 2002, we have helped thousands of candidates find their next role.

Diverse Lynx is headquartered in Princeton, NJ and have exclusive job opportunities with Fortune companies in USA, Canada, United Kingdom, and India.

We would love to speak with you and help get connected with the hiring team for this role.

Benefits/Perks Competitive CompensationFlexible work models (Remote, Hybrid, Onsite)Career Growth OpportunitiesExclusivity on all roles meaning your resume will be personally reviewed by hiring managersLong Term ContractsMedical BenefitsPlease go through below opening we have with one of our leading global professional services firm delivering outcomes that transform business and shape the future.

Kindly review the details and let me know if you would like to apply and further discuss.


Title:
Senior Regulatory Affairs (RA)

ManagerType:
ContractDuration: 6 monthsLocation: Los Angeles, CA, 90020(Onsite, atleast 3 day onsite)

About the role:

The Senior Regulatory Affairs Manager ensures regulatory compliance of clients cosmetic, OTC, dietary supplement, and device products from brief through launch in North America.

Specifically, the Sr.

Manager will assemble and review all product-related information including formulas, specifications, and quality/regulatory compliance documentation, and for approving claims, labeling, and advertising.

Communicate emerging regulations to key stakeholders and their impact client's portfolio in NA.


Required:
7-10 years' Experience RequiredRoles & ResponsibilitiesParticipate in project teams in assigned categories to ensure completion of appropriate documents during the development process through final formula approval and launchMaintain and ensure compliance with client ingredient policies and appropriate product regulationsEnsure claims are compliant with client and local regulatory requirements and consistent across labels, advertising, and other consumer communicationsReview and approve NA artworksResponsible for US regulatory submissions, including FDA drug and establishment registrations, supplement notifications, WERCS and EPA and state pesticide registrationsAssist monitoring US state and federal regulations impacting the cosmetic and personal care industry including OTCSupport with upcoming changes in the regulations including any specific monitoring and implementation for states, e.g., CaliforniaPreferred QualificationsOnsite 3 days per weekBilingual English/Korean preferredMinimum QualificationsScientific degreeOver 8 years of Regulatory Affairs experience within a regulated industry, preferably skin and personal care products including OTCProduct development experience strongly preferredSkin and personal care including OTC claim review experience strongly preferredTrack record adhering to compliance requirements (i.e.

FDA, Health Canada, EPA, FTC, cGMP, ISO, etc.)Strong written communication skills, especially detail oriented and technical materialExperience communicating with cross-functional teams and customers including verbal presentationsAbility to work effectively both independently and as part of a teamAbility to meet deadlines while being flexible to changes in priorities and interruptionsExcellent organizational and analytical skills to complete assignments accuratelyFull usability of MS Office suite (Excel, Word, Outlook, PowerPoint)Diverse Lynx LLC is an Equal Employment Opportunity employer.

All qualified applicants will receive due consideration for employment without any discrimination.

All applicants will be evaluated solely on the basis of their ability, competence and their proven capability to perform the functions outlined in the corresponding role.

We promote and support a diverse workforce across all levels in the company.#J-18808-Ljbffr