Senior Regulatory Affairs Associate

The purpose of this role is to execute OTC regulatory activities for new product registrations and life-cycle and maintenance for the portfolio of products defined by the US Business Units.Key Responsibilities:Represent USRA on assigned projects, provide guidance on OTC drug regulatory pathways (monograph, NDA).Develop regulatory strategies and documents for new product launches and maintenance of current products, aligned with the regulationsDevelop a regulatory label for OTC products, review claims and copyParticipate in the review of promotional materialsSupport end-to-end regulatory compliance of products in remit.Applies system and procedure updates to maintain up to date technical product recordsIdentifies and participates in process improvements within US Regulatory AffairsInteract with colleagues in other global functions to support global programsEffectively communicates regulatory technical requirements and guidelines, facilitating timely and complete submissionsDevelop up-to-date knowledge of guidelines and regulatory requirements, as well as technical trendsQUALIFICATIONSBachelor's degree in Pharmaceutical or Life Sciences or equivalent regulatory experience2-4 years' experience in regulatory affairs including chemistry, manufacturing and controls, and over the counter experience, preferably within a CPG/Consumer Healthcare/Pharma related industry.Experience and knowledge in Quality, product development and manufacturing areas.Experience working on FDA applications, OTC monograph products, chemistry, manufacturing and controlsProficient knowledge in US FDA regulations