Regulatory Affairs Senior Associate

Job TitleRegulatory Affairs Senior AssociateLocationWarren, NJ 07059 (HYBRID, Onsite or 3 days in officeDuration6 Months (Possibility of extension depending upon business requirements and performance)Shift8-5Description:The purpose of this role is to execute OTC regulatory activities for new products registrations and life-cycle maintenance for the portfolio of products defined by the US Business Units.Key Responsibilities:These responsibilities include some of the following.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 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 trendsQualifications:Bachelor's degree in Pharmaceutical or Life Sciences or equivalent regulatory experience2-4 years' experience in regulatory affairs including chemistry, manufacturing and controls, and over thecounter 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 regulationsRegulatory Affairs Senior AssociateExcellent communications skills, stakeholder management and enjoys working in multidisciplinary teamsAbility to manage prioritize projects of high complexityExperience leading end-to-end regulatory process in new product launchesAdditional Preferred Qualifications:Knowledge and experience of US regulatory framework for OTC drugs, OTC medical devicesAbility to ensure compliance standards and key performance indicators are metRegulatory expertise in knowledge of the regulatory lifecycleAbility to interact at many levelsTechnical knowledgeMinimum 2 years of experience in regulatory affairsCompetencies and Skills:Agile, attention to detail, written and verbal communication skills– using evidence and applying judgement to balance pace, rigor and riskApplicant Notices & DisclaimersFor information on benefits, equal opportunity employment, and location-specific applicant notices, click hereAt SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position's starting pay is: $45.00/hr.