Regulatory Affairs Project Manager
BioTalent
A growing manufacturer of consumer and personal care products is seeking a Regulatory Manager to help drive product innovation while ensuring regulatory compliance across the business. This role combines Regulatory Affairs and Project Management, partnering with Product Development, Quality, Operations, Supply Chain, and leadership teams to support products from concept through commercialization. What You'll Do Lead regulatory compliance activities for new and existing products, ingredients, formulations, and packaging Review product labels, claims, and technical documentation to ensure compliance with applicable regulations Monitor regulatory changes and evaluate potential impacts to products and business operations Partner with Product Development, Quality, and Operations teams to support innovation and manufacturing initiatives Manage regulatory projects, timelines, and cross-functional priorities Support ingredient assessments, supplier documentation reviews, and technical evaluations Assist with product scale-up, manufacturing transfers, and commercialization activities Develop and improve regulatory processes, documentation practices, and compliance workflows Supervise and mentor a direct report What We're Looking For 5+ years of experience in Regulatory Affairs, Product Development, Quality, or a related function Experience within cosmetics, personal care, OTC, consumer health, pharmaceutical, food, or other regulated industries Working knowledge of FDA regulations, cGMPs, ingredient compliance, product claims, and labeling requirements Strong project management skills with experience leading cross-functional initiatives Ability to evaluate technical information and communicate effectively with diverse stakeholders Strong organizational, leadership, and problem-solving skills Bachelor's degree in a scientific, technical, or related discipline preferred Why Join? Growing organization investing in innovation, product expansion, and operational growth High-impact role with broad visibility across multiple functions Opportunity to help shape regulatory strategy, processes, and future team development Mission-driven culture focused on quality, responsible practices, and long-term sustainability Collaborative, team-oriented environment with strong work-life balance #J-18808-Ljbffr
- ...Senior Project ManagerOnsite: 3 days a week (Wednesday and Thursday required)Working directly... ...of the IT portfolio, the Senior Project Manager will execute project management for... ...our clients. This role will focus on the Regulatory portfolio as well as other projects. As...Suggested3 days per week
$99k - $232k
.../SectorNot ApplicableSpecialismFraud, Investigations & Regulatory Enforcement (FIRE)Management LevelManagerJob Description & SummaryThe OpportunityAs... ...planning and mentoring junior staff. You are accountable for project success and maintaining standards, motivating and...SuggestedFull timeContract workFor contractorsH1b- Job-ID31521196Reference25-04484 The Global Regulatory Affairs (GRA) is responsible for obtaining approval for new products and ensuring that... ...authorities and the program teams aiming to ensure that the project plan correctly anticipates what the regulatory authority...Suggested
- ...Reference25-04665 Responsibilities: The Regulatory Manager (RM) provides regulatory strategy and... ...guidance documents, providing analysis to project teams, as well as supporting and... ...as representative of Global Regulatory Affairs at project team meetings with both external...SuggestedFlexible hoursNight shift
- ...Solutions team This role develops regulatory strategies for existing, new,... ...) products This role manages and submits 510ks for the products... ...for less senior Regulatory Affairs professionals, including but... ...submissions and managing regulatory projects In-depth knowledge of FDA 510...SuggestedWork at office
- ...reporting and data integrity across U.S. and international sites. The successful candidate will bring 12+ years in pharma/compliance, strong project management, and excellent communication skills to advance automation, data governance, and program #J-18808-Ljbffr sarepta
$185k - $235k
...ensures adherence to internal standards, contractual obligations, regulatory requirements, and industry best practices. This is a highly... ...Assurance and Internal Operational Standards Vendor Management and Contract Compliance Corporate Ethics and Business Conduct...Contract workSummer workWork at officeImmediate startWorldwideOverseas3 days per week- ...needs. Each client is supported by a dedicated nurse and case manager, ensuring compassionate, personalized, and dignified care.As Vitra... ...and a genuine mandate to shape how the organization manages regulatory excellence.The Director of Compliance leads the compliance...Work from home
- Partner closely with the Director of Regulatory Affairs to define and implement regulatory strategies for new product development, product modifications, and lifecycle management of Class II medical devices. Provide regulatory guidance during product development to ensure...
- A medical device company in Cambridge, MA, is seeking a Regulatory Affairs professional to lead regulatory strategies for Class II medical devices. Responsibilities include managing FDA submissions, ensuring regulatory compliance throughout product development, and collaborating...
$321.4k - $370k
...annual compliance work-planning process to identify and prioritize regulatory, billing, privacy, operational, financial, and business-... ...corrective-action plans are implemented and monitored. Advises senior management regarding appropriate remediation and disciplinary action for...Full timeFor contractorsFixed term contractFlexible hours- ...Reporting to the Chief Operating Officer, you will translate organizational priorities into effective day-to-day execution, support managers, monitor performance, and drive continuous improvement across aging and disability services. #J-18808-Ljbffr Somerville-Cambridge...Work from home
- ...healthcare organization (HCO)network opertaions, sales, and account management to deliver cohesive growth across all market segments.... ...Intelligence & Competitive Positioning : Monitor industry trends, regulatory developments, and competitive dynamics across the global life...Local area
- ...across drug development, manufacturing, and commercialization. You will lead scalable QMS and governance, collaborate with CMC, Regulatory, Clinical Operations, and Supply Chain, and ensure compliance with global regulations to protect patient safety and data integrity...
$210k - $245k
...ensuring our products meet all applicable regulatory, safety, and quality standards across... ...Partner closely with engineering, product management, manufacturing, quality, legal, and go-... ...compliance, safety engineering, or regulatory affairs, including leadership experience in a...Full timeWork at officeRelocation- Philips is hiring a Regulatory Affairs leader in Cambridge, Massachusetts, focusing on strategic regulatory leadership for software-enabled medical devices. The role involves developing regulatory strategies, guiding new product introductions, and ensuring compliance with...
$175k - $200k
Chief Compliance Officer opening located at a Boston asset management firm I’m a Senior Recruiter at Fanning- Masis. I assist my client... ...testing, monitoring and annual reviews, preparing and submitting regulatory SEC filings, and the like. This role is a FANTASTIC...$114k - $177k
...Nursing Officer, Establish accreditation/regulatory preparation process and implement to... ...presents programs based on employee and management request and assessments. 2.2. Conduct... ...organizations. 3.5.Supervise and manage special project activities. 4. Serves as CSHC’s...Work at officeFlexible hours- ...audit us. Lumafield’s Quality Leader will own the Quality Management System across all of Lumafield: design and development planning... ...: Serve as the primary point of contact for customer audits, regulatory body inspections, and internal quality assessments. Act as...Full timeWork at officeFlexible hours
$232k - $348k
Job DescriptionThe Regulatory Strategy Senior Director is a regulatory leader... ...strategy for multiple and/or complex projects in development (from first-in-... .... Counsels and advises senior management on status of global Regulatory Affairs strategies and tactics, procedures...Full timeSummer workWork at officeLocal areaRemote workFlexible hours2 days per week3 days per week$196.7k - $353.4k
...is seeking a Sr. Director of Regulatory Strategy to support oncology... ...strategic leader within Regulatory Affairs, responsible for developing... ...and amendments.Advises project teams regarding the development... ...additional data, organizes and manages participation in meetings....Permanent employmentFull timeWork at officeWork from home$185.6k - $278.4k
...DescriptionGeneral Summary:The Regulatory Labeling Director will lead... ...development and lifecycle management of labeling for that/those area... ...work, teamwork, and projects related to regulatory labeling... ...of experience in regulatory affairs in the area of global labeling...Full timeSummer workWork at officeLocal areaRemote workFlexible hours2 days per week$218.06k - $327.09k
Job Title: Senior Director, Regulatory Affairs Strategy - Cell Therapy Available locations: Gaithersburg... ...driven choices.Delivery and Milestone Management: Oversee all regulatory deliverables... ...and technology, and contribute to non-project initiatives that advance how we work...Hourly payFull timeTemporary workStart working todayWork at officeFlexible hours3 days per week- ...is compliant with all relevant laws and regulatory requirements.The CCO is responsible for... ...completing an enterprise-wide risk assessment, manage risk ranking and prioritization, and... ...transportation policies and projects for the Commonwealth of Massachusetts and...Full timePart timeWork experience placement
- ...Observatory in Cambridge, MA, seeks a Director of Human Resources to lead HR strategy, modernization, and compliance onsite. You will manage Federal and non-Federal (Trust) hiring, immigration programs, and HR analytics across SAO sites, advancing workforce planning and...
$80k - $120k
...protocol to ensure accuracy of documentation. Document Production/Management: Adhere to document production timelines to ensure efficiency... ...maintain legal documents, including research and contracts. Project Management: Manage multiple clients and projects...Temporary workWork at officeLocal areaVisa sponsorshipWork visaFlexible hours$268.2k - $402.2k
...Summary:The Executive Director, Regulatory Strategy will serve as a... ...portfolio. This position will manage a group of global/regional regulatory... ...strategy for multiple projects in development (from FIH to post... ...status of global Regulatory Affairs strategies and tactics,...Full timeSummer workLocal areaRemote workFlexible hours2 days per week$200k - $265k
...impact.The OpportunityLeads the global regulatory strategy, submission planning, and health... .... Accountable for the Global Regulatory Affairs team supporting nemolizumab and for driving... ...risksCore member of Nemluvio Global Project Team, provide regular updates to leadership...Full timeTemporary workWork experience placementWork at officeWorldwide$170k - $267.5k
...technology-enabled, and aligned with applicable regulatory expectations across jurisdictions. The... ...investors rely on us to help them manage risk, respond to challenges, and drive performance... ...regulatory risks.Coordinate with project managers to deliver requirements for...Full timeTemporary workFlexible hours- ...years professional experience in legal, regulatory, compliance environments; attorneys with... ...preferred5+ years in end-to-end allegations management programs including intake/triage, case... ...organizational and project management skills, with ability to drive...ApprenticeshipWork at office
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