Regulatory Affairs Associate
Connecting Talent 2 Opportunity
Regulatory Affairs AssociateAs a Regulatory Affairs Associate you will:Gain experience and exposure to groundbreaking programs and strategies for compounds in development and/or marketing products intended to address unmet medical needs in markets globally. Learn the laws, guidance, and regulatory requirements for drugs and combination products while being accountable to the organization's objectives. Accountability is the cornerstone of our culture. We demonstrate our compassion for patients and work hard to honor our commitment to those who depend on us to develop innovative therapies.Support innovative thinking and contribute to fresh innovative solutions in Regulatory Affairs. Innovation is our passion and mission as well as a fundamental requirement in our pursuit to create world-class medicines.Develop leadership and creative problem-solving skillsets, to become an inventive regulatory leader in the healthcare field of interest.As part of the two-year experiential regulatory leadership program, all Associates complete a project for presentation to the GRA Senior Leadership Team and other internal partners.QualificationsEarned a bachelor's degree (B.S. or B.A.) from a 4-year University degree program in science, technology, or an engineering-related field. Examples include biomedical engineering, data analytics/applied statistics, quantitative modeling in biology, pharmacy, or other healthcare science. A strong academic track record is required.Some fundamental understanding of pharmaceutical drug development. Knowledge of current Food and Drug Administration (FDA) regulations, guidelines, and submission requirements are desired.Proven leadership capabilities in an organizational setting (campus/community activities) are desired.Able to work independently, as well as, be part of a group, with curiosity and flexibility.Be self-motivated, possess a "can do" approach, and courage to speak your voice and suggest innovative ideas.Be a creative problem solver, with an interest in exploring the international context of healthcare systems and technology contexts.
- ...financial flexibility by offering contingent labor as a variable cost.Job DescriptionThis individual will be part of the Global Regulatory Affairs team and assists with planning, writing, compilation, and editing of periodic regulatory reports (i.e. DSURs, orphan annual...SuggestedWork at officeImmediate start
- ...internal and external cross-functional project teams.• The Regulatory CMC Technical Associate may be called upon to author technical reports.• The... ...s Degree a plus• 4+ years of pharmaceutical regulatory affairs experience• Strong knowledge of NDA, ANDA, MAA, BLA, CTA...SuggestedWork at officeLocal areaImmediate start
$148k - $170k
...on patients' lives.Reporting StructureReports To: Director, Regulatory Affairs - Advertising, Promotion, and LabelingDirect Report(s): NoneAreas... ...marketed products across one or more therapeutic areas. The Associate Director provides strategic guidance to commercial, medical,...SuggestedNight shiftWeekend work- ...Description Our client, a global pharmaceutical, biotechnology, and medical technology company, is actively looking for a Regulatory Affairs Project Manager to join their team! This role is 100% remote however they are only considering candidates currently on the...SuggestedContract workRemote work
$28.5 - $35 per hour
...compliance with state and federal regulations. Responsibilities include oversight of sample collection, development and review of regulatory reports, and assistance in the implementation of new environmental compliance initiatives. The ideal candidate should have...SuggestedHourly payTemporary workWork at officeLocal areaMonday to Friday- ...education and professional development. Summary of the Role We are looking for an experienced and dynamic Permitting & Regulatory Compliance Specialist II to join our growing team. In this role you will independently manage a defined caseload of permitting and...Work at officeImmediate startRemote workFlexible hours
$92k - $148.35k
...our employees and recognize their merit. Job Function Regulatory Affairs Group Job Sub Function Regulatory Affairs Job Category... ..., as well as to provide routine regulatory information to associates and affiliates. Advises on regulatory labeling...Local areaImmediate startRemote work- Why Messer? Messer is the world’s largest privately held industrial gases company and what we do matters because it is woven into every part of life, from the medical gases that patients rely on to the essential elements needed to safely and sustainably produce the goods...Permanent employmentFull timeTemporary work
$90k - $118k
...assessment, reconciliation, governance, and business analytics initiatives that drive operational excellence, transparency, and regulatory compliance.Key ResponsibilitiesWork closely with business and functional analysts to develop functional and technical requirements...Full timeTemporary workWork at officeLocal areaRelocation package3 days per week- ...performance, this is an exciting opportunity to support the growth of the captive reinsurance business, become an expert in the Bermuda regulatory framework, and gain exposure across a variety of risks and markets.Location: This role will be based in Hamilton, Bermuda....Full timeWork at officeRelocation package3 days per week
$86.58k - $123.3k
...patients and consumers. POSITION OVERVIEW: The Senior Regulatory Operations Specialist is an experienced individual contributor... ...global regulatory submissions. The role works with Regulatory Affairs, content owners, technology teams, and external providers to...Remote work- Clinical Data Analyst IIIContractCompany DescriptionIRI believes in commitment, integrity and strategic workforce solutions.Integrated Resources, Inc., is led by a seasoned team with combined decades in the industry. We deliver strategic workforce solutions that help you...
- R3 Technology Inc. seeks Clinical Data Analyst for its Hillsborough, NJ office. Participate in clinical trial data management processes. Conduct data analysis, visualization, and data modeling based on report design in clinical data models, including ambulatory, laboratory...Work at officeRelocation
$40 - $42 per hour
Location: Bridgewater, NJ Salary: $40.00 USD Hourly - $42.00 USD Hourly Description: Our client is currently seeking a Data Analyst II The CX Insights and Engagement Team designs and implements a best-in-class Voice of the Customer (VOC) program to drive customer...Hourly payWork experience placement$135k - $180k
...tracking schedule to complete on time.• Provide a quality project while minimizing unbudgeted change orders.• Manage interface with regulatory agencies to ensure compliance with adopted environmental, life safety and technical code references.• Organize required internal...Full timeContract workTemporary workFor contractors$110k - $146k
Why Messer? Messer is the world’s largest privately held industrial gases company and what we do matters because it is woven into every part of life, from the medical gases that patients rely on to the essential elements needed to safely and sustainably produce the goods...Full timeTemporary workFor contractors$154.38k - $193.13k
Job DescriptionPrincipal - Business Consulting (SAP Program Manager)About UsDo you want to boost your career and collaborate with expert, talented colleagues to solve and deliver against our clients' most important challenges? We are growing and are looking for people to...Full timeTemporary workLocal areaRemote work$58.77k - $85.72k
...Customs, broker, planners, management, etc. Additional duties as assigned. Qualifications ~ Bachelor’s degree preferred; Associate’s degree required. ~1-3 years of experience required in data analysis and Customs related functions. ~ Knowledge and...Work experience placement- ...Regulatory Affairs Manager Job DescriptionManage Company's Regulatory Affairs for assigned products for US and Canada, including implementation of the overall regulatory strategy, preparation of regulatory submissions and interface with relevant health authorities.Implement...
- Job TitleBus.Key ResponsibilitiesRecognize business problems and recommends/develops reporting solutions in Domo platformWork with business users to gather requirements, translate to technical requirements and build front end visualizations to meet business needsDesigns...
$110k - $146k
Why Messer? Messer is the world's largest privately held industrial gases company and what we do matters because it is woven into every part of life, from the medical gases that patients rely on to the essential elements needed to safely and sustainably produce the goods...Temporary workFor contractors$94k - $151.8k
...subject to legal requirements including consultation with works councils and other employee representative bodies, as may be required, regulatory approvals and other customary conditions and approvals. It is anticipated following conclusion of the transaction, you would be...Local areaImmediate startRemote work- ...contingent labor as a variable cost. Job Description The Regulatory Affairs Operations (RA Ops) submission group is organized to provide... ...filing dates are impacted. Coordinate publishing tasks associated with assigned submissions, including peer review of...Immediate start
- Job Description Required Skills 8 Plus Years’ experience as Technical Project Manager, Communication and Data experience Responsibilities Leads customer engagement to ensure that it meets all scope, time, budget and quality expectations, through planning, controlling and...
- ...General Affairs Associate The General Affairs Associate ensures smooth day-to-day office operations by managing facilities, procurement, assets, vendors, and administrative services. This role maintains a safe, efficient, and compliant workplace while coordinating internal...Work at officeLocal area
$86.9k - $121.88k
...endovascular and hybrid technologies, we enable physicians to find the right fit for each patient anatomy.The company has over 1,250 associates around the world with manufacturing facilities in Glasgow, Scotland and Sunrise, Florida.Terumo Aortic is focused on the...Contract workTemporary workLocal areaImmediate startWorldwideFlexible hours$110k - $146k
...tracking schedule to complete on time.Provide a quality project while minimizing unbudgeted change orders.Manage interface with regulatory agencies to ensure compliance with adopted environmental, life safety and technical code references.Organize required internal activities...Full timeTemporary workFor contractorsNight shift$164.01k - $228.78k
...collaboration between the various specialists, within the PTC and across R&D Units, Technical and Business Units, IP and Global Regulatory and with external partners. Including launching markets and agencies for consumer testing.Contribute to training in project management...Work at office- Job ID: z5G7h3l6a1kMvyS65NP3c67RqrsZUyVW2GmXgFr-FdI=Job Code: VDart-2026-J5559Location: Raritan, NJ, 08869, United StatesContact: Vinothini Subramaniyan SRole: OMP Project Manager with Supply ChainLocation: Raritan, NJ (Remote)Exp: 10+ YearsMandatory Skills : OMP - Planning...Remote work
- ...clinical practices (ICH) and thorough understanding of current regulatory requirements (FDA, EMEA) related/ applicable to the conduct of... ...communicate and collaborate with project teams, departmental associates, internal and external partners.Demonstrated ability to anticipate...Immediate startRemote work2 days per week
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