Act as Local Contact Person for Pharmacovigilance for the designated country.
Assume leadership and functional representation for projects of medium/high complexity ensuring effective and rapid coordination and management of regulatory deliverables.
Foster professional working relationships with internal and external contacts at the local and international levels to ensure smooth and efficient service delivery.
PrimeVigilance, part of Ergomed Group, is a specialized mid-size pharmacovigilance service provider established in 2008. They provide first class support to their small to large pharmaceutical and biotechnology partners maintaining long lasting relationships and has become one of the global leaders in its field.
Serve as the Subject Matter Expert (SME) for unit-specific safety challenges.
Analyze metrics to identify trends and implement sustainable corrective actions.
Lead HSE initiatives using the Plan–Do–Check–Act (PDCA) cycle.
Sodexo improves the quality of life for those they serve and contribute to the economic, social, and environmental progress in the communities where they operate. They achieve this by providing food service, catering, facilities management, and other integrated solutions worldwide, valuing diversity and inclusion.
Providing strategy based on regulatory requirements.
Completing regulatory and PV deliverables based on established plan.
Acting as Local Contact Person for Pharmacovigilance for designated country.
PrimeVigilance, part of Ergomed Group, is a specialized mid-size pharmacovigilance service provider established in 2008. They provide first class support to their small to large pharmaceutical and biotechnology partners and value employee experience, well-being and mental health.
Set submission strategy and operational timelines.
Build, evolve, and manage the Regulatory Operations infrastructure.
Establish and oversee training on RA procedures and submission standards.
Mineralys Therapeutics is a clinical-stage biopharmaceutical company focused on developing medicines to target hypertension and related comorbidities. Mineralys is a fully remote company.
Serve as a subject-matter expert on global clinical and regulatory writing projects
Lead the writing, review, and coordination of complex documents such as CTD Modules, Clinical Study Protocols, and Clinical Study Reports
Drive development of key clinical documents that align with overall program and submission strategy
Jobgether is a company that uses AI-powered matching to ensure applications are reviewed quickly, objectively, and fairly. Their system identifies the top-fitting candidates and shares this shortlist directly with the hiring company.
Lead trade compliance for Thermal Ceramics globally.
Make sure the business moves quickly while staying on the right side of export controls, sanctions, and customs rules.
Shape policies, influence senior leaders, and work with global regulators.
Morgan Advanced Materials makes high-performance materials that keep extremely hot, extremely fast or extremely sensitive things working safely. Thermal Ceramics is one of its global businesses, looking for someone who knows international trade compliance inside out.
Serve as a subject matter expert on all Occupational Health & Safety related topics.
Identify and provide guidance to direct reports to build a high-performance team.
Collaborate across multiple domains to enhance existing integrations and processes.
Remote is designed to solve modern organizations’ biggest challenge–navigating global employment compliantly with ease. The company enables businesses of all sizes to recruit, pay, and manage international teams and has a future-focused work culture.
Collaborate with client teams to understand products and create regulatory strategies.
Implement strategies by engaging regulatory authorities and authoring submissions.
Proactively influence the regulatory environment to achieve business goals.
EVERSANA provides next-generation commercialization services to the life sciences industry, serving over 650 clients from biotech startups to established pharmaceutical companies. They have a global team of more than 7,000 employees committed to creating a healthier world by bringing innovative therapies to market and supporting patients.
Own and evolve the company’s product safety and risk management framework.
Proactively identify safety and compliance risks associated with dietary ingredients and formulations.
Translate complex risk and safety topics into clear, actionable guidance.
Nutrafol pioneers clinically tested products for hair growth, supporting people at every step of their hair journey. They target key root causes of hair thinning using a patented blend of standardized vitamins, minerals and natural ingredients. They are recommended by over 7,500 physicians and hair professionals.
Lead regulatory compliance projects from initiation through completion.
Interpret new and evolving regulations and translate them into actionable project plans.
Oversee regulatory audits, assessments, and remediation activities.
SGS is the global leader in inspection, verification, testing and certification services. With over 97,000 employees in 130 countries, they provide services to almost every industry assuring quality and safety of products and services, fostering innovation and welcoming new ideas.
Serve as Global Regulatory Lead for the Phase 3 HCM program.
Provide strategic regulatory input and leadership at program governance forums and core team meetings.
Plan, prepare, review, and oversee submissions to regulatory authorities supporting late-stage development and registration readiness.
Braveheart Bio is a Bay Area–based biopharmaceutical company pioneering best-in-class therapies for cardiovascular disease. With a proven leadership team, a strong financial foundation, and a high-value late-stage asset, they represent an outstanding opportunity for ambitious, mission-driven professionals.
Improve clients' Regulatory Information Management processes.
Work collaboratively with diverse teams to drive business value.
Enhance efficiency and compliance for clients in a rapidly evolving landscape.
Jobgether uses an AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements. Their system identifies top-fitting candidates, and this shortlist is then shared directly with the hiring company.
Serve as the enterprise Inspection Readiness Leader by defining strategy, policies, standards, governance frameworks, roles, responsibilities, escalation pathways, and operating models across all ARI sites and functions.
Design, implement, and sustain a standardized enterprise inspection readiness program, including lifecycle models for pre-inspection, active inspection, and post-inspection phases.
Provide enterprise-level oversight of inspection readiness posture, assess site readiness maturity using risk-based criteria and inspection indicators, and identify systemic inspection risks requiring enterprise remediation.
American Regent, Inc., a Daiichi Sankyo Group Company, is a top-10 injectable manufacturer, developing, manufacturing, and supplying high-quality generic and branded injectables. They have locations in New York, Ohio, and California and sales territories nationwide and have been in business for over 50 years.
Provide regulatory compliance risk assessment and consultation.
Assist financial services clients in strengthening their compliance management systems.
Conduct regulatory compliance testing for federal consumer compliance regulations.
Wipfli provides accounting and consulting services. Their people are the core of their business, and they focus on relationships while encouraging individuals to follow their own path.
Partner with product and marketing teams to ensure compliance with consumer protection regulations.
Monitor and analyze new and evolving regulatory requirements, assessing their impact on products.
Manage and develop a team of compliance professionals by setting clear expectations.
EarnIn is a pioneer of earned wage access, building products that deliver real-time financial flexibility for those with the unique needs of living paycheck to paycheck. It is a fast-growing company with experienced leadership and world-class funding partners.
Accountable for the regulatory inventory, regulatory compliance products library for Pismo and DPS Products.
Monitor regulatory environments assisting your product teams in finding and understanding changes in regulations through new legislation, changes in guidance and examiners' manuals.
Working with Product on new and improved features and products research and identify regulations, review them for applicability by working with product, legal, and others.
Pismo, founded in 2016, provides a comprehensive processing platform for banking, card issuing and financial market infrastructure. With 500+ employees across 10 countries, they help clients innovate and transition from legacy systems to advanced technology, maintaining high security and availability standards.
Serves as a dedicated strategic partner to assigned operational or functional business areas.
Translates business needs and regulatory expectations into effective, practical, and inspection-ready learning solutions.
Accountable for shaping learning approaches that support business outcomes, regulatory compliance, and inspection readiness.
Vertex Pharmaceuticals is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious diseases. They employ scientists, business professionals, and researchers united around a common goal–to discover, develop, and deliver innovative medicines.
Serve as a strategic document partner for assigned functional areas, aligning document development and records management with business, quality, and regulatory expectations
Conduct document impact and needs analyses and supports the functional document hierarchy which integrates the development, maintenance, and distribution of critical documents that support the organization’s strategic goals and initiatives
Leverage automation, digital tools, and emerging technologies, including AI and Machine Learning, to optimize documentation processes and content
Vertex is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious diseases. They have sites in North America, Europe, Australia, Latin America and the Middle East and are consistently recognized as one of the industry's top places to work.
Global Regulatory Lead for a cutting edge RPT programs
Clinical and nonclinical regulatory strategy for therapeutic and diagnostic (imaging) products
Lead the preparation and submission of regulatory filings
RayzeBio, a wholly-owned subsidiary of Bristol Myers Squibb, develops transformative radiopharmaceutical therapies. They blend the spirit of an emergent biotech with the expertise and resources of a leading innovator in oncology, fostering a multidisciplinary team where ideas are valued.