Job Information
Freyr Inc Regulatory Affairs Managers in Princeton, New Jersey
Develop and implement regulatory marketing strategies to support market penetration, lead generation, and conversion for new business products. Support participation in regulatory conferences, client meetings (in-person or virtual), and networking activities within the life sciences industry. Oversee materials and documentation for discussions with domestic or international regulatory agencies. Support account management activities including tracking client requirements, coordinating project deliverables, and ensuring business continuity. Contribute to proposal and RFP processes for large and mid-size biopharmaceutical clients by providing research support, preparing documentation, and coordinating internal reviews. Track and report progress toward revenue and project goals under the guidance of senior management. Oversee regulatory submissions, reports, and correspondence to ensure accuracy and compliance with standards. Support cross-functional teams with regulatory guidance, documentation, and quality control during product development and marketing stages. Prepare weekly summaries or reports on business development activities and client engagement status. Contribute to the execution of operational plans for the business unit. Monitor and summarize emerging trends or regulatory changes. Provide support for regulatory consulting activities. Identify opportunities for process optimization, efficiency improvement, and technology-based solutions within life sciences programs. Support global market expansion efforts by coordinating product registration activities, maintaining documentation, and liaising with consultants or local partners as required. Gain exposure to regulatory application types and perform life cycle maintenance documentation. Conduct regulatory assessments and gathering information for consulting projects involving global expansion requirements. Support initiatives related to AI or technology implementation in regulatory processes. Coordinate tasks on complex programs under senior supervision, assisting in stakeholder communication and project tracking. Audit preparation, regulatory inspections, or documentation for product recalls as needed. Monitor and document activities to ensure compliance with sustainability, quality, and corporate standards. Maintain up-to-date knowledge of regulatory requirements, guidelines, and industry best practices. Identify potential project risks and mitigation planning. Require Bachelor’s degree in Regulatory Affairs, Biochemistry/Biomedical Sciences or related field of study with 5 years’ experience in the job offered or related occupation. Experience in: Develop account penetration plan; conduct market surveys; process deployment; identify and minimize gaps (continuous reinforcement, motivation); sales and marketing data analysis; identify sales trends; performance gaps; develop training manual; conduct training programs; market segmentation; SWOT analysis; product development; and project budgeting. Relocation and travel to various unanticipated locations within USA possible.