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Regulatory Affairs Manager - Permanent - Bridgewater, NJ. Proclinical is seeking a Manager, Regulatory Affairs for a global medical device company. Responsible for developing and implementing global regulatory strategy and roadmaps through deep understanding of the competitive market landscape, regulatory / legislative initiatives, and product marketing strategy for product portfolio.
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Collaborate with Sales, Medical Affairs, Regulatory Affairs, and other cross-functional teams to ensure seamless execution of marketing initiatives. Minimum 12 years experience in pharmaceutical marketing, Women’s Health experience highly preferred.
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Job Title: PV Liaison Senior Manager (USA), Regulatory affairs Location: Candidate must go to NJ, Bridgewater office 2-3 times a week. Responsibilities PV Liaison Senior Manager (USA): o Supports the CSH in all PV related activities at the country level, including but not limited to management of cases, periodic safety reports, activities of local vendor, safety surveillance of marketed products, audits / inspections, compliance of Local Pharmacovigilance, PV Regulatory Intelligence and PV awareness training.
ExpandApply NowActive JobUpdated 24 days ago - UpvoteDownvoteShare Job
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Leads regional and global product safety and regulatory affairs projects to simplify, harmonize and streamline processes and procedures. Participates in meetings and provides necessary support towards completing the Product Safety and Regulatory Affairs check list.
$94,300 a yearFull-timeExpandApply NowActive JobUpdated 1 month ago - UpvoteDownvoteShare Job
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Work with cross functional departments such as manufacturing, AR&D, validation, QC/QA and regulatory affairs to meet critical milestones of the projects. Generate product development documents in support of regulatory submissions.
Full-timeExpandApply NowActive JobUpdated 19 days ago - UpvoteDownvoteShare Job
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This investigation includes but is not limited to a criminal, civil litigations and regulatory review, employment, education, and credit review (role dependent). We assist companies and non-profit organizations in delivering benefits to their employees.
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The SEC Reporting and Technical Accounting Manager will need to coordinate well with others and proactively keep up with the latest regulatory developments that impact the Company’s SEC filing and financial reporting requirements.
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Supports Product Quality Complaint Managers/Director during FDA, regulatory, third party, and internal audits. Provides complaint support to other company departments including Customer Service, Medical Information, Pharmacovigilance, Sales Associates, Regulatory, Commercial Operations, Legal, and Risk Management.
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Conduct comprehensive research on ESG trends, regulatory frameworks, and best practices across various industries in support of sustainability strategy and related initiatives; deliver decision-useful information to senior management and provide valuable insights to our program.
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Build relationships with legal, medical affairs, regulatory affairs to ensure appropriate review of marketing pieces and compliance with marketing guidelines. Manage and drive forward launch planning activities for new products including goal setting, timeline and milestone development, leadership over cross functional team meetings across multiple stakeholders (including commercial, market access, manufacturing, regulatory, legal, investor relations, corporate communications), gain alignment across team members, track and provide critical updates to team, and mitigate risks.
Full-timeExpandApply NowActive JobUpdated 23 days ago - UpvoteDownvoteShare Job
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Minimum 5 years in Regulatory Affairs, including leadership roles. Ensure effective execution for new innovative consumer-centric products and the life cycle management of products in the portfolio across the following regulatory classes (OTC monograph drugs, dietary supplements, cosmetics, foods and medical devices.
$95.7 - $110.7ExpandApply NowActive JobUpdated 3 months ago - UpvoteDownvoteShare Job
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Coordinate recipe development from product concept to launch stage whilst ensuring compliance to safety, regulatory, internal policies & quality requirement. As the MRM Recipe Specialist you will support new recipe development for the Vitamins, Minerals and Supplements brands.
$35 an hourRemoteExpandApply NowActive JobUpdated 1 month ago - UpvoteDownvoteShare Job
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We’re excited to announce that we’re hiring a Nutrition Science Intern to join our Global Scientific and Regulatory Affairs (GSRA) Department for the summer of 2024! G2M training: develop training materials to educate the internal stakeholders about the definition, scientific standard of substantiation, and regulatory landscape of postbiotic products.
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Under the direction of the Director, Health and Wellness, this position is responsible for routine communication with direct care staff, medication aides, other nursing staff, the Director, Health and Wellness, and the Administrator about the needs of residents and maintaining compliance with all regulatory standards.
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The role will interface with multiple cross-functional teams including pharmacovigilance, quality, medical directors/leads, field medical team, commercial, regulatory, legal, and clinical development as well as external partners.
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regulatory affairs jobs Company: Mallinckrodt Pharmaceuticals in Bridgewater, Beech-grove, Indiana
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