- Monitor, interpret, and ensure compliance with local, national, and international regulations and standards pertinent to our industry.
- Develop and implement regulatory strategies to support product development, registration, and marketing
- Oversee the preparation, review, and submission of regulatory documents, including but not limited to, applications, notifications, and reports required for product approval and maintenance.
- Maintain comprehensive regulatory files and databases to support regulatory submissions and
- Collaborate closely with internal departments such as Research & Development, Quality Assurance, and Marketing to integrate regulatory considerations into business processes and product development
- Provide regulatory guidance and support to project teams to ensure regulatory requirements are met throughout the product life cycle.
- Stay abreast of changes in regulatory requirements, guidelines, and best practices, and communicate relevant updates to internal stakeholders.
- Assess the impact of regulatory changes on existing products and processes and recommend appropriate actions to maintain compliance.
- Serve as the primary point of contact for regulatory agencies and notified bodies, representing the company in regulatory interactions, submissions, and audits.
- Build and maintain positive relationships with regulatory authorities to facilitate timely approvals and resolve regulatory issues.
- Conduct risk assessments to identify and mitigate regulatory risks associated with product development, manufacturing, and distribution activities.
- Implement and maintain robust regulatory risk management processes and
- Bachelor's degree in a relevant scientific or technical discipline; advanced degree
- Minimum of 5 years of experience in regulatory affairs within the pharmaceutical, medical device, biotechnology, or related industry.
- In-depth knowledge of regulatory requirements and guidelines applicable to the company's products and
- Proven track record of successful regulatory submissions and
- Strong analytical, problem-solving, and decision-making
- Excellent communication, interpersonal, and leadership
- Ability to work effectively in a fast-paced, dynamic environment and manage multiple priorities
- Certification in Regulatory Affairs (e.g., RAC) is a plus
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Regulatory Affairs Manager
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Octapharma AG New York, United StatesTab drücken, um zum Link "Weiter zu Inhalt" zu gelangen · Wählen Sie aus, wie oft (in Tagen) Sie eine Benachrichtigung erhalten möchten: · Wählen Sie aus, wie oft (in Tagen) Sie eine Benachrichtigung erhalten möchten: · Regulatory Affairs Manager (m/w/d) - befristet bis März 2026 ...
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Regulatory Manager
Found in: Lensa US 4 C2 - 3 days ago
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Regulatory Manager
Found in: Lensa US 4 C2 - 3 days ago
Force Brands New York, United StatesTHIS IS NOT A ROLE WITH FORCEBRANDS · This position requires being on-site in SoHo every Tuesday, Wednesday, and Thursday. · Responsibilities: · Regulatory Compliance: Ensure compliance with local, national, and international regulations and standards, while developing and exe ...
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regulatory manager
Found in: beBee S2 US - 2 weeks ago
SBH Fashion New York, United States PermanentDigitally Native, high growth skincare brand is seeking a highly skilled and experienced Regulatory Manager. The Regulatory Manager will be responsible for ensuring compliance with all relevant regulations, standards, and guidelines governing our industry. They will oversee regul ...
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Regulatory Compliance Manager
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Regulatory Compliance Manager
Found in: Lensa US 4 C2 - 1 day ago
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Regulatory Compliance Manager
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Regulatory Policy Manager
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Regulatory Audit Manager
Found in: Lensa US 4 C2 - 4 days ago
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Regulatory Risk Manager
Found in: Lensa US 4 C2 - 1 week ago
ING New York, United States Full timeRisk | Trading Risk Management (TRM) | Regulatory Risk Manager | Location · About ING: · Ranked #8 on LinkedIn Top Companies in Financial ServicesCrain's 100 Best Places to Work · Ragan's Top Places to Work in 2023 · In Americas, ING's Wholesale Banking division offers a broad r ...
Regulatory Manager - New York, United States - Bubble Skincare
Description
Reporting to: VP of ProductDepartment: Product Full Time/Salaried
Salary Range:$110-130K
Location: This position is based in our New York City office, 3 days a week in the SOHO Office
Position Overview:
We are seeking a highly skilled and experienced Regulatory Manager to join our team. The Regulatory Manager will be responsible for ensuring compliance with all relevant regulations, standards, and guidelines governing our industry. They will oversee regulatory affairs, provide strategic guidance to internal teams, and interface with regulatory authorities as necessary to maintain compliance and facilitate product approvals.
Key Responsibilities:
Regulatory Compliance: