- embecta (Parsippany, NJ)
- …+ Demonstrated success in the preparation and completion of 510(k) and EU MDR regulatory submissions to FDA and EU notified bodies. + International product ... diverse and global employees. This position will be responsible for providing regulatory strategies and execution on embecta growth initiative projects. The role… more
- Sanofi Group (Morristown, NJ)
- …CMC strategies, conduct risk assessments, and serve as the primary liaison with regulatory authorities including FDA and EMA. You'll collaborate across R&D, ... **Job Title:** Global Regulatory Affairs CMC lead **Location:** Framingham, MA, Morristown,...+ Act as direct liaison with agencies like US FDA and EMA + Develop positive relationships with regulators… more
- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- …development and change control, ensuring compliance with US, EU, and other global regulatory requirements. + Author FDA submissions (eg, 510(k), Q-Sub), EU ... compliance. + Serve as a point of contact for FDA , EU Notified Bodies, and other regulatory ...for FDA , EU Notified Bodies, and other regulatory agencies regarding submissions and related issues. + Independently… more
- AbbVie (Florham Park, NJ)
- …influence, and provide strategic advice. Serves as strategic liaison with the regulatory agencies (eg, FDA ) regarding CMC matters. Scope of Responsibility: ... Tik Tok (https://www.tiktok.com/@abbvie) . Job Description The Associate Director Regulatory Affairs, Chemistry, Manufacturing and Controls (CMC) works with internal… more
- Parexel (Trenton, NJ)
- …Consultant level role, 7+ years for a Senior Consultant * Proven success in preparing regulatory documentation for FDA , EMA, and Health Canada (IND, NDA, DMF) * ... experienced and highly motivated professional to join our Global Regulatory Affairs team as a CMC Regulatory ...Global Regulatory Affairs team as a CMC Regulatory Affairs Senior/Consultant. This role is critical to ensure… more
- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- …performance of all products. Provides clinical expertise in submissions and communication with FDA and other Regulatory authorities around the world as needed. + ... ideation, concept development, product verification, and validation, legal and regulatory compliance, demonstration of product value, and stakeholder education. In… more
- Terumo Medical Corporation (Somerset, NJ)
- …labeling requirements across US and international markets and ensures compliance with FDA , Terumo, and global regulatory standards. The Senior Labeling ... + Ensure full compliance with US Food and Drug Administration ( FDA ) regulations, international regulatory requirements, company policies, operating procedures,… more
- Kelly Services (Burlington, NJ)
- …compliance team, establish standards from the ground up, and ensure adherence to FDA and other regulatory frameworks. You'll collaborate closely with Quality ... with stakeholders during strategic planning. + Lead notifications regarding regulatory changes affecting operations. + Oversee responses and communication with… more
- Bausch Health (Bridgewater, NJ)
- …of current Good Manufacturing Practices (GMP), Food and Drug Administration ( FDA ), and regulatory pharmaceutical marketing and manufacturing principles, ... + Collaborate cross-functionally with Trade Operations, Supply Chain, Finance, Quality, Regulatory Affairs, and Commercial teams to ensure alignment and issue… more
- Oracle (Trenton, NJ)
- …of Technical Staff to play a critical technical leadership role to ensure FDA and global regulatory compliance, including secure design, architecture and ... Risk-Based Process and ensure product is maintaining compliance to FDA and other Global regulatory requirements. -...maintaining compliance to FDA and other Global regulatory requirements. - Proficiency in the Java programming language.… more