- Cardinal Health (Waukegan, IL)
- …products and develops plans for product development programs and regulatory submissions . **_Responsibilities_** + Under direction of manager , support new and ... applies subject matter expertise to provide services in technical writing and regulatory submissions as well as clinical research and manufacturing process… more
- Boehringer Ingelheim (Ridgefield, CT)
- …the planning and execution of regulatory submissions coordinated by the Regulatory Project Manager . + Support submission rollout for Rest of World (RoW) ... among team members, encourage cross-functional coordination and coordinate with the (senior) regulatory project manager to achieve regulatory milestones &… more
- Dana-Farber Cancer Institute (Boston, MA)
- …group's Clinical Research Manager in their resolution + Manage the regulatory documentation submissions that may include the preparation and submission of ... the CTIP Associate Director for the Pediatric unit, the Regulatory Operations Manager (ROM) will oversee the... Regulatory coordinators) is responsible for closely managing regulatory submissions and communication process, following a… more
- Globus Medical, Inc. (Audubon, PA)
- …and filing 510(k), IDE, PMA submissions , FDA reports, all international regulatory submissions and registrations, responds to questions, and achieves timely ... can resume their lives as quickly as possible. **Position Summary** **:** The Manager , Regulatory Affairs, is responsible for preparing, filing and gaining… more
- AbbVie (Irvine, CA)
- …enable first pass approvals. Develops and manages content strategy for regulatory submissions , including INDs/CTAs and amendments, new marketing applications ... + Prepares device regulatory product strategies. Prepares and manages regulatory submissions , including new applications and amendments, renewals annual… more
- Dentsply Sirona (Waltham, MA)
- …for medical devices and other regulated products globally. + Leads and manages regulatory submissions , including 510(k) submissions , and technical files for ... preferably in the medical device industry. + Experience with leading regulatory submissions and managing regulatory projects. + In-depth knowledge of… more
- Boehringer Ingelheim (Ridgefield, CT)
- …reflect Boehringer Ingelheim's high regard for our employees. The Associate Director, Regulatory Project Manager delivers project management support to the ... upon regulatory strategy, timeline and deliverables. The Associate Director, Regulatory Project Manager creates and updates critical path for submission,… more
- Taiho Oncology (Princeton, NJ)
- …and support the preparation, review, and submission of all components of regulatory submissions as assigned, including INDs and amendments, CTAs, marketing ... annual reports, safety reports, etc. + Support planning and executing regulatory submissions requiring cross-functional collaboration and alignment. + Prepare,… more
- J&J Family of Companies (Titusville, NJ)
- …Johnson & Johnson Innovative Medicine R&D is recruiting for a Manager , Regulatory Scientist. This position is a hybrid role ... NJ; Spring House, PA; or San Diego, CA. The Manager , Regulatory Scientist is a regulatory...leading meetings. + Assist in strategy development by researching regulatory and medical information in preparing submissions … more
- Otsuka America Pharmaceutical Inc. (Raleigh, NC)
- …pharmaceutical and/or healthcare industry. - Knowledge and experience with preparation of global regulatory submissions (IND, CTA, NDA or BLA, MAA). - RAC ... planning and execution of global investigational and marketed prescription drug submissions and manages lifecycle regulatory activities in alignment with… more
- Ascendis Pharma (Palo Alto, CA)
- …of Global Regulatory Affairs, providing project management leadership to key global regulatory submissions across the Ascendis pipeline. As a part of the ... for employees to grow and develop their skills. The Regulatory Project Manager will be an integral...in the end-to-end planning, coordination, and execution of assigned Regulatory submissions project deliverables. + Monitor submission… more
- Stryker (Mahwah, NJ)
- …for new product launches, ensuring alignment with business objectives. + Manage regulatory submissions for market access, including 510(k), PMA, and ... **Senior Manager , Regulatory Affairs - Joint Replacement...to maintain compliance. + Ensure accuracy and completeness of submissions , labeling, and marketing materials to meet regulatory… more
- Otsuka America Pharmaceutical Inc. (Augusta, ME)
- …CMC requirements. + Plan, prepare, and review CMC sections of regulatory submissions (IND/IMPD/NDA/MAA, post-approval supplements). Determine regulatory ... global submissions , and post-marketing lifecycle management as the CMC Regulatory lead. + Regulatory experience in handling-controlled substance applications… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …objectives for the assigned products or projects. You will typically lead the Regulatory Submissions Teams associated with assigned products or projects and ... plans. + Leads the preparation, compilation, and timely filing of regulatory submissions , which require cross-functional interactions for commercial or… more
- Grifols Shared Services North America, Inc (Clayton, NC)
- …holders/ distributors / regulatory authorities the information required and prepare regulatory submissions to be used worldwide for all marketed products. + ... all disciplines to assure appropriate testing and documentation are generated for regulatory submissions and routine import documentation. Prepare personnel from… more
- Astellas Pharma (Northbrook, IL)
- … Excellence** + Leads the development, implementation and successful application of robust regulatory strategy input to assigned areas for submissions such as ... variations) across assigned development projects and/or commercial products. Assures submissions reflect the best-in-class application of regulatory standards… more
- Abbott (Alameda, CA)
- …cross-functional teams as the regulatory SME, provide support for compiling regulatory submissions , and ensuring data is effectively presented for the ... for diversity, working mothers, female executives, and scientists. **The Opportunity** This ** Regulatory Affairs Manager - APAC** position will work on-site at… more
- Abbott (Pleasanton, CA)
- …and apply regulatory requirements. Compile, prepare, review and submit regulatory submissions to authorities. + Domestic and international regulatory ... executives, and scientists **The Opportunity** We are seeking a ** Regulatory Affairs Manager ** to join Abbott's Heart...with EU and other international medical device regulations and submissions . + Ability to work in a highly matrixed… more
- Abbott (Lake Forest, IL)
- …will: + Coordinate preparation of well organized, complete and scientifically sound regulatory submissions . + Interface directly with various regulatory ... for diversity, working mothers, female executives, and scientists. **The Opportunity** The **Sr. Regulatory Affairs Manager ** hired in this role will work out of… more
- Olympus Corporation of the Americas (Westborough, MA)
- … due diligence in vendor and technology selection. + Oversee and support regulatory submissions and compliance filings where applicable (eg, AI risk ... software engineering practices is desirable. + Experience with 510(k), De Novo submissions , CE marking, and international regulatory pathways for Software as… more