- Cipla (Fall River, MA)
- …- 5:00 PM (may vary based on business needs) Reports To : Packaging Manager Pay Range: $78,000 - $99,840 Purpose: InvaGen Pharmaceuticals, Inc. is searching for ... ensures compliance with cGMP's, InvaGen Pharmaceutical's policies,standard operating procedures, and FDA requirements. The incumbent will serve as a key resource… more
- Cipla (Fall River, MA)
- …the safe and efficient execution of their job duties, while ensuring product compliance to established standards. Essential Duties and Responsibilities : Responsible ... cGMP policies, documentation and record keeping in accordance with industry and FDA standards and Safety and sanitation regulations. Performs a combination of manual… more
- Cipla (Hauppauge, NY)
- …- 5:00PM (may vary based on business needs) Reports To : QA Validation Manager Salary Range: $68,000 - $74,600 Purpose: The incumbent to this role performs and ... and facilities and utilities associated with pharmaceutical manufacturing and drug product development. Job Overview Responsible for the coordination of supportive… more
- Regeneron Pharmaceuticals (Sleepy Hollow, NY)
- … regulatory landscape. + Counseling on all aspects of product commercialization, including launch preparation, launch execution, market development, disease ... law. Possess a solid understanding of the biotech/pharmaceutical industry, including product development, commercialization, and the legal and regulatory … more
- Actalent (Lake Forest, CA)
- …global medical device regulations (eg, FDA CFR, EU MDR). Skills Regulatory , new product development, quality, 510(k), Project management, engineering, MDR, ... Description We are seeking an experienced and strategic Regulatory Affairs Manager to support global...surveillance, FDA , CFR, CFRA Top Skills Details Regulatory ,new product development,quality,510(k) Additional Skills & Qualifications… more
- Schwan's Company (Minneapolis, MN)
- …Qualified Individual (PCQI), providing expert guidance on regulatory requirements, product safety, labeling compliance (USDA/ FDA ), and special claims to ... excellence across the supply chain? As our Sr Manager , FSQ Regulatory Compliance, you will play...regulatory expert, and manage complex compliance programs including product safety, labeling, import/export, and crisis management. If you… more
- Boehringer Ingelheim (St. Joseph, MO)
- **Description** Manager The Manager , Regulatory Affairs (RA) Pharma Safety & Efficacy will represent the US regulatory safety and efficacy function in ... project team meets US requirements in development activities. The manager will be responsible for FDA meetings...accordance with the project governance model to drive Target Product Profile objectives. + Provides consistent regulatory … more
- Globus Medical, Inc. (Audubon, PA)
- …can resume their lives as quickly as possible. **Position Summary** **:** The Manager , Regulatory Affairs, is responsible for preparing, filing and gaining ... team in preparing and filing 510(k), IDE, PMA submissions, FDA reports, all international regulatory submissions and...systems and line extensions. + Assists in review of product labeling and marketing materials. + Provides regulatory… more
- Dentsply Sirona (Milford, DE)
- …for mentoring and providing guidance to their direct reports and cross-functional product development teams on US and EU regulatory requirements. This ... regulatory guidance and support to cross-functional teams throughout the product lifecycle. Reviews and interprets regulatory requirements and guidance… more
- CSL Behring (King Of Prussia, PA)
- …to actively contribute to an innovative, scientifically sound, global, integrated regulatory vision/strategies for assigned product /s with a patient-centric ... insights and applying prudent risk-taking to ensure timely delivery of successful regulatory outcomes. Effectively partner with assigned product /s Global … more
