Regulatory Affairs Director oversees regulatory matters and executes the strategy to ensure the organization complies with applicable regulations. Develops processes and systems to ensure that all necessary licensing, filings, certifications, and permits are processed and monitored. Being a Regulatory Affairs Director establishes monitoring policies and procedures to ensure compliance with existing regulations. Anticipates new or changing regulations and coordinates with internal stakeholders to develop strategies to address changes in product, operations, or testing requirements. Additionally, Regulatory Affairs Director investigates and addresses any reported issues of non-compliance. Requires a bachelor's degree. Typically reports to a director. The Regulatory Affairs Director typically manages through subordinate managers and professionals in larger groups of moderate complexity. Provides input to strategic decisions that affect the functional area of responsibility. May give input into developing the budget. To be a Regulatory Affairs Director typically requires 3+ years of managerial experience. Capable of resolving escalated issues arising from operations and requiring coordination with other departments. (Copyright 2024 Salary.com)
**Job Summary:**
We are seeking a dynamic and experienced Director of Pharmaceutical Operations to oversee our drug company's daily operations and drive business growth. The ideal candidate will possess strong leadership skills, strategic thinking, and a proven track record in FDA regulated operations management.
**Duties:**
- Lead and manage the overall operations of drug and cosmetic manufacturing , ensuring efficiency and effectiveness in all processes.
- Develop and implement strategies to optimize operational performance, achieve business objectives and maintain FDA compliance .
- Collaborate with senior leadership to set strategic goals and drive business development initiatives.
- Oversee day-to-day activities, including process improvement, resource allocation, and performance monitoring.
- Negotiate contracts with vendors, suppliers, and partners to ensure cost-effective operations.
- Drive continuous improvement through strategic planning, project management, and operational excellence.
**Qualifications:**
- Minimum 10 years supervisory management experience in an FDA regulated manufacturing company.
-Bachelor's degree in Business Administration, Engineering or related field;
- Proven experience in senior leadership roles with a focus on operations management.
- Strong background in process improvement, strategic planning, and project management.
- Excellent negotiation skills with the ability to build strong partnerships.
- Demonstrated ability to lead cross-functional teams and drive operational excellence.
This is an outstanding opportunity for a results-driven professional with a passion for operational excellence. If you are ready to take on a challenging yet rewarding role as a Pharmaceutical Director of Operations, we invite you to apply and be part of our dynamic team.
Job Type: Full-time
Pay: $96,097.00 - $107,195.00 per year
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Work Location: In person