What are the responsibilities and job description for the Quality and Regulatory Director position at Garonit Pharmaceutical?
Summary
This position is full-time located in the Fairfield, NJ office. Some travel will be required. The job involves leadership of Quality Control, Quality Assurance, and Regulatory Affairs. This position will also be involved in our Global business development program. This position reports to the President and also work closely with corporate leadership.
Responsibilities
Quality Control / Assurance
Manage 15 - 20 employees
Hire required staff and build robust team
Develop and implement quality policies, procedures, and objectives to ensure goals are achieved
Develop and implement industry-specific quality standards to ensure compliance with customer and regulatory requirements
Lead and manage the Quality Assurance and Quality Control team
Utilize statistical analysis to identify opportunities for improvement in processes
Analyze and report on quality metrics, trends, and performance
Establish and maintain relationships with customers, vendors, and regulatory bodies to ensure adherence to standards
Monitor supplier performance and evaluate supplier auditing processes
Serve as a liaison between the organization and external parties
Develop and implement quality training programs
Regulatory Affairs
Manage and monitor preparation, submission and review of regulatory documentation in collaboration with all regulatory filings (DMF / ANDA / NDAs / PDMA / CEP)
Act as an in-house regulatory expert, advising and supporting, all countries associated with Garonit Pharmaceuticals (NA, Europe, and Japan)
Lead the implementation of global regulatory strategies taking into consideration the overall development program objectives.
Provide regulatory support to our global customers. Proactive leadership that supports our customers.
Business Development
o Monitor process for new product development
o Plan and review all Finished Dosage Filings
o Involved in procurement of ANDA / NDA’s
Qualifications
Strong working experience with a variety of regulatory authorities is required, with real firsthand experience of managing registrations with different regulatory authorities
Must have experience in preparing and filling ANDA , NDA application with US FDA
Experience in leading and managing complex / virtual networks suppliers and partners to deliver and maintain regulatory approvals is essential
Proven track record in influencing and shaping optimal quality and regulatory outcomes
Experience with FDA and other regulatory authorities
Proven ability to work effectively in a team environment
Professional experience as part of a regulatory agency would be useful
Excellent knowledge of Quality and Regulatory environment (ICH, different regulatory mechanisms and authorities, GCP, GLP and GMP)
Education & Experience
Bachelor’s degree in science (Master’s in discipline would be preferred).
Minimum 12 years’ quality and regulatory experience in the pharmaceutical industry
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