GSMS, Incorporated
Sr. Manager Regulatory & Compliance
GSMS, Incorporated, Camarillo, California, United States, 93012
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Sr. Manager Regulatory & Compliance
role at
GSMS, Incorporated 1 month ago Be among the first 25 applicants Join to apply for the
Sr. Manager Regulatory & Compliance
role at
GSMS, Incorporated This range is provided by GSMS, Incorporated. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more. Base pay range
$106,300.00/hr - $140,000.00/hr Sr. Manager, Regulatory & Compliance
Summary
The Sr. Manager, Regulatory & Compliance will ensure all GSMS facilities and business entities maintain full compliance with all applicable federal and state regulatory requirements and guidelines for the manufacture, storage, distribution, marketing and sales of GSMS’ products and services. The Sr. Manager, Regulatory & Compliance will work with federal, state, and local regulatory agencies on registrations, licenses, and reporting related to GSMS’ products and services. The Sr. Manager, Regulatory & Compliance will assist the VP Quality & Compliance with the design, administration, and maintenance of GSMS’ Corporate Compliance Plan, Code of Conduct, and associated Compliance Policies & Procedures.
Experience
Bachelor’s degree with a minimum 10 years of experience in pharmaceutical regulatory & compliance operations, and 2 years of Supervisory experience required.
General Duties And Responsibilities
Manage federal registrations, licenses, and regulatory reporting to FDA, DEA, and other applicable federal agencies. Manage US State licenses and applicable state reporting for pharmaceuticals, controlled substance, price transparency, etc. as required by state regulations. Responsible for the oversight and management of GSMS contracted state registered agents. Responsible for management and oversight of GSMS National Drug Code (NDC) directory. Responsible for management and oversight of GSMS Structured Product Labeling (SPL) Responsible for Regulatory & Compliance professional certifications and memberships, such as National Association of Boards of Pharmacy (NABP), Pharmaceutical Product Stewardship Work Group (PPSWG), etc. Responsible for the design, implementation, and maintenance of GSMS Regulatory Intelligence Framework to ensure continued compliance with new federal and state regulations and regulatory trends. Develop, implement, and maintain policies and procedures related to new GSMS business opportunities to ensure compliance with applicable federal and state regulations. Responsible for GSMS corporate compliance and healthcare compliance programs for items such as ethics, fraud, anti-kickback, conflict of interest, HIPPA, US federal Sunshine Act, state disclosure, etc Responsible for the compliance and accuracy of GSMS promotional activities and materials. Create, execute, and monitor GSMS Compliance Training Program, including the development of role-based training curriculum and training content. Assists the VP Quality and Compliance with the design, administration, and maintenance of GSMS Corporate Compliance Plan, Code of Conduct, and associated Compliance Policies & Procedures. Responsible for the execution of the Corporate Compliance Committee under oversight of the VP Quality & Compliance. Responsible for ensuring Compliance Policies and Procedures are compliant and up to date with applicable regulations. Own and execute GSMS Corporate Audit Program to ensure compliance with all applicable regulations and corporate policies/procedures. Provide supervision, coaching, development and performance reviews for corporate regulatory/compliance staff Participates in special projects and performs other duties as assigned.
Required Qualifications
In-depth understanding of the pharmaceutical industry with expertise in the body of laws and regulations impacting pharmaceutical companies. Knowledge of federal & state regulatory requirements concerning the manufacture, storage, and distribution of pharmaceuticals and dietary supplements. Knowledge of current FDA regulations for NDC’s, SPL’s, GDUFA, Cares Act and related reporting requirements. Expertise with healthcare industry laws and regulations, including the U.S. Physician Payments Sunshine Act, False Claims Act and Anti-kickback Statute Excellent written and verbal communication skills for both internal management and external organizations such as regulatory agencies and customers. Ability to read, analyze, and interpret regulations, legal documents, technical journals, clinical and medical terminology, and complex documents. Excellent analysis and problem-solving skills Excellent organizational skills with extreme attention to detail Ability to multi-tasking is essential for this position. Ability to lead and manage complex projects. Ability to partner effectively Strong ability to influence Self-motivated and goal-driven Ability to work in a team environment. Proficient in Microsoft Office applications
Miscellaneous Requirements
Must be able to pass screening, drug test and background check. Adhere to company’s drug-free workplace policies. Maintain a strong attendance record
Seniority level
Seniority level Not Applicable Employment type
Employment type Full-time Job function
Job function Legal Industries Pharmaceutical Manufacturing Referrals increase your chances of interviewing at GSMS, Incorporated by 2x Sign in to set job alerts for “Senior Regulatory Manager” roles.
Quality Control Regulatory Compliance Senior
Moorpark, CA $65,000.00-$100,000.00 2 weeks ago We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
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Sr. Manager Regulatory & Compliance
role at
GSMS, Incorporated 1 month ago Be among the first 25 applicants Join to apply for the
Sr. Manager Regulatory & Compliance
role at
GSMS, Incorporated This range is provided by GSMS, Incorporated. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more. Base pay range
$106,300.00/hr - $140,000.00/hr Sr. Manager, Regulatory & Compliance
Summary
The Sr. Manager, Regulatory & Compliance will ensure all GSMS facilities and business entities maintain full compliance with all applicable federal and state regulatory requirements and guidelines for the manufacture, storage, distribution, marketing and sales of GSMS’ products and services. The Sr. Manager, Regulatory & Compliance will work with federal, state, and local regulatory agencies on registrations, licenses, and reporting related to GSMS’ products and services. The Sr. Manager, Regulatory & Compliance will assist the VP Quality & Compliance with the design, administration, and maintenance of GSMS’ Corporate Compliance Plan, Code of Conduct, and associated Compliance Policies & Procedures.
Experience
Bachelor’s degree with a minimum 10 years of experience in pharmaceutical regulatory & compliance operations, and 2 years of Supervisory experience required.
General Duties And Responsibilities
Manage federal registrations, licenses, and regulatory reporting to FDA, DEA, and other applicable federal agencies. Manage US State licenses and applicable state reporting for pharmaceuticals, controlled substance, price transparency, etc. as required by state regulations. Responsible for the oversight and management of GSMS contracted state registered agents. Responsible for management and oversight of GSMS National Drug Code (NDC) directory. Responsible for management and oversight of GSMS Structured Product Labeling (SPL) Responsible for Regulatory & Compliance professional certifications and memberships, such as National Association of Boards of Pharmacy (NABP), Pharmaceutical Product Stewardship Work Group (PPSWG), etc. Responsible for the design, implementation, and maintenance of GSMS Regulatory Intelligence Framework to ensure continued compliance with new federal and state regulations and regulatory trends. Develop, implement, and maintain policies and procedures related to new GSMS business opportunities to ensure compliance with applicable federal and state regulations. Responsible for GSMS corporate compliance and healthcare compliance programs for items such as ethics, fraud, anti-kickback, conflict of interest, HIPPA, US federal Sunshine Act, state disclosure, etc Responsible for the compliance and accuracy of GSMS promotional activities and materials. Create, execute, and monitor GSMS Compliance Training Program, including the development of role-based training curriculum and training content. Assists the VP Quality and Compliance with the design, administration, and maintenance of GSMS Corporate Compliance Plan, Code of Conduct, and associated Compliance Policies & Procedures. Responsible for the execution of the Corporate Compliance Committee under oversight of the VP Quality & Compliance. Responsible for ensuring Compliance Policies and Procedures are compliant and up to date with applicable regulations. Own and execute GSMS Corporate Audit Program to ensure compliance with all applicable regulations and corporate policies/procedures. Provide supervision, coaching, development and performance reviews for corporate regulatory/compliance staff Participates in special projects and performs other duties as assigned.
Required Qualifications
In-depth understanding of the pharmaceutical industry with expertise in the body of laws and regulations impacting pharmaceutical companies. Knowledge of federal & state regulatory requirements concerning the manufacture, storage, and distribution of pharmaceuticals and dietary supplements. Knowledge of current FDA regulations for NDC’s, SPL’s, GDUFA, Cares Act and related reporting requirements. Expertise with healthcare industry laws and regulations, including the U.S. Physician Payments Sunshine Act, False Claims Act and Anti-kickback Statute Excellent written and verbal communication skills for both internal management and external organizations such as regulatory agencies and customers. Ability to read, analyze, and interpret regulations, legal documents, technical journals, clinical and medical terminology, and complex documents. Excellent analysis and problem-solving skills Excellent organizational skills with extreme attention to detail Ability to multi-tasking is essential for this position. Ability to lead and manage complex projects. Ability to partner effectively Strong ability to influence Self-motivated and goal-driven Ability to work in a team environment. Proficient in Microsoft Office applications
Miscellaneous Requirements
Must be able to pass screening, drug test and background check. Adhere to company’s drug-free workplace policies. Maintain a strong attendance record
Seniority level
Seniority level Not Applicable Employment type
Employment type Full-time Job function
Job function Legal Industries Pharmaceutical Manufacturing Referrals increase your chances of interviewing at GSMS, Incorporated by 2x Sign in to set job alerts for “Senior Regulatory Manager” roles.
Quality Control Regulatory Compliance Senior
Moorpark, CA $65,000.00-$100,000.00 2 weeks ago We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
#J-18808-Ljbffr