Regulatory Compliance Specialist - Apex Systems

Job#: 2025403

Job Description:

Regulatory Compliance Specialist
Growing pharmaceutical company is expanding their team with a Regulatory Compliance Specialist.  We have a dynamic team and positive culture!
We are seeking a results-driven Regulatory Compliance Specialist to implement and develop regulatory compliance strategies. You will be reviewing documentation and procedures, collaborating with internal and external stakeholders on compliance-related issues, and performing compliance audits.
Responsibilities: 

• Reviewing documentation, processes, and practices.
• Developing and enacting regulatory compliance strategies.
• Coordinating regulatory compliance procedures across organizational structures.
• Providing training in compliance practices and procedures.
• Monitoring compliance and facilitating interventions to manage risks.
• Performing compliance audits and compiling reports.
• Documenting compliance-related processes and maintaining records.
• Keeping abreast of regulatory changes and developments in the regulatory environment.
• Monitor USDA/FDA/NOP regulations and ensure company compliance with all and any regulating bodies.
• Product certifications (i.e., Non-GMO, OK Kosher, Organic, etc…)
• Working knowledge of 21 CFR 111
• Knowledge of FDA-CFR reference, regulatory compliance of certification programs including Organic, Non-GMO Project Verified, and OK Kosher, understanding of current regulatory and legal issues.
• Other duties may be assigned as needed.

Requirements

• 5+ years of experience working in the Regulatory Compliance industry.
• Extensive knowledge of industry regulations and governing laws.
• Proficiency in office and compliance management software.
• Exceptional analytical, investigative, and organizational skills.
• Excellent interpersonal and communication skills

Benefits

• Annual Bonus
• Paid Time Off (PTO);
• Company covered health, dental, vision, and life insurance
• 5% 401(k) match plus an additional 4%
• Wellness Credit
• Employee store credit
• Company sponsored events
• Fun team-building activities.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

EEO Employer

Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at [email protected] or 844-463-6178.