Human Resources Compliance Specialist

Job Overview
We are seeking a proactive and detail-oriented Human Resources Compliance Specialist to join our dynamic team. In this vital role, you will oversee and ensure adherence to all relevant pharmaceutical and biomedical regulatory standards, including FDA regulations, EMA guidelines, ICH (International Council for Harmonisation) guidelines, and ISO standards specific to our location. Your expertise will drive compliance management projects, support regulatory submissions, and uphold the highest standards of quality assurance across our research and manufacturing operations. This position offers an exciting opportunity to influence our compliance strategies, streamline processes, and contribute to the integrity of our biomedical and pharmaceutical initiatives.

Duties

• Develop, implement, and maintain comprehensive compliance programs aligned with FDA regulations, EMA regulations, ICH guidelines, and other relevant health regulation policies.
• Lead regulatory compliance analysis by reviewing clinical trials data, chemistry, manufacturing & controls documentation, and drug regulation protocols to identify potential risks or gaps.
• Prepare and coordinate regulatory submissions for FDA approvals, amendments, and renewals while ensuring accuracy and timeliness.
• Manage cross-functional communication with research teams, quality assurance departments, legal advisors, and external regulatory bodies to facilitate seamless compliance workflows.
• Conduct internal audits and risk assessments to monitor adherence to pharmaceutical regulatory compliance standards; develop corrective action plans as needed.
• Utilize compliance management software to track ongoing projects, document findings, and generate detailed reports for senior management review.
• Stay current on evolving health regulation policies such as ISO, EMA regulations, and other international standards to ensure ongoing compliance across all operations.

Qualifications

• Bachelor’s degree in life sciences, pharmacy, chemistry, or a related field; advanced certifications in regulatory affairs or compliance management are preferred.
• Proven experience working with FDA regulations, clinical trials oversight, pharmaceutical regulatory compliance, or biomedical regulatory compliance.
• Strong understanding of drug regulation processes including regulatory submissions and ICH guidelines.
• Excellent data analysis skills with proficiency in compliance management software tools; experience with risk management frameworks is advantageous.
• Familiarity with ISO standards and EMA regulations relevant to biomedical research or manufacturing environments.
• Exceptional writing skills for preparing detailed reports, documentation for regulatory submissions, and policy updates.
• Effective project management abilities with a track record of leading complex compliance projects across cross-functional teams.
• Strong knowledge of health regulation policies combined with excellent communication skills to facilitate collaboration at all organizational levels.

Pay: $52,336.78 - $63,029.24 per year

Benefits:

• 401(k)
• 401(k) matching
• Employee assistance program
• Flexible schedule
• Health insurance
• Health savings account
• Retirement plan
• Vision insurance

Work Location: Remote

Salary : $52,337 - $63,029