What Does a Regulatory Specialist Do?
A regulatory specialist ensures that an organization’s products, services, and operations comply with industry regulations and government requirements. They prepare and submit documentation for regulatory approval, monitor compliance with laws and standards, and advise teams on regulatory strategies. Their work helps companies avoid penalties, maintain certifications, and achieve smooth market entry for regulated products.
Regulatory specialists often work in industries such as healthcare, pharmaceuticals, biotechnology, food and beverage, energy, and finance. They stay updated on regulatory changes, coordinate audits, and serve as liaisons between internal departments and regulatory agencies. This role requires both technical knowledge and strong communication skills to guide teams through complex compliance requirements.
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Regulatory Specialist Core Responsibilities
- Prepare, review, and submit regulatory filings and documentation
- Ensure compliance with federal, state, and industry regulations
- Track regulatory changes and communicate updates to internal stakeholders
- Support internal and external audits or inspections
- Maintain accurate records of regulatory submissions and approvals
- Collaborate with cross-functional teams to ensure compliance in product development and operations
- Advise on labeling, marketing, and documentation to meet legal standards
- Assist with corrective actions and compliance improvement initiatives
Required Skills and Qualifications
Hard skills
- Knowledge of federal and international regulatory requirements (e.g., FDA, EMA, OSHA, SEC depending on industry)
- Proficiency in preparing regulatory submissions and documentation
- Strong research and analytical skills
- Familiarity with compliance software and documentation systems
- Understanding of audit and inspection processes
Soft skills
- Attention to detail and accuracy in documentation
- Strong written and verbal communication skills
- Ability to collaborate with cross-functional teams
- Critical thinking and problem-solving skills
- Organizational skills to manage multiple projects and deadlines
Education
- Bachelor’s degree in life sciences, regulatory affairs, business administration, law, or related field
Certifications
- Regulatory Affairs Certification (RAC) from RAPS recommended
- Industry-specific compliance certifications valued depending on field
Preferred Qualifications
- Master’s degree in regulatory affairs, public health, or related discipline
- Experience in pharmaceutical, medical device, or food safety compliance
- Background in international regulatory submissions and approvals
- Project management experience or PMP certification
- Bilingual or multilingual abilities for global regulatory coordination
National Average Salary
Regulatory specialist salaries vary by experience, industry, organization size, and geography. Click below to explore salaries by local market.
The average national salary for a Regulatory Specialist is:
$72,530
Sample Job Description Templates for Regulatory Specialists
Entry-Level Regulatory Specialist
Position Overview
We are hiring an entry-level regulatory specialist to support compliance activities and help prepare documentation for regulatory submissions. This role is perfect for recent graduates or early-career professionals looking to gain hands-on experience in regulatory affairs within a structured and supportive environment.
Responsibilities
- Assist in preparing and reviewing regulatory submissions and reports
- Maintain accurate records of compliance activities and approvals
- Research and summarize regulatory requirements and industry standards
- Support audits and inspections by organizing documentation
- Collaborate with internal teams on product labeling and documentation
- Stay current on changes to federal, state, and local regulations
Requirements
Hard skills
- Basic understanding of regulatory frameworks and compliance requirements
- Proficiency with Microsoft Office and documentation software
- Strong research and data analysis skills
- Ability to prepare accurate reports and maintain records
Soft skills
- Strong attention to detail and organizational skills
- Eagerness to learn and develop expertise in regulatory affairs
- Effective written and verbal communication
- Ability to work collaboratively in a team environment
Education
- Bachelor’s degree in life sciences, business administration, or related field
Certifications
- None required; RAC (Regulatory Affairs Certification) recommended as career develops
Preferred Qualifications
- Internship or academic project in regulatory affairs or compliance
- Bilingual or multilingual communication skills
Mid-Level Regulatory Specialist
Position Overview
Our organization is seeking a mid-level regulatory specialist to manage compliance projects and independently prepare regulatory documentation. This role requires professional experience in regulatory affairs and the ability to ensure adherence to industry standards.
Responsibilities
- Prepare, submit, and track regulatory filings for approvals
- Review product labeling, packaging, and marketing materials for compliance
- Provide guidance to internal teams on regulatory requirements
- Support regulatory inspections and assist with corrective actions
- Maintain compliance databases and reporting systems
- Monitor changes in regulatory policies and communicate impacts to leadership
Requirements
Hard skills
- Proficiency in regulatory submissions and documentation processes
- Strong knowledge of FDA, EMA, or industry-specific regulations
- Experience with compliance management software
- Ability to analyze regulatory guidance and apply to projects
Soft skills
- Strong problem-solving and critical thinking abilities
- Excellent communication and collaboration across departments
- Time management and ability to meet strict deadlines
- Detail-oriented with strong organizational skills
Education
- Bachelor’s degree required; master’s degree preferred in regulatory affairs or related field
Certifications
- RAC certification recommended
Preferred Qualifications
- 2–4 years of regulatory or compliance experience
- Experience in pharmaceuticals, medical devices, or food safety
Senior Regulatory Specialist
Position Overview
We are looking for a senior regulatory specialist to lead complex compliance initiatives, mentor junior staff, and manage high-priority regulatory submissions. This role requires advanced knowledge of regulatory affairs and a track record of successful approvals.
Responsibilities
- Lead preparation and submission of regulatory documents for major projects
- Serve as the primary point of contact with regulatory agencies
- Mentor and train junior regulatory specialists
- Develop compliance strategies to support product development and launches
- Monitor global regulatory trends and assess their impact on operations
- Lead audit and inspection readiness activities
Requirements
Hard skills
- Advanced knowledge of regulatory frameworks and global requirements
- Expertise in submission systems and compliance databases
- Strong analytical and risk assessment skills
- Ability to manage complex projects and cross-functional teams
Soft skills
- Leadership and mentoring abilities
- Strong interpersonal and communication skills
- Strategic thinking and decision-making
- Ability to influence and advise stakeholders
Education
- Bachelor’s degree required; master’s degree strongly preferred
Certifications
- RAC certification required
- Additional industry-specific compliance certifications valued
Preferred Qualifications
- 5+ years of regulatory experience in a relevant industry
- Experience managing international regulatory submissions
Lead Regulatory Specialist
Position Overview
As a lead regulatory specialist, you will oversee regulatory affairs operations, guide project teams, and ensure compliance across all business units. This role combines technical expertise with leadership responsibilities.
Responsibilities
- Supervise and coordinate activities of regulatory specialists
- Oversee preparation of submissions and ensure timely approvals
- Develop department policies and ensure adherence to regulatory requirements
- Provide expert regulatory guidance during product development
- Lead responses to regulatory inquiries and audits
- Prepare and deliver compliance reports to senior management
Requirements
Hard skills
- Comprehensive knowledge of regulatory strategy and compliance processes
- Experience managing submission timelines and team deliverables
- Proficiency in compliance reporting and audit preparation
- Ability to manage multiple projects simultaneously
Soft skills
- Leadership and supervisory abilities
- Excellent problem-solving and conflict resolution skills
- Strong written and verbal communication abilities
- Ability to work effectively with senior executives and regulators
Education
- Bachelor’s degree required; master’s degree preferred
Certifications
- RAC certification required
Preferred Qualifications
- Previous supervisory experience in regulatory affairs
- Experience with global regulatory operations
Regulatory Manager
Position Overview
We are hiring a regulatory manager to oversee department operations, manage staff performance, and ensure company-wide compliance. This leadership role requires strong managerial skills and advanced regulatory expertise.
Responsibilities
- Manage regulatory affairs staff and assign project responsibilities
- Oversee submission strategies for domestic and international approvals
- Ensure compliance with all applicable laws, regulations, and standards
- Develop departmental policies, procedures, and training programs
- Represent the organization during regulatory agency interactions
- Monitor regulatory changes and adjust business practices as needed
Requirements
Hard skills
- In-depth knowledge of regulatory compliance standards and frameworks
- Strong management and leadership skills
- Proficiency in project management and compliance software
- Ability to develop compliance strategies and programs
Soft skills
- Executive-level communication and interpersonal skills
- Strategic thinking and decision-making abilities
- Ability to manage competing priorities under pressure
- Strong mentoring and team-building skills
Education
- Bachelor’s degree required; master’s degree in regulatory affairs or business preferred
Certifications
- RAC certification required
- PMP certification recommended
Preferred Qualifications
- 7+ years of regulatory experience with at least 2 in management
- Experience managing regulatory affairs in highly regulated industries
Director of Regulatory Affairs
Position Overview
We are seeking a director of regulatory affairs to lead the company’s global regulatory strategy, oversee compliance initiatives, and manage all regulatory affairs staff. This executive-level role requires proven expertise in regulatory leadership and the ability to align regulatory operations with organizational goals.
Responsibilities
- Develop and implement global regulatory strategy across business units
- Lead and mentor regulatory affairs managers and staff
- Oversee submissions for international approvals and ensure timely compliance
- Collaborate with executive leadership on organizational strategy
- Represent the company during regulatory audits, inspections, and agency meetings
- Monitor industry trends and lead adoption of best practices
Requirements
Hard skills
- Expertise in regulatory strategy and global compliance requirements
- Strong leadership and organizational development experience
- Advanced knowledge of submission systems and regulatory frameworks
- Ability to manage multi-million-dollar budgets and complex projects
Soft skills
- Executive leadership and communication skills
- Ability to influence and collaborate at the C-suite level
- Strategic planning and vision-setting abilities
- Strong problem-solving and negotiation skills
Education
- Bachelor’s degree required; master’s degree or MBA strongly preferred
Certifications
- RAC certification required
- Additional advanced certifications valued
Preferred Qualifications
- 10+ years of regulatory experience with at least 5 in leadership roles
- Proven success in managing international compliance programs