Regulatory Affairs Specialist
This job involves ensuring that an organization complies with all of the regulations and laws pertaining to its business. They work with federal, state, and local regulatory agencies and personnel on specific issues affecting their business.
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Sample Job Descriptions for Regulatory Affairs Specialist
Below are the some sample job descriptions for the different experience levels, where you can find the summary of the role, required skills, qualifications, and responsibilities.
Junior (0-2 years of experience)
Summary of the Role
The Regulatory Affairs Specialist will assist with the preparation and submission of regulatory documents and maintain compliance with regulatory requirements for products in the pharmaceutical, biotechnology, or medical device industries. This role is entry-level, focusing on gaining industry knowledge and supporting regulatory processes.
Required Skills
- Detail-oriented with the ability to manage multiple tasks and meet deadlines.
- Strong organizational skills and the ability to maintain detailed records.
- Analytical thinking and problem-solving skills.
- Basic understanding of the drug development process and regulatory submissions.
- Ability to quickly learn and apply new information and technologies.
Qualifications
- Bachelor's degree in a related field such as Life Sciences, Pharmacy, or Regulatory Affairs.
- Familiarity with regulatory requirements and guidelines (FDA, EMA, etc.).
- Strong written and verbal communication skills.
- Ability to work in a team environment and collaborate with others.
- Proficient in Microsoft Office applications, especially Word, Excel, and PowerPoint.
Responsibilities
- Assist in the preparation and submission of regulatory documents to government agencies.
- Maintain and organize regulatory documentation and filings.
- Coordinate with cross-functional teams to gather relevant information for regulatory submissions.
- Participate in regulatory strategy meetings and provide administrative support.
- Assist in the tracking and reporting of regulatory timelines and milestones.
- Perform initial review of labels, promotional material, and other communications for compliance with regulations.
- Support the regulatory team in maintaining compliance with all applicable laws and regulations.
- Keep up to date with changes in regulatory legislation and guidelines.
Intermediate (2-5 years of experience)
Summary of the Role
The Regulatory Affairs Specialist will be responsible for ensuring that products meet all of the legislative requirements mandated by health authorities. The role involves interacting with regulatory agencies, preparing submission documents, and maintaining compliance with all regulations throughout the product lifecycle.
Required Skills
- Strong analytical and critical thinking skills.
- Excellent written and verbal communication skills.
- Ability to work well under pressure and meet deadlines.
- Detail-oriented with an aptitude for precision.
- Proficient in MS Office and regulatory affairs software.
Qualifications
- Bachelor's degree in life sciences, biology, chemistry, medical sciences or related field.
- 2-5 years of experience in regulatory affairs within the pharmaceutical, biotechnology, or medical device industry.
- Experience with regulatory submissions, including INDs, NDAs, BLAs, ANDAs, or 510(k)s.
- Knowledge of FDA, EMA, and other regulatory agency requirements and guidance.
- Familiarity with Good Manufacturing Practice (GMP), Good Clinical Practice (GCP), and Good Laboratory Practice (GLP) regulations.
Responsibilities
- Prepare and submit regulatory submissions to obtain approvals for new products and product changes as required.
- Coordinate and compile materials for license renewals, updates and registrations.
- Maintain current knowledge of relevant regulations, including proposed and final rules.
- Interact with regulatory agencies as part of the submission and approval process.
- Assist in the development of regulatory strategies and provide regulatory guidance to teams within the company.
- Monitor impact of changing regulations on submission strategies and update internal stakeholders.
- Ensure compliance with product post-marketing approval requirements.
- Review product labeling and marketing materials for compliance with regulatory requirements.
- Assess product changes for significance to regulatory submissions and make appropriate filings.
- Provide regulatory input to product recall strategies.
Senior (5+ years of experience)
Summary of the Role
As a Senior Regulatory Affairs Specialist, you will play a crucial role in ensuring our company's products meet all regulatory standards and comply with industry and government regulations. You will be responsible for managing regulatory submissions, maintaining knowledge of current regulations, and acting as a liaison between our company and regulatory authorities.
Required Skills
- Strong analytical and problem-solving skills.
- Exceptional written and verbal communication skills.
- Detail-oriented with strong organizational skills.
- Ability to work in a fast-paced, deadline-driven environment.
- Advanced proficiency with document management and regulatory information systems.
- Proven ability to build and maintain professional relationships with regulatory authorities.
- Leadership and team management skills.
- Ability to mentor and support junior staff.
Qualifications
- Bachelor's or Master's degree in life sciences, pharmacy, or a related field.
- Minimum of 5 years of experience in regulatory affairs within the pharmaceutical, biotechnology, or medical device industry.
- Proven track record of successful submissions and interactions with regulatory agencies.
- Strong understanding of regulatory requirements and processes in key markets (e.g., FDA, EMA, PMDA).
- Experience with international regulatory submissions and regulations.
- Familiarity with GxP regulations (GMP, GLP, GCP) and ISO standards.
- Ability to interpret and communicate regulatory guidelines and scientific data.
- Excellent project management skills with the ability to lead and manage multiple projects simultaneously.
Responsibilities
- Develop and implement regulatory strategies for product submissions.
- Prepare and submit regulatory documents to agencies, ensuring compliance with all applicable requirements.
- Coordinate with cross-functional teams to collect necessary data and information for regulatory submissions.
- Stay current with regulatory updates and changes within the industry, and inform relevant departments.
- Lead and manage regulatory projects, ensuring timelines and deliverables are met.
- Provide regulatory guidance to teams on issues such as labeling, marketing material, and product changes.
- Review product labeling, promotional material, and changes to ensure regulatory compliance.
- Participate in audits and inspections by regulatory authorities and implement corrective actions as necessary.
- Serve as the primary contact with regulatory authorities, managing communications and negotiations.
- Mentor and provide guidance to junior regulatory staff.
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