Regulatory Scientist
A Regulatory Scientist ensures products meet regulatory standards. They compile and analyze scientific data, handle regulatory submissions, and communicate with regulatory agencies for approvals in sectors like pharmaceuticals, biotechnology, and food.
Top Articles for Regulatory Scientist
Sample Job Descriptions for Regulatory Scientist
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
We are currently seeking a detail-oriented and analytical Junior Regulatory Scientist to help ensure our company's products comply with regulatory standards. The ideal candidate will support the development and registration of products, perform regulatory research, and assist with the preparation and submission of documentation to regulatory agencies.
Required Skills
- Knowledge of regulatory submission processes.
- Familiarity with regulatory databases and tools.
- Proficiency in Microsoft Office Suite.
- Basic understanding of Good Manufacturing Practices (GMP), Good Clinical Practices (GCP), and Good Laboratory Practices (GLP).
- Adaptability to a fast-paced and changing environment.
Qualifications
- Bachelor's degree in a scientific discipline such as biology, chemistry, pharmacology, or related field.
- Understanding of regulatory framework and guidelines (e.g., FDA, EMA, ICH).
- Strong analytical and problem-solving skills.
- Effective communication and writing skills.
- Ability to work collaboratively in team settings.
Responsibilities
- Assist in developing regulatory strategies for new and existing products.
- Participate in the preparation and submission of regulatory filings.
- Conduct thorough research on regulatory requirements and updates.
- Collaborate with cross-functional teams to gather necessary documentation and data.
- Review and maintain records of communication with regulatory agencies.
- Support compliance audits and inspections.
- Help in the preparation of responses to regulatory agencies' questions and requests.
Intermediate (2-5 years of experience)
Summary of the Role
The Regulatory Scientist will be responsible for supporting the development of regulatory strategies and interacting with regulatory agencies. They will participate in preparing regulatory submissions and ensure compliance with regulatory requirements in the healthcare or related industry.
Required Skills
- Strong analytical and problem-solving skills.
- Excellent written and verbal communication skills.
- Ability to work in a fast-paced and dynamic environment.
- Strong attention to detail and organizational skills.
- Ability to manage multiple projects with tight deadlines.
- Proficiency with regulatory submission software and Microsoft Office Suite.
Qualifications
- Bachelor’s degree in life sciences, pharmacy, or a related field.
- 2-5 years of experience in regulatory affairs within the pharmaceutical, biotechnology or related industry.
- Direct experience with regulatory submissions and interactions with health authorities.
- Understanding of global regulatory guidelines and their application to drug development.
- Familiarity with electronic submission processes and regulatory databases.
Responsibilities
- Develop and implement regulatory strategies for new and existing products.
- Prepare, compile, and submit regulatory filings, such as INDs, NDAs, BLAs, and MAAs, ensuring timely and accurate submissions.
- Interact with regulatory agencies to facilitate the review and approval process of regulatory submissions.
- Evaluate regulatory risks of product candidates and propose risk mitigation strategies.
- Collaborate with cross-functional teams to ensure alignment of regulatory strategies with corporate goals.
- Review and interpret regulatory guidelines and provide guidance to project teams.
- Maintain current knowledge of relevant regulations, including FDA, EMA, and other international regulatory agencies.
- Contribute to the development of best practices for Regulatory Affairs processes.
Senior (5+ years of experience)
Summary of the Role
As a Senior Regulatory Scientist, you will be an expert in regulatory affairs, specializing in the development of regulatory strategies and submissions for pharmaceutical, biotechnology, and medical device products. You will collaborate with cross-functional teams to ensure compliance with local and international regulations and manage regulatory submissions throughout the product lifecycle.
Required Skills
- Excellent written and verbal communication skills.
- Strong organizational and project management abilities.
- Keen attention to detail and the ability to manage multiple projects concurrently.
- Diplomatic negotiation and influencing skills.
- Solid problem-solving and analytical thinking skills.
- Proficient in the use of electronic submission software and regulatory information management systems.
- Adaptability to change and resilience in challenging environments.
- Ability to mentor and guide less experienced team members.
Qualifications
- Bachelor's degree in a life sciences discipline; advanced degree (PhD, PharmD, MD) preferred.
- A minimum of 5 years of experience in regulatory affairs within the pharmaceutical, biotech, or medical device industry.
- Proven track record of successful regulatory submissions.
- Deep understanding of FDA, EMA, and ICH guidelines, as well as other international regulatory requirements.
- Experience with electronic submission processes and regulatory databases.
- Prior interaction with regulatory authorities and a strong understanding of the regulatory landscape.
- Ability to analyze and interpret complex scientific data.
- Experience in project management and leadership within a regulatory affairs setting.
Responsibilities
- Develop and implement regulatory strategies for new and existing products.
- Prepare, coordinate, and review regulatory submissions, including INDs, NDAs, BLAs, and MAAs.
- Lead cross-functional teams to gather necessary documentation for regulatory submissions.
- Stay current with regulatory guidelines and legislation, advising on any changes that may impact the company's products or processes.
- Interact with regulatory agencies, including preparing for meetings and managing correspondence.
- Guide and mentor junior regulatory affairs personnel.
- Monitor the progress of regulatory submissions and respond to requests for additional information.
- Provide regulatory expertise on clinical, nonclinical, and CMC aspects to ensure all data meets regulatory standards.
- Ensure compliance with post-approval regulatory requirements.
- Participate in due diligence activities for in-licensing and acquisitions.
See other roles in Science and Technology and Pharmaceutical