A Regulatory Specialist in the pharmaceutical industry plays a crucial role in ensuring that pharmaceutical products comply with all relevant laws and regulations. This position requires a deep understanding of regulatory requirements at various stages of drug development, approval, and marketing. Here is an overview of the key responsibilities, qualifications, and skills typically associated with this role:
Key Responsibilities:
1. Regulatory Submissions: Prepare and submit regulatory documents, including New Drug Applications (NDAs), Biologics License Applications (BLAs), Investigational New Drug (IND) applications, and marketing authorizations to regulatory authorities like the FDA, EMA, and other global health authorities.
2. Compliance Management: Ensure that the company's pharmaceutical products comply with all local, national, and international regulations. This involves continuous monitoring of regulatory guidelines and changes.
3. Liaison with Regulatory Authorities: Act as a point of contact with regulatory bodies. This includes responding to inquiries, managing communications, and preparing for regulatory inspections.
4. Documentation and Record-Keeping: Maintain accurate and up-to-date records of all regulatory submissions, approvals, and communications with authorities.
5. Cross-Functional Collaboration: Work with various departments (R&D, clinical, manufacturing, and legal teams) to ensure that regulatory requirements are met throughout the product lifecycle.
6. Risk Assessment and Strategy: Participate in risk assessments and help develop regulatory strategies for product development and market entry.
7. Labeling and Advertising Compliance: Ensure that labeling, advertising, and promotional materials are compliant with regulatory standards.
Key Qualifications:
- Education: Typically, a bachelor's or master’s degree in life sciences, pharmacy, or a related field. A degree in regulatory affairs can be an advantage.
- Experience: 3-5 years of experience in regulatory affairs within the pharmaceutical or biotech industry.
- Regulatory Knowledge: Familiarity with regulations such as FDA, EMA, ICH, and other regional regulatory requirements. Understanding of Good Manufacturing Practice (GMP), Good Clinical Practice (GCP), and Good Laboratory Practice (GLP).
Key Skills:
- Attention to Detail: Ensuring precision in regulatory submissions and documentation.
- Project Management: Ability to manage multiple projects and deadlines simultaneously.
- Communication: Strong verbal and written communication skills for interactions with regulatory bodies and internal teams.
- Problem Solving: Ability to navigate complex regulatory issues and develop solutions that align with business objectives and regulatory requirements.
- Critical Thinking: Assessing regulatory risks and developing proactive strategies.
This position is vital for guiding pharmaceutical companies through the complex regulatory landscape and ensuring that their products reach the market efficiently while maintaining compliance with health and safety regulations.
Fortrea
Regulatory Specialist
Pune/Mumbai/Hybrid
• 7-13 years of experience in material science, formula assessment, and REACH regulations
Review the changes in the change control form
