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Title
Text copied to clipboard!Regulatory Affairs Specialist
Description
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We are looking for a Regulatory Affairs Specialist to join our team and ensure that our products meet all regulatory requirements and standards. This role is critical in navigating the complex landscape of local, national, and international regulations that govern the development, approval, and marketing of products, particularly in the healthcare, pharmaceutical, and biotechnology industries.
As a Regulatory Affairs Specialist, you will be responsible for preparing and submitting regulatory documents to regulatory agencies, maintaining compliance with applicable laws and regulations, and working closely with cross-functional teams including R&D, quality assurance, and manufacturing. You will also monitor changes in regulatory legislation and guidelines and assess their impact on the company’s operations and product portfolio.
The ideal candidate will have a strong understanding of regulatory frameworks such as FDA, EMA, and ICH guidelines, excellent communication skills, and the ability to manage multiple projects simultaneously. Attention to detail, analytical thinking, and a proactive approach to problem-solving are essential for success in this role.
This position offers the opportunity to work in a dynamic and fast-paced environment where your contributions directly impact the success and safety of our products in the market. If you are passionate about regulatory compliance and want to play a key role in bringing innovative products to market, we encourage you to apply.
Responsibilities
Text copied to clipboard!- Prepare and submit regulatory documents to relevant authorities
- Ensure compliance with local, national, and international regulations
- Monitor and interpret regulatory requirements and changes
- Collaborate with cross-functional teams to support product development
- Maintain regulatory files and documentation
- Participate in audits and inspections
- Provide regulatory guidance during product lifecycle
- Review product labeling and promotional materials for compliance
- Support registration and licensing activities
- Communicate with regulatory agencies as needed
Requirements
Text copied to clipboard!- Bachelor’s degree in life sciences, pharmacy, or related field
- 2+ years of experience in regulatory affairs or related role
- Knowledge of FDA, EMA, and ICH guidelines
- Strong written and verbal communication skills
- Attention to detail and organizational skills
- Ability to manage multiple projects and deadlines
- Proficiency in Microsoft Office and regulatory databases
- Experience with regulatory submissions and documentation
- Understanding of product development processes
- Ability to work independently and in a team environment
Potential interview questions
Text copied to clipboard!- Do you have experience with FDA or EMA regulatory submissions?
- Can you describe a time you managed multiple regulatory projects?
- How do you stay updated on changes in regulatory guidelines?
- What is your experience with product labeling compliance?
- Have you participated in regulatory audits or inspections?
- What regulatory databases or tools are you familiar with?
- How do you ensure accuracy in regulatory documentation?
- What is your approach to cross-functional collaboration?
- Can you explain your understanding of ICH guidelines?
- What challenges have you faced in regulatory affairs and how did you overcome them?
