Regulatory Affairs

Key Responsibilities:

- Prepare, review, and submit regulatory documentation to ensure compliance with local, regional, and international regulations.
- Collaborate with cross-functional teams including R&D, Quality Assurance, and Marketing to facilitate the timely delivery of products to the market.
- Monitor changes in regulatory policies and ensure that all activities remain compliant with applicable laws and regulations.
- Provide guidance on regulatory requirements for product development and marketing strategies.
- Conduct regulatory assessments of new products and changes to existing products, ensuring all documentation meets regulatory standards.
- Maintain up-to-date knowledge of industry trends, best practices, and emerging regulations that impact the business.
- Assist in the training and education of staff on regulatory compliance issues.

Qualifications:

- Bachelor’s degree in Life Sciences, Pharmacy, Regulatory Affairs, or a related field. Advanced degrees are a plus.
- Minimum of 2-5 years of experience in regulatory affairs, preferably within the pharmaceutical, biotechnology, or medical device sectors.
- Strong understanding of regulatory requirements and standards (e.g., FDA, EMA, ISO).
- Excellent analytical, problem-solving, and organizational skills.
- Exceptional written and verbal communication skills, with the ability to communicate complex information clearly and effectively.
- Proficient in regulatory submission tools and software.
- Detail-oriented with a proactive approach to identifying and addressing potential compliance issues.