What are the responsibilities and job description for the Regulatory Affairs Officer position at Katalyst Healthcares & Life Sciences?
Responsibilities:
- The Regulatory Affairs Officer will play a key role in ensuring compliance with regulatory requirements and standards governing the development, manufacturing, and distribution of products.
- Research, interpret, and stay up to date with regulatory requirements and standards relevant to industry and products.
- Assist in the preparation, review, and submission of regulatory filings, applications, and documentation to regulatory authorities, including FDA, EMA, and other regulatory agencies,
- Coordinate and track regulatory submissions and approvals, ensuring compliance with timelines and requirements.
- Liaise with regulatory authorities and respond to inquiries, requests for information, and regulatory notifications in a timely manner.
- Assist in the development and implementation of regulatory strategies and plans for new product development, registration, and commercialization.
- Collaborate with cross-functional teams, including R&D, Quality Assurance, Manufacturing, and Marketing, to ensure regulatory compliance throughout the product lifecycle.
- Maintain regulatory documentation and records in accordance with regulatory requirements and internal procedures.
- Strong knowledge of regulatory requirements and standards, including FDA regulations, EU directives, ICH guidelines, and other international regulations.
- Excellent analytical and problem-solving skills, with the ability to interpret and apply complex regulatory guidelines and requirements.
- Excellent communication and interpersonal skills, with the ability to effectively communicate with internal and external stakeholders at all levels.
- Detail-oriented with a high level of accuracy and attention to detail.
- Ability to work independently and collaboratively in a fast-paced environment.
- Proficiency in Microsoft Office Suite and other office productivity tools.
