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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
Responsibilities:
- 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.
- Provide regulatory guidance and support to internal stakeholders, including product development teams, senior management, and external partners.
Qualifications:
- Bachelor's degree in Regulatory Affairs, Life Sciences, Pharmacy, Chemistry, or related field required; advanced degree preferred.
- 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.
- Regulatory affairs certification (RAC) is a plus.
The Regiatory Affairs Officer opportunity is used to fill high-volume roles or frequently hired positions to be used for future openings. By filling out an application you are joining our LiveMarket, where you have the opportunity to be matched with openings that are the right fit for you. The responsibilities and requirements of each role vary by opportunity. Our team will help guide you on how to best showcase your skills and match you to the right opportunity for you!