Regulatory Affairs Specialist
7 days ago
PureTek is a dynamic and innovative company specializing in developing and manufacturing pharmaceutical and cosmetic products. With a commitment to quality, safety, and regulatory compliance, we strive to deliver products that enhance the well-being and beauty of our consumers. Join our team and contribute to our mission of creating high-quality healthcare and beauty solutions.
Job Description:
We are currently seeking a highly motivated and detail-oriented Regulatory Affairs Specialist to join our team. As a Regulatory Affairs Specialist, you will be pivotal in ensuring compliance with regulatory requirements for our pharmaceutical and cosmetic products. Your responsibilities will include preparing and submitting regulatory documents, coordinating with regulatory authorities, and keeping abreast of evolving regulations to support our product development and commercialization efforts.
Responsibilities:
- Collaborate with cross-functional teams to ensure regulatory compliance throughout the product lifecycle, from development to commercialization.
- Prepare and submit regulatory documents, such as product registration dossiers, technical files, and labeling requirements, to regulatory authorities in compliance with applicable regulations.
- Support the compilation and maintenance of product regulatory files, ensuring the accuracy and completeness of all required documentation.
- Conduct regulatory assessments of product formulas, packaging, and labeling to ensure compliance with local and international regulations.
- Stay updated on changes in regulatory requirements for pharmaceutical and cosmetic products, communicate these changes to internal stakeholders, and develop strategies for compliance.
- Assist in the coordination and preparation of regulatory submissions and product variations, as applicable.
- Interact and communicate effectively with regulatory authorities to address inquiries, respond to queries, and provide necessary information to support product registrations and approvals.
- Collaborate with quality assurance and R&D teams to ensure compliance with applicable Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and other relevant quality standards.
- Participate in regulatory audits and inspections, providing necessary documentation and support to regulatory authorities.
Qualifications:
- Bachelor's degree in a scientific discipline or a related field (advanced degree preferred).
- Minimum of 3 years of experience in regulatory affairs within the pharmaceutical and/or cosmetic industry.
- Strong understanding of local and international regulatory requirements for pharmaceutical and/or cosmetic products.
- Experience with the preparation and submission of regulatory documents, such as product registration dossiers and technical files.
- Familiarity with regulatory guidelines, including the FDA, and other relevant authorities.
- Detail-oriented mindset with excellent analytical and problem-solving skills.
- Effective communication and interpersonal skills to collaborate with internal teams and regulatory authorities.
- Ability to work independently, prioritize tasks, and manage multiple projects simultaneously.
- Proficiency in relevant software applications and databases used in regulatory affairs.
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