Regulatory Affairs Team Leader
2 weeks ago
As a Regulatory Affairs Team Leader, you will play a pivotal role in guiding and developing a team of Regulatory Affairs Associates. Your expertise will be essential in navigating complex regulatory landscapes and ensuring compliance across various domains.
Key Responsibilities
1. **Team Leadership**: Mentor and supervise a dedicated team, providing insights on regulatory issues and overseeing their daily activities.
2. **Audit Management**: Coordinate cGMP, Environmental, and Regulatory audits, liaising with both internal teams and external regulatory bodies.
3. **Documentation Oversight**: Ensure the creation and upkeep of essential product master files (dossiers) and drug master files (DMF), working closely with the Research & Development department.
4. **Regulatory Document Review**: Supervise the generation and evaluation of critical regulatory documents, including Certificates of Compliance (CoCs), Certificates of Analysis (CoAs), and safety data sheets for both local and international submissions.
5. **Compliance Strategy Development**: Formulate and execute strategies to align with global regulatory standards, including those set by FDA, EPA, OSHA, ISO 13485:2003, and COSMOS/ECOCERT.
6. **Registration Management**: Oversee facility registrations, renewals, and submissions to regulatory agencies, ensuring precision and timeliness.
7. **Audit Investigation Leadership**: Lead inquiries related to audit outcomes and manage responses to regulatory audits.
8. **Quality Review and Training**: Conduct regular quality assessments, regulatory updates, and annual training sessions for the regulatory affairs team and relevant departments.
9. **Product Compliance Assessment**: Supervise the compliance evaluation process for new formulations and product launches, ensuring they meet regulatory criteria.
10. **SOP Development**: Create and maintain Standard Operating Procedures (SOPs), specification controls, and change control programs pertinent to regulatory affairs.
11. **Regulatory Landscape Monitoring**: Stay informed about evolving global regulatory requirements and implement necessary adjustments to maintain compliance.
12. **Cross-Functional Collaboration**: Work alongside various teams to ensure regulatory considerations are integrated into product development, manufacturing, and marketing initiatives.
13. **Report Management**: Oversee the generation and maintenance of reports related to Cosmos Natural, Cosmos Organic, and NOP for ingredients and products.
14. **Regulatory Guidance for New Products**: Provide expert regulatory advice and support for new product development projects.
15. **Representation**: Act as the representative for the Regulatory Affairs department in management meetings and external regulatory discussions.
Qualifications
- Bachelor's degree in Life Sciences, Engineering, or a related field; Master's degree preferred.
- A minimum of 5 years of experience in regulatory affairs within the drug, cosmetic, or medical device sectors.
- Comprehensive knowledge of FDA regulations under 21CFR 210, 211, & 820.
- Proven track record in managing regulatory processes, audits, and compliance activities.
- Strong understanding of global regulatory frameworks and requirements.
- Experience in leading and mentoring teams.
- Proficiency in data analysis and regulatory information management systems.
- Familiarity with quality management systems (QMS) and ISO standards.
Benefits
- Medical, Dental, and Vision Insurance
- Life Insurance
- 401k match
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