Scientific and Regulatory Affairs Manager Calauan Laguna-based
Calauan, Laguna
Posted 19 days ago
- Company:
- Dempsey Resource Management Inc.
- Company Description:
- Dempsey Resource Management Inc. (DEMPSEY) is an executive search and referral services company. We do assist our client companies in the sourcing of competent and qualified candidates to fill up various job positions in their organization. The job positions we are targeting for our referred candidates are those intended for direct hiring by our clients. Our company is not a contracting agency. We do not hire and deploy people to other companies for contractual, temporary jobs or even special projects.
- Contract Type:
- Full Time
- Experience Required:
- 5 to 10 years
- Education Level:
- Bachelor’s Degree
- Number of vacancies:
- 1
Job Description
Responsibilities:
Develop and implement regulatory strategies to ensure product and process compliance with applicable laws, regulations, and standards (e.g., FDA, ISO, regional).
Prepare and submit regulatory submissions (registrations, pre-market notifications, post-market reports).
Liaise with regulatory authorities, acting as the primary contact during inspections, audits, and interactions.
Conduct risk assessments and develop mitigation strategies for regulatory risks.
Provide regulatory guidance to internal stakeholders (R&D, Quality Assurance, Legal) throughout the product lifecycle.
Qualifications:
Bachelor's degree in a scientific discipline, engineering, or a related field; Master's degree preferred.
10+ years of relevant experience as a Scientific and Regulatory Affairs Manager in food manufacturing.
In-depth knowledge of relevant regulations and standards (FDA, ISO, regional).
Strong understanding of quality systems and their application to regulatory requirements.
Proven track record of successfully developing and executing regulatory strategies and obtaining product approvals.
