Regulatory Pharmacist

Job Summary

The Regulatory Pharmacist cum R&D Associate is responsible for supporting product development initiatives while ensuring full regulatory compliance with FDA and other governing agencies. The role involves hands-on formulation work, scale-up participation, labeling compliance, regulatory submissions, and coordination with internal and external stakeholders to bring compliant, innovative, and market-ready products to commercialization.

Key Responsibilities

A. Product Development & R&D Functions

• Collaborate with the R&D team to develop, redesign, and improve products based on inputs from R&D Management, Sales, and Marketing.
• Execute approved formulations accurately and consistently in accordance with established procedures.
• Work independently and collaboratively to meet project milestones and team objectives.
• Participate in all stages of product scale-up, including:
• Pre-production documentation
• Sample preparation and evaluation
• Hands-on supervision of plant trials
• Shelf-life testing and evaluation
• Coordination of product data with Quality Control
• Maintain organized, complete, and up-to-date R&D documentation, records, and product samples.
• Drive new product innovation, product optimization, troubleshooting, and continuous improvement initiatives involving formulations, ingredients, and processes.
• Evaluate new raw materials, ingredients, packaging components, and processing methods through hands-on testing and validation.
• Conduct feasibility studies for new product concepts or improvements, including formulation development, moisture management, and shelf-life performance.
• Collaborate with internal and external resources such as laboratories, suppliers, packaging partners, technical services, marketing, engineering, and accounting to meet R&D objectives.
• Assist Sales and Marketing teams in presenting new product concepts, innovations, and technical features to internal and external stakeholders.
• Coordinate and consolidate all documentation supporting final product formulations and approvals.

B. Labeling & Compliance

• Ensure labeling compliance and maintain records of all FDA-approved labels.
• Review, update, and approve product label copy and designs.
• Develop accurate label content, including:
• Product name
• Net weight/measure statements
• Ingredient and allergen declarations
• Nutrition Facts Panel
• Product claims in compliance with applicable regulations and standards of identity
• Coordinate with Marketing, Packaging, and external vendors on label development and regulatory compliance.

C. Regulatory Affairs Functions

• Act as the company's official registered pharmacist representative to the FDA and other regulatory or governing agencies.
• Liaise with regulatory bodies on matters related to:
• Product registration and renewal
• Licenses and permits
• Variations and compliance filings
• IPO trademark applications
• Halal certifications and other relevant accreditations
• Evaluate the completeness, accuracy, and technical quality of regulatory documents prior to submission.
• File, track, monitor, and follow up on all regulatory applications and approvals to ensure timely compliance.
• Stay updated on new and amended laws, regulations, and guidelines issued by the FDA and other regulatory agencies.
• Ensure suppliers and manufacturers comply with documentation and record-keeping requirements in line with regulatory and company standards.
• Prepare permits and regulatory documentation required for local and international product shipments.
• Oversee quality control checks and testing for products developed and released to the market.
• Ensure all research, development, and production activities comply with food safety regulations, FDA requirements, and applicable regulatory standards.

Qualifications & Competencies

• Licensed Pharmacist (required)
• Strong knowledge of FDA regulations, food safety standards, and labeling requirements
• Experience in product development, formulation, or R&D is an advantage
• Strong attention to detail and documentation accuracy
• Ability to manage multiple regulatory and development projects simultaneously
• Effective communication and coordination skills with cross-functional teams and external agencies
• Hands-on, analytical, and solution-oriented approach
• CAN START ASAP

Job Types: Full-time, Permanent

Pay: From Php20,000.00 per month

Benefits:

• Company events
• Employee discount
• Health insurance
• Life insurance
• Paid training
• Pay raise
• Promotion to permanent employee

Work Location: In person