Regulatory Associate

Job Title: Regulatory Associate

Department: Regulatory

Work Set Up: Onsite

Reports To: CSO

JOB SUMMARY

The Regulatory Associate is responsible for ensuring that all company products and operations comply with national regulatory standards, particularly FDA requirements for Cosmetics and Food. This role supports regulatory documentation, product registration, compliance monitoring, and coordination with internal teams and external agencies. The Regulatory Associate will play a critical role in maintaining product safety, regulatory integrity, and timely market access.

KEY RESPONSIBILITIES

Regulatory Compliance

• Ensure compliance with FDA regulations for cosmetics, food, and other relevant product categories.
• Monitor, interpret, and implement changes in regulatory guidelines that may impact product development or marketability.
• Maintain alignment with industry standards for product registration, manufacturing, and labeling compliance.

Documentation & Submissions

• Prepare, compile, and submit regulatory documents such as FDA applications, CPR, GMP related submissions, and product notifications.
• Maintain updated, accurate, and organized records of all regulatory files, correspondences, and submission histories.
• Track all regulatory timelines to ensure timely approvals.

Cross-Functional Support

• Work closely with R&D, QA, QC, and Marketing to ensure compliance during formulation, testing, packaging, and commercialization.
• Review product labels, claims, artwork, promotional materials, and batch records for regulatory accuracy and compliance.

Regulatory Liaison

• Serve as point of contact with regulatory agencies to address questions, deficiencies, or required clarifications.
• Support preparation and coordination during FDA regulatory inspections and internal audits.
• Assist in responding to regulatory concerns and providing necessary documentation.

Continuous Improvement

• Stay updated on emerging regulatory trends, local and international guidelines, and best practices.
• Provide internal training to relevant teams regarding new regulations and compliance requirements.

ADDITIONAL RESPONSIBILITIES

• Assist in product classification, ingredient compliance review, and risk assessment prior to launch.
• Support regulatory database maintenance and documentation tracking systems.
• Participate in internal quality system initiatives and SOP improvements.
• Assist in drafting Standard Operating Procedures related to regulatory workflows.
• Provide support during emergency regulatory updates (e.g., product holds, reformulations, immediate label changes).

QUALIFICATION AND REQUIREMENTS

EDUCATION

• Bachelors degree in Pharmacy, Chemistry, Biology, Life Sciences, or any related scientific field.

EXPERIENCE

• 0 to 3 years experience in Regulatory Affairs, preferably in chemical manufacturing, cosmetics, pharmaceuticals, biotechnology, or medical devices.
• Fresh graduates with strong scientific and documentation background may be considered.

SKILLS

• Strong understanding of FDA guidelines, ASEAN Cosmetic Directive, Food regulations, and international standards.
• Excellent organizational skills and high attention to detail.
• Strong analytical thinking and problem-solving ability.
• Proficiency in MS Office (Word, Excel, PowerPoint) and familiarity with regulatory submission tools (e.g., eCTD).
• Strong verbal and written communication skills.

GROWTH AND DEVELOPMENT OPPORTUNITIES

• Exposure to multi-category regulatory compliance (Cosmetics, Food, Supplements).
• Opportunity to become a Regulatory Specialist or Regulatory Supervisor.
• Training in advanced regulatory sciences, dossier preparation, GMP, and quality systems.
• Involvement in cross-functional projects with R&D, QA, QC, and Marketing.
• Participation in company-sponsored regulatory certifications and seminars.

WORK ENVIRONMENT

• Office-based with routine coordination across R&D, QC, Production, and QA departments.
• Collaborative environment requiring close interaction with internal teams and regulatory authorities.
• Fast-paced setting with strict documentation and submission timelines.
• May require occasional visits to manufacturing facilities or regulatory offices (e.g., FDA).

EQUAL OPPORTUNITY STATEMENT

• Dermorepubliq is an equal opportunity employer and is committed to fostering a diverse and inclusive work environment

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