Compliance Manager

Overview

The Compliance Manager, OTC Herbal Medicines National & International Markets will be responsible for developing, implementing, and managing the company's regulatory compliance strategy for Over The Counter (OTC) pharmaceutical products across all domestic and international markets, including e-commerce platforms. This role is critical in ensuring all products are legally marketed, safe, and adhere to global Good Manufacturing Practices (GMP) and Good Distribution Practices (GDP).

Key Responsibilities

1. Regulatory Strategy & Dossier Management

• Lead the preparation, review, submission, and maintenance of all regulatory dossiers (CTD/eCTD) for new and existing OTC products in the home country and target export markets.
• Ensure all product classifications, labelling, and promotional claims strictly adhere to the standards set by governing bodies (e.g., FDA, EMA, or local Health Authorities).
• Obtain and manage critical export documentation, including Certificates of Pharmaceutical Product (CPP) and required export licenses.
• Manage the regulatory lifecycle of products, coordinating the submission of variation dossiers for post-approval changes in manufacturing, formulation, or labelling.

2. International & Export Compliance

• Conduct regulatory intelligence and gap analyses to ensure products meet the specific requirements of target export countries (e.g., specific language requirements, stability testing, local agent registration).
• Serve as the primary liaison with foreign regulatory consultants and local agents to facilitate timely product registration and license renewal.
• Manage compliance with Import/Export Codes (IEC) and international trade regulations.
• Develop and implement processes for Pharmacovigilance (PV) and post-market surveillance in all foreign markets, ensuring the timely reporting of Adverse Drug Reactions (ADRs).

3. E-commerce & Digital Compliance

• Establish and enforce strict compliance policies for the sale of OTC products on international online platforms (e.g., Amazon, regional e-marketplaces).
• Verify that all digital marketing, product listings, images, and descriptions on e-commerce platforms align with the approved regulatory dossier and avoid unapproved health claims.
• Monitor and audit e-commerce seller compliance metrics and take corrective action against policy violations or potential product diversions.

4. Legal, Contract, & Quality Assurance

• Draft, review, and negotiate the regulatory and quality clauses within contracts and distribution agreements with international export partners.
• Ensure the contracts clearly define the export partner's responsibilities regarding GDP, quality assurance, product storage, complaint handling, and regulatory reporting in the local market.
• Conduct internal compliance audits of key functional areas (R&D, Manufacturing, Marketing, Sales) and distribution channels.
• Implement and manage a compliance hotline/reporting system and lead investigations into reported violations or misconduct, recommending and tracking corrective and preventative actions (CAPA).

Qualifications & Skills

Required

• Education: Bachelor’s degree in pharmacy, chemistry, life sciences, regulatory affairs, or a related field.
• Experience: Minimum of 5-7 years of progressive experience in Regulatory Affairs and/or Quality Compliance within the pharmaceutical or medical device industry, with direct experience handling OTC products.
• Knowledge: Deep familiarity with CTD/eCTD structure and major international regulations (e.g., FDA, EMA) and their impact on global product registration.
• Contract Management: Proven experience drafting and managing Quality Agreements and international distribution contracts.

Preferred

• Master’s degree or professional certification (e.g., RAC - Regulatory Affairs Certification).
• Experience with e-commerce compliance for regulated products.
• Fluency in a second major international business language.

Behavioural Competencies

• Integrity: Unwavering commitment to ethical standards and compliance best practices.
• Attention to Detail: Meticulous approach to documentation and regulatory filing.
• Communication: Excellent written and verbal communication skills for effective reporting to leadership and negotiation with international partners.
• Adaptability: Ability to quickly understand and translate complex and evolving international regulatory requirements into company policy.

Job Types: Full-time, Permanent

Work Location: In person