The Regulatory Affairs (RA) Specialist plays a key role in supporting all regulatory functions related to Moleac's product portfolio. This includes obtaining and maintaining marketing authorizations, managing regulatory activities throughout the product life cycle, and contributing to assigned global projects.
The ideal candidate demonstrates strong interpersonal and communication skills, critical thinking, and a collaborative mindset, with the ability to navigate complex regulatory environments.
Key Responsibilities
- Regulatory Submissions: Prepare, review, and compile high-quality regulatory dossiers for new registrations, variations, and renewals, ensuring scientific accuracy, consistency, and compliance with applicable guidelines and good documentation practices. The role will primarily support Spanish-speaking markets (e.g., LATAM), EU countries, and other assigned market.
- Global Coordination: Liaise with international partners, regulatory consultants, and local agents to support registration efforts across various markets, in alignment with corporate strategy and timelines.
- Lifecycle Management: Collaborate with internal stakeholders (e.g., Quality, Marketing, Supply Chain) to ensure compliance and timely execution of regulatory activities throughout the product life cycle.
- Regulatory Intelligence: Maintain and expand an internal database of relevant regulations, standards, and guidelines. Monitor regulatory developments and assess their impact on product compliance and marketability.
- Promotional Review: Review marketing and promotional materials to ensure compliance with applicable regulatory requirements.
- Audits and Inspections: Participate in internal audits, external regulatory inspections, and support inspection readiness activities as needed.
- Clinical & Ethics Support: Provide regulatory input and support for clinical trial applications, including submissions to Ethics Committees where required.
- Quality & Compliance Support: Assist in quality-related functions including Good Distribution Practice (GDP) activities, pharmacovigilance, and quality assurance documentation.
- Administrative Support: Contribute to other regulatory-related activities such as trademark applications, regulatory billing, and data archiving.
Personal Attributes & Core Competencies
- Highly organized, self-motivated, and detail-oriented.
- Analytical and resourceful, with strong problem-solving capabilities.
- Capable of managing multiple priorities in a fast-paced environment.
- Strong team player with excellent interpersonal and stakeholder management skills.
- Fluent in English and Spanish (spoken and written) proficiency in Mandarin or other languages is a strong advantage for liaison with regional partners and CMOs.
Qualifications & Experience
- Bachelor's degree or higher in Life Sciences, Pharmacy, or a related discipline.
- Spanish proficiency required - either a native speaker or holding a recognized business-level Spanish certification.
- 2-5 years of experience in Regulatory Affairs or related functions.
- Solid understanding of international regulatory frameworks, including ICH, ASEAN, FDA (US), EMA (EU), and other relevant regulatory authorities.
- Experience with food supplements, herbal medicines, or traditional medicines, particularly within EU regulatory frameworks, including food supplements and Traditional Herbal Medicinal Products (THMP). Familiarity with LATAM regulatory requirements would be an advantage.
- Knowledge of quality systems such as GMP, GDP, and ISO standards is desirable.
