Summary of Job
As the head of Regulatory Affairs (RA) Department, you are responsible for managing all regulatory aspects of Moleac products currently sold in ~35 countries around the world. You will ensure that RA work is fully aligned with Moleac’s global and local scientific and commercial objectives.
You will lead the development and update of the CTD for Moleac products with input from other departments (CMC, Medical, Research). You will formulate and deploy appropriate strategy and approaches in performing all regulatory functions and addressing the requirements of Moleac products internationally including marketing authorisations, product life-cycle management, and clinical trials.
You are expected to demonstrate consistent and excellent interpersonal, communication, critical thinking, and problem solving skills along with the ability to collaborate effectively with internal and external stakeholders.
Key Responsibilities
Product registration
- Develop and provides strategic approaches for the RA team to drive registration/ variations dossiers. Ensure scientific rigour, consistency and accuracy of product information, alongside good documentation practices to drive a smooth flow in the processes with regulatory authorities.
- Oversee and manage strategic communication with stakeholders such as regulatory authorities, consultants and partners for product life cycle management to ensure compliance to applicable regulatory and quality requirements and continuity in commercialisation in a timely manner.
- Develop and maintain a robust database of applicable health product regulations, standards, and guidance documents, interpreting emerging regulations and developments to assess their impact on products.
- Plan and provide guidance in the conduct of internal audits to ensure compliance to GDP standards.
- Provide guidance and internal regulatory audit to promotional materials developed for commercial activities to ensure compliance with applicable regulatory guidelines.
- Develop and maintain effective relations with local authorities and industry associations.
- Oversee trademark portfolio.
Quality Assurance
- Work closely with Head, Quality Assurance (QA), in the assessment of product complaints and addressing quality-related issues through the implementation of effective corrective and preventive actions.
Clinical trials
- Provide regulatory strategic approaches and guidance in clinical trials and ethics committee submissions.
Team development
Lead the RA team to remain at peak performance. Mentor and guide each team member to ensure they have all the competencies needed to perform their role effectively and experience continued professional growth.
Personal Attributes/ Core Competencies
1. Proactively drive for results.
2. Resourceful and analytical, Highly-organized and self-disciplined.
3. Determined, Resilient, able to thrive in challenging environment, and maintain focus when faced with challenges.
4. Leadership qualities that inspire, motivate, focus on achieving company goals, and foster a collaborative and high performing culture.
5. Excellent in English language (both written and spoken). Ability to speak other languages such as Mandarin is a strong plus, helpful in liaising with external CMOs and partners.
Qualifications
1. A Pharmacist Degree or a Degree in life sciences, with minimum of 8 years of relevant work experience in pharmaceutical industry Global Regulatory Affairs.
2. Knowledge in international regulatory guidelines such as ICH, ASEAN, USFDA, EU etc. Experience in pharmaceuticals / herbal medicine / food supplement in Europe, North America and Asia Pacific would be advantageous.
3. Expert knowledge in GxP and relevant quality management systems desirable.
