The Senior Regulatory Affairs (RA) Specialist contributes to all regulatory functions for Moleac products such as obtaining marketing authorisations and product life-cycle management for the global market, and assigned projects.
The candidate demonstrates consistent and excellent interpersonal and communication skills along with ability to thinking critically, problem-solve and collaborate effectively with internal stakeholders.
KEY RESPONSIBILITIES
- Prepare and review registration/ variations dossiers for submission to regulatory authorities, ensuring scientific rigour, consistency and accuracy of product information, alongside good documentation practice.
- Coordinate with partners and regulatory consultants abroad to support overseas registration, in accordance to company strategy and timeline.
- Collaborate with stakeholders and contribute actively to all aspects of product life cycle management, ensuring compliance to applicable regulatory and quality requirements and continuity in commercialisation.
- Maintain and build on existing database of applicable health product regulations, standards, and guidance documents, interpreting emerging regulations and developments to assess impact on products.
- Review promotional material developed for commercial activities to ensure compliance to applicable regulatory guidelines.
- Participate in local and overseas regulatory inspections and internal audits when applicable.
- Develop and maintain effective relations with local authorities and industry associations Provide regulatory inputs and support to clinical trials and ethics committee submission.
- Assist in GDP and relevant quality assurance matters.
- Lead and support project groups to ensure business objectives are met
- Assist in formulate regulatory strategy that meets registration timeline and business objectives
- Provide guidance to the junior RA staff and interns to help build their competency
PERSONAL ATTRIBUTES/ CORE COMPETENCIES
- Highly-organised and self-disciplined.
- Resourceful, with analytical and problem-solving skills.
- Able to prioritize and work well in fast-paced environment.
- A team player with excellent interpersonal skills.
- Experienced in guiding interns or junior team member
- Driven and result focus, able to coordinate with internal and external stakeholder effect to complete task on time
- Flexible and able to pivot quickly when business objective changes
- Proficiency in English (both written and spoken). Additional language such as Mandarin is a strong plus to liaise with external CMOs and partners.
QUALIFICATIONS
- Degree in life sciences or pharmacy, with min. 3 – 5 years of relevant work experience. Prior Regulatory experience in regional setting would be advantageous
- Knowledge in international regulatory guidelines such as ICH, ASEAN, USFDA, EU etc. Regulatory experience with food supplement/ herbal medicine in Europe, North America or Asia Pacific would be advantageous.
- Good understanding in GMP, GDP and relevant quality management systems desirable.
If you believe you are a suitable candidate for this position, please send your CV and a cover letter (detailing your interest for the position, availabilities and expectations) to [email protected].
