Regional Regulatory Affairs Manager

SciGen is looking for a Regional Regulatory Affairs Manager to support the Global Regulatory Affairs team in our Singapore headquarters. The incumbent is responsible for product assessment on registration potential, while executing both strategic and operational product lifecycle activities from due diligence and regulatory intelligence, timely preparations and submissions, to maintenance and post-market compliance. This position reports to the Head of Regulatory Affairs.

Responsibilities

• Prepare, compile, evaluate and review registration dossiers, applications and post-approval activities in a timely manner.
• Support due diligence projects and regulatory intelligence for specific product(s).
• Partner the Business Development team in assessment of registration potential for new portfolio(s) and / or product(s) expansion, including commercial viability as needed.
• Gain and maintain knowledge of relevant internal procedures and appropriate external guidance documents i.e. ICH, FDA, EMA, WHO and applicable local and regional guidelines.
• Interpret and communicate the impact and relevance of regulations to relevant stakeholders and queries from various regulatory and governing authorities.
• Coordinate and participate in preparations for Regulatory Authority meetings including the development of regulatory strategy, questions, background documentation etc. as required to ensure that the objectives of the meeting are achieved.
• Identify and share new updates and changes, and escalate potential compliance and business risks in a timely manner to implement appropriate mitigation plans or corrective measures in consultation and agreement with Management if any activities, strategies or policies are not aligned with internal or external requirements.
• Anticipate future problems and probable solutions and way forward, resolve current issues that improve functional works with relevant stakeholders.
• Ensure all project-related regulatory activities are completed in a timely manner and in compliance to the overall regulatory strategy and goals.
• Provide coaching and guidance to local Regulatory Affairs colleagues to ensure Company is well represented to regulatory authorities.
• Ensure regulatory meeting minutes are recorded, and additional undertakings, activities or commitments resulting from the meetings are expeditiously completed.
• Ensure core documents, electronic and paper regulatory archives are organised and maintained or archived in accordance with internal procedures.
• Ensure ongoing professional development and training course(s) meet the Company’s current and developing regulatory needs and professional licence maintenance.
• Support in both internal and external audits as required.

Requirements

• Degree in Pharmacy, Pharmacology, Pharmaceutical Sciences, Biology, Chemistry, or related field(s).
• At least five (5) years in Asia Pacific regional pharmaceutical regulatory experience; Middle East plus Africa and / or Latin America regions are preferred.
• Strong knowledge of new submissions, Marketing Authorisation Holder (“MAH”) maintenance and variation submissions.
• Good track record of submissions and approval deliverables.
• Experience in medical devices registrations and submissions are an added advantage.
• Proficient in Common Technical Dossier (“CTD”) and / or ASEAN CTD requirements.
• Good written and verbal English language skills.
• Independent and proactive with business acumen.
• Demonstrates critical thinking and problem-solving mindset.
• Collaborate well with cross-functional teams in a fast paced environment.
• Licence as a Registered Pharmacist is highly preferred.