Regulatory Affairs Manager

The Regulatory Affairs Manager is to lead and manage regulatory affairs activities for Singapore and assigned ASEAN markets, ensuring compliance with all relevant laws, regulations, and standards.

The incumbent is responsible for developing and executing regulatory strategies, overseeing the preparation and submission of regulatory dossiers, and facilitating successful product registrations, particularly for biologics and oncology products. The manager will act as the primary liaison with regulatory authorities, collaborate closely with internal and external stakeholders, and provide expert guidance on evolving regulatory requirements to support business objectives.

JOB DESCRIPTION

- Develop and execute regulatory strategies and plans to ensure compliance with applicable laws, regulations, and standards.

- Lead preparation and submission of regulatory dossiers, including NDAs/MVAs/BLAs/sBLAs, CTAs, CMC variations, per biologics and oncology-specific requirements.

- Review dossier provided to support CMC variations from Singapore and assigned ASEAN markets regulatory perspective and identify gaps and risks.

- Support Lifecycle Management: label updates, safety variations, renewals, and post-marketing commitments across Singapore and assigned ASEAN markets.

- Evaluate proposed post-approval changes for impact assessments in Singapore and assigned ASEAN markets and provide regulatory strategies that support change implementation.

- Support in Marketing Authorization related activities for the assigned projects.

- Liaise with HSA and act as the primary point of contact during regulatory agency interactions, inspections and audits.

- Closely collaborating with the regulatory teams of the Distributors and internal regulatory teams for assigned projects and general matters.

- Collaborate with Medical Affairs, Safety, Market Access, Quality, and Commercial teams to align strategies and accelerate approvals.

- Provide regulatory guidance and support to internal stakeholders, provide expert guidance on Singapore and ASEAN regulations, oncology-specific guidelines, and evolving biologics/advanced therapy requirements.

- Assess scientific data packages for registration purposes against local regulatory/clinical requirements, identifying gaps and developing mitigation strategies to address gaps.

- Lead and contribute to the compilation of high-quality documentation for submissions and correspondences with regulatory authority, maintain archives and tracking systems to ensure easy and quick access to all documents and transparency on status of regulatory activities.

- Review promotional materials to validate prescribing information, product labels and indications as necessary.

- Keep abreast with industry updates, provide regulatory intelligence, risk assessments, and insights to senior leadership.

JOB REQUIREMENTS

- Bachelor's or Master's degree in Pharmacy or related discipline.

- Minimum 5 to 8+ years of regulatory experience, at least 4 years of local experience.

- Registered Pharmacist with the Singapore Pharmacy Council (SPC) is required.

- Significant experience in Oncology product submissions, familiar with regulatory reliance and collaborative pathways.

- In-depth knowledge of the regulatory requirements of countries within the ASEAN region with submission experience, procedural requirements and data transparency.

- Proven track record in leading regulatory submissions and managing authority interactions across the region.

- Strong in analytical abilities and stakeholder engagement skills.

- Excellent interpersonal, written and verbal communication skills.

- Ability to multitask, manage complexity, multiple and changing priorities and tight timelines with high accountability.

- Prior experience in regional or global regulatory coordination experience.

- Demonstrated experience in managing regulatory strategy and submission of dossiers including data review, approval strategies and labelling negotiations, interacting with HSA and local health experts, submission of biologics - NDAs/ BLAs and experience working with distributors.

- Ability to work in cross-functional working environment, with colleagues from different region and time zone.

- Experience in CMC lifecycle management.