RA Manager

HRnetGroup Singapore; Singapore; On-site; SGD 60,000 - 80,000; Full time

Job summary

A prominent recruitment firm in Singapore is seeking an experienced Regulatory Affairs professional to lead the preparation and submission of high-quality regulatory dossiers to health authorities. The ideal candidate will have a Bachelor's degree in Pharmacy and a minimum of 8 years of experience in the pharmaceutical industry. This role requires excellent communication skills and in-depth knowledge of global regulatory requirements.

Qualifications

• Minimum of 8 years of experience in Regulatory Affairs.
• In-depth knowledge of global regulatory requirements and guidelines.
• Proven experience with regulatory submission types.

Responsibilities

• Lead preparation and submission of regulatory dossiers.
• Manage timelines and ensure regulatory milestones are met.
• Serve as the primary contact with regulatory agencies.

Skills

Regulatory submission experience

Communication skills

Regulatory guidance knowledge

Education

Bachelor’s degree in Pharmacy

Job description

Responsibilities

• Lead the preparation, compilation, review, and submission of high-quality regulatory dossiers (e.g., eCTD format) to relevant health authorities.
• Manage timelines and ensure all regulatory milestones and deadlines are met.
• Monitor, interpret, and communicate current and proposed changes in regulatory guidance, legislation, and industry standards to cross-functional teams.
• Oversee the management of regulatory documentation and tracking systems.
• Serve as the primary point of contact and liaison with regulatory agencies for all assigned products/projects.
• Prepare for and participate in meetings, audits, and inspections by regulatory bodies.
• Provide expert regulatory guidance and training to internal stakeholders, including Quality Assurance, Clinical Development, and Commercial/Marketing teams.

Job Requirements

• Bachelor’s degree in Pharmacy.
• Minimum of 8 years of experience in Regulatory Affairs within the pharmaceutical or biotechnology industry.
• In-depth knowledge of global regulatory requirements and guidelines (e.g., FDA, EMA, ICH).
• Proven experience with regulatory submission types.
• Excellent written and verbal communication skills, with the ability to articulate complex regulatory concepts clearly to technical and non-technical audiences.
• Good in English.

391A Orchard Road, Ngee Ann City
Tower A, Unit #23-03
Singapore 238873

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