Regulatory Affairs Manager (Pharmaceutical)

About the role

We are partnering with a prestigious pharmaceutical group to hire a Regulatory Affairs Manager reporting to the Head of Regulatory Affairs. The role focuses on strategic planning, regulatory submissions, and communication with global health authorities across discovery, pre‑clinical, and clinical programs.

Key responsibilities

• Develop and implement global regulatory strategies aligned with corporate development plans, staying current on US, EU, China and APAC requirements.
• Lead preparation, authoring, and electronic submission (eCTD) of INDs, CTAs, amendments, safety updates and other dossiers; establish documentation systems and ensure timely archiving.
• Coordinate formal meetings with FDA, EMA, NMPA and other agencies; prepare briefing materials, anticipate questions and interpret feedback for internal teams.
• Partner with pre‑clinical, translational, medical, clinical operations and CMC teams to provide regulatory input into study design, product development and manufacturing; manage external consultants.
• Ensure compliance with FDA, EMA, NMPA, ICH, GCP/GLP/GMP standards; monitor regulatory changes, support audits/inspections and maintain SOPs and policies.
• Assess impact of evolving regulations, recommend mitigation strategies and safeguard audit readiness and regulatory intelligence activities.

Required profile

• Bachelor’s degree in life sciences, pharmacy or related field; advanced degree (MSc, PhD, PharmD) preferred.
• 5+ years of hands‑on regulatory affairs experience in pharmaceutical/biopharmaceutical firms, with exposure to both clinical and CMC activities.
• Experience with early‑stage development programs or novel first‑in‑class therapeutics is highly advantageous.
• Proven track record participating in IND/CTA submissions and interacting with US FDA and China NMPA.
• Fluent written and spoken English with strong communication skills.

Required skills

• eCTD submission platform
• IND and CTA preparation
• FDA, EMA and NMPA interaction
• ICH guidelines
• GCP, GLP and GMP standards