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Regulatory Affairs

Regulatory Affairs

CisemaKuala Lumpur, Kuala Lumpur, Malaysia
16 hours ago
Job description

A seasoned Regulatory Affairs & Product Development Strategist to provide consulting services. This role requires deep expertise in Regulatory Affairs, CMC, and Clinical & Product Development, with a strong understanding of the Chinese regulatory landscape and global frameworks. The role will advise clients across the drug development lifecycle, shape regulatory strategy, support submissions, optimize CMC processes, and provide guidance on clinical and product development initiatives.

This role demands exceptional leadership, strategic acumen, and a results-driven mindset, a professional who not only navigates complexity but also defines the roadmap for innovation and regulatory excellence in the life sciences sector.

Key Impact Areas :

Regulatory Affairs Strategist & LCM

  • Define and execute regulatory strategies for IND / CTA, NDA, MAA, BLA, and ANDA, ensuring seamless approvals.
  • Guide clients on priority review pathways, fast-track approvals, and strategies to optimize regulatory submissions.
  • Spearhead interactions with regulatory authorities; guiding, preparing and attending pre-IND and pre-NDA meetings.
  • Oversee submission best practices and help mitigate regulatory challenges.
  • Support Labeling and packaging materials development and update.
  • Experience in Pharmacovigilance execution.
  • Lead lifecycle management strategies, ensuring compliance and sustained market viability.

CMC Excellence & Strategy

  • Provide expert guidance on manufacturing processes, technology transfer, and process validation.
  • Lead clients through CMC-related regulatory filings, ensuring high-quality submissions.
  • Advise on formulation development, analytical methods, and compliance with NMPA and global regulatory standards.

    • Clinical Development Strategy and Execution

  • Design integrated clinical development strategies aligned with regulatory and commercial goals.
  • Guide clients through clinical trial design, execution, and post-market surveillance.
  • Oversee product development lifecycle management, including market expansion and commercialization strategies.
  • Provide strategic input on formulation development and scalability for manufacturing.
  • Lead interactions with CROs, vendors, and regulatory bodies, ensuring flawless execution and compliance.
  • Provide deep insights into market expansion opportunities, driving competitive advantage.

    • Qualifications & Leadership Profile :

  • 15+ years of executive-level experience in Regulatory Affairs / CMC, and Clinical Development.
  • Proven track record of developing regulatory and clinical strategies and driving successful submissions and approvals in China and global markets.
  • Experience in leading teams and project management within life sciences.
  • Previous experience at a director level or above in an MNC or consultancy (CRO / CDMO experience) preferred.
  • Registered Pharmacist, preferred.
  • Expertise in small molecules, biologics, combination products, and ATMPs.
  • Fluency in English and Chinese (Mandarin) for strategic client and regulator interactions.
  • An entrepreneurial mindset, capable of handling both strategic leadership and administrative tasks.
  • PhD or prior health authority experience (preferred but not mandatory).
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    Regulatory • Kuala Lumpur, Kuala Lumpur, Malaysia