Primary Function:

The Regulatory Affairs Senior Manager/Associate Director will provide regulatory expertise to support the planning of IND enabling activities, development of regulatory strategies, and lead the preparation and submission of IND/CTA and NDA/BLA dossiers in China, US, EU countries, etc., as well as interactions with the regulatory authorities.

Major Responsibilities and Duties:

• Provide expert regulatory input into the planning of IND enabling activities.
• Lead the preparation and submission of IND/CTA and NDA/BLA dossiers and interactions with regulatory authorities in China, US, EU countries,
• Provide regulatory review and approval of responses required by NMPA, FDA and EMA, and/or authorities of other countries/regions.
• Provide input into assigned sections of the Clinical Development Plan, with appropriate regulatory strategies in the view of global development (for Associate Director).
• Collaborate with internal cross-functions and external partners to ensure smooth progress of the assigned projects or tasks.
• Maintain the process and/or system related to regulatory submission and archiving.

Qualifications:

• Bachelor and above in Medical or Pharmaceutical Science or equivalent.
• Possess significant regulatory affairs experience (5-8 years for Sr. Manager; more than 8 years for Associate Director) gained from the Pharmaceutical or Biotech industries (or related).
• Experience of pre-IND and IND submission to NMPA and FDA.
• Well-developed communication skills in both English and Mandarin.
• Project management skills are plus.
• Ability to travel up to 10-20% of the time domestically and internationally.