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.
- 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.