Regulatory Affairs Officer(NOC:1122)
Position:Regulatory Affairs Officer
-This position will be responsible for developing regulatory strategies and plans for J&K‘s pipeline and leading regulatory submissions including IND/CTA/NDA/BLA for pharmaceutical products.
-Medical Device registration, Health Food Registration and Cosmetics products registration in China.
-This position will pursue positive communications and rigorous interaction with CDE/CMDE/cFDA and other regulatory agencies in China when necessary, and ensure development and manufacturing activities meet all relevant requirements and guidelines.
-Additional responsibilities may include compliance, safety oversight/Pharmacological activities and assisting the primary evaluation of potential in-license products, as needed.
– Direct regulatory operations related to regulatory submissions, product development, approval and commercialization in China.
– Primary evaluation for the potential in-license product from Canada, including ask the critical questions to the company and review the critical documentations for the potential license in product.
– Lead regulatory submissions to ensure completeness, accuracy, compliance with agency regulations of China, appropriate scientific rational and strategic impact
– Representing the company with cFDA/CDE/CMDE and regulatory authorities, build and maintain excellent relationships with relevant regulatory agencies, contractors and corporate partners while negotiating company position.
– Identify/assess regulatory risks associated with product development and strategies to mitigate risk
– Monitor/analyze regulatory activities relevant to the company
– Provide regulatory support for various departments, projects , teams/committees.
Education, qualifications, and Work experience:
– Bachelor’s Degree in Science (BSc) degree in Chemistry, Pharmacy or Life Sciences
– Minimum 8 years experience in pharmaceutical regulatory affairs, with at least 3 years of management experience leading teams
– Solid experience with therapeutic products, mainly pharmaceutical
– Detailed knowledge of regulatory requirements in China
– Self-starter and motivated with a desire to collaborate with a globally distributed, virtual team
– Expert communicator
How to ApplyContact information firstname.lastname@example.org
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