R&D - Manager, Regulatory Affairs - BJ

JOB PURPOSE:

• Be accountable for implementing regulatory strategy to obtain the regulatory approval to support various development, manufacturing, sales and marketing activities for the designated product group

• Support line Manager for the HA interaction for the strategy discussion and be accountable for the HA interaction to facilitate the implementation process

ORGANIZATIONAL CONTEXT:

(See Organizational chart attached)

SUPERVISED RESOURCES:

(Sales, budget, headcount…)

KEY ACCOUNTABILITIES:

● Be accountable for implementing regulatory strategy to obtain the regulatory approval to support various development, manufacturing, sales and marketing activities for the designated product

• Lead the submission for the responsible projects or tasks with the guidance of senior regulatory manager

• Collaborate with related functiona at corporate, IA and work with affiliates to support the regulatory activities in the region

• Ensure the high-quality submission with effective communication with agency and internal stakeholders/peers for the assigned projects/tasks

● Suppoert Line Manager or Submission Team leader for the regulatory strategy assessment

• Work with related functions at GRA and China region to develop and implement the regulatory strategy of the responsible projects for the region, aligned with global strategy and regional business strategy

• Work across project team and related workstreams to evaluate, Dossier gap assessment, Regulatory pathway and timelines, RA compliance, Implication of the findings on the deal terms, Ways to mitigate identified risks, implications on cost / time etc.

• Provide the Inputs for strategic projects on RA regulations, requirements, trends

• Provide regulatory intelligence collection and analysis

● Provide Regulatory support to cross-functions to ensure business success

● Ensure regulatory compliance and work in compliance way

JOB-HOLDER ENTRY REQUIREMENTS:

Education:

• Master degree or above in Pharmacy, Medical, Biology or related field (Bachelor is acceptable in special cases)

Experience & knowledge:

• Mimimal 5 years RA experience with tracked record performance in obtaining regulatory approval

• 6+ years industry experience is a plus

Core competencies:

• Good computer skill in EXCEL, POWERPOINT and WORD;

• Good interpersonal communication skill

• Chinese and English (proficiency level) skill both in spoken and written

• Team leader