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Regulatory Affairs Manager

Your role:

Take Reg-CMC role for chemical products under clinical development and marketed in China. Support line manager to coordinate CMC regulatory activities with internal and external stakeholders. inlcuding:

1.Provide CMC expertise and develop CMC strategy through all stages of imported drug product development (CTA, NDA and subsequent renewals/variations);

2.Assess and communicate CMC regulatory requirements with internal partners to ensure all CMC submissions are in compliance with applicable regulations and guidelines;

3.Update the organization on the evolving CMC regulatory requirements to ensure all relevant divisions/functions understand the impact and implications and take appropriate actions;

4.Engage and interact with regulatory agencies to reach aligned pathways/solutions for all CMC and QC related issues;

5.Coordinate and align with global team to ensure adequate global support and input in CMC and QC related issues;

6.Drive decision making through communication and alignment across multiple functions/divisions;

7.Interact with all TAs internally to ensure consistent and aligned approaches in CMC and QC related issues. Coordinate the preparation of CMC responses to regulatory agencies;

 

Who you are:

5-8 years working experience on Regulatory Affairs in Pharma company.

 

HR95598

functional area: Regulatory & Medical Affairs

Job Requisition ID:  189330
Location:  Beijing - all
Career Level:  D - Professional (4-9 years)
Working time model:  full-time

US Disclosure
The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law.  This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.

North America Disclosure
The Company is committed to accessibility in its workplaces, including during the job application process. Applicants who may require accommodation during the application process should speak with our HR Services team at 855 444 5678 from 8:00am to 5:30pm ET Monday through Friday.


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