Regulatory Affairs Manager

Website AnHeart Therapeutics

Department: Regulatory Affairs
Report to: Regulatory Affairs Director

MAIN RESPONSIBILITIES:
Be accountable for developing a regulatory strategy for the responsible projects under the guidance of the line manager.
Be accountable for the regulatory strategy implementation by regulatory submission/approval.
Make sure the line manager is fully informed of product registration status in daily work.
Independently engage with internal and external stakeholders to follow up on every milestone closely to ensure issues are identified and escalated to the line manager timely.
Proposed solution on issues and discussed with line manager on your proposal.
Make sure that the target filing and approval timeline plan is achieved.
Establish and maintain a good relationship with the key regulatory authorities in daily work such as NMPA, CDE, NIFDC, CPC, etc via professional communication.
Support line manager on budget planning and monitoring in daily work.
Follow up on new guidelines, policies, and regulations by health authorities such as FDA, EMA, as well as NMPA. Update the project teams and propose activities to ensure full compliance with the regulatory policies, guidelines, and regulations.
Other duties as assigned based on company needs, such as the SOP system establish, and the eCTD system establish.

QUALIFICATIONS:

B.S. or above in Pharmaceutical sciences, Pharmacy, Medical, Biology, Chemistry, or related field;
At least 6 years of experience in the Bio/Pharma industry, experience in drug/biologic manufacturing is a plus;
About 3 years experience in RA functions, with successful experience in regulatory documents preparation, submission, and approval, such as IND or NDA, BLA;
Proven ability to communicate (written/oral) with various functions and with authority;
The ability of cross-functional co-operation. Strong ownership and cross-boundary working mindset;
A capability in problem-solving;
Business level English both oral and written.

 

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