Job Description:

Job Title:            Regulatory and Strategic Development Specialist

Job Location:    China

Job Overview:    

A Senior Specialist of Regulatory and Strategic Development will be responsible for preparing regulatory submissions and assist with managing project timelines for allocated projects including regulatory authority licenses, registrations, exemptions, designations, applications or authorizations for marketing and sale of a drug product or for the use of an investigational drug in human subjects.

This position will ensure maintenance and control of all regulatory submission documentation and assist with developing regulatory plans and strategies for emerging and mid-tier life science client companies including timelines and reporting and tracking of regulatory deliverables.

The position may include client and regulatory authority liaison and requires good technical and verbal and written communication skills.

Job Duties and Responsibilities: 

Core:

• Assist with compilation and review of regulatory documentation and submissions.
• Liaise with internal Publishing group for the preparation of electronic submissions for regulatory authorities.
• Ensure regulatory documentation and submissions are in compliance with respective authorization(s) and GXP/ICH, regional or country specific requirements.
• Maintain and assist with developing client regulatory plans including timelines, submission documentation, communication, and reporting and tracking of regulatory deliverables.
• Liaise with regulatory authorities, clients, contractors, consultants and vendors, as required.
• Participate in internal and client project team meetings.

• Participate in meetings with regulatory authorities, as needed.

   

Supervisory Responsibilities:
- No supervisory responsibilities.

Education:
- Bachelor’s degree in a life or medical sciences or relevant scientific background with responsibility.
 

Experience
- 3+ years’ work experience commensurate with functional area of responsibility; or combination of work experience, education or other related industry experience in similar role.
- Experience working in academic, pharmaceutical, biotechnology or CRO industry is preferred.

Skills/Competencies
- Oral communication: Speaks clearly and persuasively in positive or negative situations, demonstrates group presentation skills and conducts productive meetings.
- Safety and security: Observes safety and security procedures and uses equipment and materials properly.
- Quality management: Looks for ways to improve and promote quality and demonstrates accuracy and thoroughness.
- Problem solving: Identifies and resolves problems in a timely manner and gathers and analyzes information skillfully.
- Planning/organizing: Prioritizes and plans work activities, uses time efficiently and develops realistic action plans.

Capabilities
- Good written and verbal communication skills. Good interpersonal skills. Good computer skills, including Microsoft Office.

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The company will not accept unsolicited resumes from third party vendors.