Associate Manager, Regulatory & Strategic Development

Job Title:            Associate Manager, Regulatory & Strategic Development

Job Location:    China, office based or homebased

Job Overview:  

An Associate Manager of Regulatory and Strategic Development will be responsible for preparing regulatory submissions and 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 strong technical and verbal and written communication skills.

The position may include the supervision and management of regulatory professionals and support personnel.

Job Duties and Responsibilities:

Core:

• Prepare technical content for 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.
• Provide regulatory guidance internally to project teams, functional areas and externally to clients.
• Maintain and assist with developing client regulatory plans including timelines, submission documentation, communication, and reporting and tracking of regulatory deliverables.
• Assist in the development of regional and/or global strategic plans for the development of client drug product.
• 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.
• Provide training for internal personnel and supervise staff, as required.

US add'l:

• None

EU add'l:

• Mother tongue (Swiss)-German
• Experience with regulatory affairs in Europe and Switzerland

APAC add'l:

• None

Supervisory Responsibilities:

Directly supervises employees if required. Carries out supervisory responsibilities in accordance with the organization's policies and applicable laws.  Responsibilities include interviewing, hiring and training employees; planning, assigning and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.

Job Requirements:

• Education
• Core:
  • Bachelors’ degree in area of concentration commensurate with responsibility.
• US add'l:
  • Post-graduate degree and leadership role in academia or in pharmaceutical industry highly desirable.
• EU add'l:
  • Post-graduate degree (MSc or PhD) and leadership role in academia or pharmaceutical industry highly desirable.
• APAC add'l:
  • None
• Experience
  • 5+ 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 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.
  • Analytical: Synthesizes complex or diverse information.
  • Judgment: Displays willingness to make decisions, exhibits sound and accurate judgment and makes timely decisions.
  • Mentor/Teacher: Demonstrates a willingness to organize and explain complex regulatory or compliance concepts. Has made the growth and development of others a priority.
• Capabilities
  • Strong written and verbal communication skills.  Strong interpersonal skills.  Strong computer skills, including Microsoft Office.

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