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Job Description:

Summary of Job Responsibilities:

• Develop regulatory strategies to support new products development and life cycle management.
• Deliver timely regulatory filings and approvals.
• Lead HA interactions, including consultation meetings and response to HA queries

Dimensions of Job:

• Develop optimized regulatory strategies for new products
• Deliver timely regulatory filings and approvals
• Provide regulatory insights to cross functional team in R& D and commerical for assigned projects
• Establish good relationship with HA and collaborate with key stakeholders in the local, regional and global organization
• Perform with high quality and compliance

Principal Accountabilities of Job:

• Develop and implement the optimal regulatory strategies for new products development and life cycle management.
• Deliver on-time and high-quality submissions and approvals for CTA, NDA/BLA, variation, renewal, etc.
• Serve as the primary liaison with regulatory agencies. Lead HA meetings and oversee their preparations. Drive the responses to HA queries and ensure effective communication with HA.
• Monitor and interpret changes in drug registration related regulations and guidelines, and assess their impacts on existing products and future developments..
• Identify the regulatory risks and work with cross functional team to generate mitigation plans.
• Ensure regulatory activities in compliance with the regulations, company rules and RA department’s SOPs.

Key Performance Measures:

• Time to Approval
• Regulatory Compliance Audits
• Stakeholder Satisfaction

Qualifications & Competencies

• Master’s degree or above in chemistry, pharmaceutics, biology or a related life-science discipline.
• > 5 years of regulatory affairs experience in a multinational pharmaceutical company.
• Strong lobby/negotiation capability and excellent communication skill; excellent leadership with team spirit; high learning ability and willing to work under high pressure.
• Have good communication with HA.
• Fluent English in verbal and written; good computer skill, good presentation skill.

Other Requirements

• Credo based behavior with regulatory compliance excellence.