Section Manager, RA - lonza

Job Reference: HH100
Employer/Agency: lonza
Location: Singapore
Experience:
Salary/Package: On application
Job Sector: General Management & Consulting
Date Posted:
Closing Date:

At Lonza, we invest in great people. We encourage our employees to challenge themselves and we offer an environment that fosters creativity and success. Headquartered in Basel, Switzerland, we operate production, R&D, and business sites around the world, including Europe, North America, and Asia.
Our vision:
We strive to be the leading supplier using science and technology to improve the quality of life.
Our mission:
We work with passion, using advanced technologies, to transform life science into new possibilities for our customers.

Do you want to help us as we shape the future of this great organization?

Job Description Summary
Frontline advisor for regulatory issues to customers and internal SMEs; Service provider for regulatory filings to customers; APAC contact for regulatory intelligence to Lonza Regulatory Affairs network; Single contact point for regulatory affairs to regulatory authorities

Job Description
Responsibilities
Frontline advisor for regulatory issues to customers and internal SMEs
Service provider for regulatory filings to customers
Regional, Asian-Pacific (APAC), analyzer and contributor for regulatory intelligence to Lonza Regulatory Affairs (RA) network
Contact point for regulatory affairs to regulatory authorities.
Key Accountabilities and Duties:
Customer Supports: including regulatory technical writing, regulatory filing, and regulatory authority communications
Internal Supports: including regulatory assessments and consultation services
RA Network Supports: Supporting activities initiated/ managed by LPB Regulatory Affair network.
Education and Work Experience
Degree in Life Sciences in Chemistry/ Biology/ Biochemistry/ Pharmacy or Equivalent
5 years of pharmaceutical industry experience
Experience of preparing, authorizing or submission of IND/IMPD, NDA/BLA for biologics is preferable
Working knowledge of APAC, US or EU regulatory requirements for biologics is preferable
Responsibilities
All Lonza Biologics Employees have the following responsibilities:
Quality should be the responsibility of all persons involved in Manufacturing. Adherence to cGMPs is required at all times during the manufacture of APIs.
All personnel are responsible for notifying responsible Management in a timely manner of regulatory inspections, serious GMP deficiencies, product defects and related actions (e.g. quality related complaints, recalls, regulatory actions, etc.)
All personnel should practice good sanitation and health habits.
Personnel suffering from an infectious disease or having open lesions on the exposed surface of the body should not engage in activities that could result in compromising the quality of APIs.
All personnel are required to provide support in maintaining the site safety, health and environmental programs and system.
Adherence to SHE rules and regulations is required at all times.

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