Manager Regulatory Affairs

General Responsibilities:

• Oversee the regulatory applications of pharmaceutical products Advance Therapeutic products Chinese medicinal products medical devices.
• Coordinate and manage simple and complex regulatory submissions in accordance with applicable regulations; this includes ability to translate regulatory requirements into practical workable submission plans; develop & maintain timelines; coordinate internal/ external authoring/ review/ comment adjudication and finalization (submission and archival).
• Provide leadership to Regulatory Team by ensuring that appropriate structures systems competencies and values are developed.
• Actively participate analyze follow-up and discuss with clients on relevant issues.
• Establish ongoing liaison with key government officials and ensure that significant developments in the field are identified and monitored.
• Ensure effective team communication throughout Regulatory Team through the application of suitable reporting systems structures and the identification and provision of appropriate training.
• To have overall responsibility for ensuring that all regulatory requirements are addressed are dealt with in accordance with company SOPs and international standards.
• Review promotional materials to ensure compliance with regulations and company standards.
• Collaborate with clients and internal marketing teams on regulatory submission and product variation management.
• Act as the point of contact between local regulatory authority and the company on regulatory affairs matters.

Job Requirements:

• Degree holder in Pharmaceutical Science Life Science with or related discipline
• Minimum of 8 years relevant experience in pharmaceutical industry
• Registered Pharmacist in Hong Kong is preferable
• Well-versed in the Hong Kong pharmaceuticals regulatory requirement
• Independent self-motivated proactive reliable and organized with attention to detail
• Excellent command of both written and spoken English and Chinese
• Candidate with less experience will be considered as Assistant Manager Regulatory Affairs

Why its Great to work at DKSH

At DKSH we are driven by a purpose that goes beyond the ordinary: enriching peoples lives. Through the products and services we provide DKSH positively impacts millions of lives everyday. Join our team where entrepreneurship meets flexible work arrangements. Take the leap and start a journey where you can grow and make a difference!

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