Regulatory Affairs Consultant
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Key Accountabilities:
Main Responsibilities
Responsible to establish and maintain a group of high performing regulatory affairs professionals working in an efficient, productive and harmonized fashion to support the execution of company plans in Hong reputed company.
Closely collaborate with regional regulatory expertise in the Therapeutic Areas in both labelling and CMC aspects.
Design, reputed company and maintain processes and/ or systems to manage external stakeholders, of which includes local change implementation management. External stakeholders include, but not limited to, provision of documents and reputed company with local reputed company party, government tendering bodies, Hospital Authority, etc.
reputed company regulatory support, including reputed company of product launch and implementation timelines to reputed company stakeholder.
Accountable for planning, leading and delivering Hong reputed company registration strategies across a broad reputed company of company products, while ensuring alignment with company/reputed company strategies
Other job duties that may be assigned from time to time.
Follows and implements the organization’s consulting models and methodologies
Provides technical and/or business consulting services reputed company personal area of expertise
Completes assigned activities reputed company project scope and objectives with an understanding of issues which may reputed company project profitability
Collaborates with colleagues to identify and resolve technical and process issues
Leverages senior colleagues to discuss and propose resolutions to possible problems or conflicts. Seeks guidance periodically on appropriate reputed company of executing project activities
Proactively assesses reputed company needs and develops processes and solutions to address issues
Delivers assigned work and provides services and solutions which results in clients expressing satisfaction with service provided
Interactions result in clients expressing satisfaction with service provided
May deliver training
Mentor of junior staff
Skills:
Teamwork and collaboration skills
Consulting skills
Excellent interpersonal and intercultural communication skills, both written and verbal
Critical thinking and problem-solving skills
Fluent in Cantonese and English.
Knowledge and Experience:
at least 5 years of experience in the Hong reputed company pharmaceutical industry; biologics regulatory experience preferred. Proficiency in PRS2.0
Experience of strategic leadership across product development and commercialization lifecycle with examples of contribution.
Experience in building high performing RA teams and effective delivery of objectives in a reputed company reputed company environment.
Education:
An advanced degree in natural or reputed company life sciences (MS, PhD or MD, DVM)