Regulatory Affairs Consultant
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Job Location:
Monthly Salary:
Posted on:
3 days ago
Vacancies:
1 Vacancy
Job Summary
When our values align theres no limit to what we can achieve.
At Parexel we all share the same goal - to improve the worlds health. From clinical trials to regulatory consulting and market access every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.
Each of us no matter what we do at Parexel contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally we do it with empathy and were committed to making a difference.
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 Kong.
Closely collaborate with regional regulatory expertise in the Therapeutic Areas in both labelling and CMC aspects.
Design deploy 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 liaison with local third party government tendering bodies Hospital Authority etc.
Provide regulatory support including oversight of product launch and implementation timelines to internal and external stakeholder.
Accountable for planning leading and delivering Hong Kong registration strategies across a broad range of company products while ensuring alignment with company/commercial strategies
Other job duties that may be assigned from time to time.
Consulting Activities and Relationship Management
Follows and implements the organizations consulting models and methodologies
Provides technical and/or business consulting services within personal area of expertise
Completes assigned activities within project scope and objectives with an understanding of issues which may impact 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 methods of executing project activities
Proactively assesses client 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:
5 years of experience in the Hong Kong pharmaceutical industry; biologics regulatory experience preferred. Proficiency in PRS2.0
Experience of strategic leadership across product development and commercialisation lifecycle with examples of contribution.
Experience in building high performing RA teams and effective delivery of objectives in a complex matrix environment.
Education:
An advanced degree in natural or related life sciences (MS PhD or MD DVM)
Required Experience:
Contract
Key Skills
- Proofreading
- Adobe Acrobat
- FDA Regulations
- Manufacturing & Controls
- Biotechnology
- Clinical Trials
- Research & Development
- GLP
- cGMP
- Product Development
- Chemistry
- Writing Skills
About Company
Parexel is in the business of improving the world’s health. We do this by providing a suite of biopharmaceutical services that help clients across the globe transform scientific discoveries into new treatments. From clinical trials to regulatory, consulting, and market access, our the ... View more
