Job opening - Associate Director, Regulatory Affairs in Hong Kong | Randstad Hong Kong

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summary

hong kong
randstad hong kong
permanent
full-time

specialism
life sciences
sub specialism
regulatory affairs
reference number
91M0203024_3515778138159452470

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job details

about the company.

Our client, a world-class leading pharmaceutical manufacturing company, is currently looking for an Associate Director, Regulatory Affairs to join their expanding team.

...

about the job.

Provides input into global regulatory strategy and contributes to Regulatory Functional Plan (RFP) and Seed Document, or their equivalents, including identification of gaps or risks in global strategic plan for assigned regions
Determines requirements and sets objectives for Health Authority (HA) interactions with DRA GPT representatives and/or GTAL
Facilitates preparation and finalization of briefing books and contributes to preparation of summary documents. -Develops and implements plans for timely response to HA requests and coordinates responses
May serve as local HA liaison depending on location (e.g., FDA or EMA).
Drives coordination, planning, and submission of dossiers in assigned regions worldwide. -Review of global dossier summary documents.
Reviews, approves and submits Clinical Trial Applications (CTAs) and Investigational New Drugs (INDs)
Reviews and submits Risk Management Plans. -May lead negotiations for regional approvals independently or with DRA GPT representative and/or GTAL
Reporting of technical complaints / adverse events / special case scenarios related to the company’s products within 24 hours of receipt -Distribution of marketing samples (where applicable)

skills & experiences required.

Bachelor’s degree or above in health/life sciences. Doctoral degree preferred (PharmD, PhD, MD)
Proficient in English and Cantonese (Mandarin is a plus)
Ability to successfully maximize new technology/digital/IT solutions for effective partner mapping, development, management, and field medical insights gathering
Strong commercial sense including innovative, solution-oriented, and critical thinking with performance-focused drive to achieve objectives and implement tactics

Interested individuals can click apply now and send through an updated resume in WORD format. For a more comprehensive list of current opportunities, please visit https://www.randstad.com/jobs/q-hong-kong/ or contact Jessica Cheung at + 852 6285 6991 or email jessica.cheung@randstad.com.hk

#humanforward

show more

about the company.

Our client, a world-class leading pharmaceutical manufacturing company, is currently looking for an Associate Director, Regulatory Affairs to join their expanding team.

about the job.

Provides input into global regulatory strategy and contributes to Regulatory Functional Plan (RFP) and Seed Document, or their equivalents, including identification of gaps or risks in global strategic plan for assigned regions
Determines requirements and sets objectives for Health Authority (HA) interactions with DRA GPT representatives and/or GTAL
Facilitates preparation and finalization of briefing books and contributes to preparation of summary documents. -Develops and implements plans for timely response to HA requests and coordinates responses
May serve as local HA liaison depending on location (e.g., FDA or EMA).
Drives coordination, planning, and submission of dossiers in assigned regions worldwide. -Review of global dossier summary documents.
Reviews, approves and submits Clinical Trial Applications (CTAs) and Investigational New Drugs (INDs)
Reviews and submits Risk Management Plans. -May lead negotiations for regional approvals independently or with DRA GPT representative and/or GTAL
Reporting of technical complaints / adverse events / special case scenarios related to the company’s products within 24 hours of receipt -Distribution of marketing samples (where applicable) ...

skills & experiences required.

Bachelor’s degree or above in health/life sciences. Doctoral degree preferred (PharmD, PhD, MD)
Proficient in English and Cantonese (Mandarin is a plus)
Ability to successfully maximize new technology/digital/IT solutions for effective partner mapping, development, management, and field medical insights gathering
Strong commercial sense including innovative, solution-oriented, and critical thinking with performance-focused drive to achieve objectives and implement tactics

Interested individuals can click apply now and send through an updated resume in WORD format. For a more comprehensive list of current opportunities, please visit https://www.randstad.com/jobs/q-hong-kong/ or contact Jessica Cheung at + 852 6285 6991 or email jessica.cheung@randstad.com.hk

#humanforward

show more

skills
no additional skills required
qualifications
no additional qualifications required
education
Bachelor Degree

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jessica cheung

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