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Job Details

Regulatory Affairs Director (CMC)

Company: i-Pharm Consulting
Location: Hong Kong
Reference: EB8657
Closing Date: 21 Nov 17
Type: Permanent
Salary (£): Negotiable
Benefits:

Job Summary:

This is an exciting opportunity for Regulatory Affairs professionals to lead the global registrations of the company's portfolio.

Requirements:

JOB TITLE: Regulatory Affairs Director (CMC)

LOCATION: Hong Kong

BENEFITS
Attractive Base Salary
AWS
Performance Bonus
Shares
Relocation Entitlement


ROLE/DESCRIPTION

The Director for CMC position will lead the development and execution of robust, risk-based regulatory CMC strategies for high profile programs, mentor, and provide direction to regional regulatory team members. You will be responsible for all aspects of CMC regulatory decisions.

You will provide strategic leadership, communicate and coordinate regulatory strategy, risks, and issues to the Global Regulatory team members, collaborate with the site and regional RA network to develop and execute regional regulatory activities with respect to preparation of submissions and other regulatory deliverable. Accountable and responsible for all local regulatory bodies in APAC region with focus on Japan, China, and India market.

You will identify the need for process and strategy changes to meet the company’s initiatives and changes in external regulatory policy and guidance.

Report the needs for CMC processes and systems improvement, incorporate changes in external regulatory guidance, and communicate all issues and progress to RA CMC product team management.


REQUIREMENTS

You will hold a minimum Master’s degree with over 5 years of Regulatory CMC management experience in biotech manufacturing, testing (QC/QA or clinical), or distribution.

Your regulatory CMC experience will be gained from site, product, or regional submission contributions (CTAs, MAs, variations, briefing documents, etc.). Detailed knowledge and experience in APAC regulatory strategy development, functional presentations, system and process competency, regulatory intelligence and policy analysis.

Experience leading critical projects in a regional complex matrix environment, with a strong understanding of business trends and objectives.

Working as an individual contributor in a medium size Regulatory network, it is important that you possess a strong interpersonal and organization skills, with project management techniques and ability to collaborate with cross-functional product team management.


ABOUT i-PHARM CONSULTING

i-Pharm Consulting is a specialist Recruitment Company servicing the global Pharmaceutical industry. We provide both permanent and contract staff to a wide range of Pharmaceutical, Medical Device, Biotechnology and Contract Research Organisations (CROs). i-Pharm has specific expertise in Clinical Research, Medical Affairs, Regulatory Affairs, Pharmacovigilance, Quality Assurance and Bioinformatics.

www.i-pharmconsulting.com


TO APPLY

If you would like to discuss this vacancy further, please call Senior Consultant, Edward Buenaventura on +65 3163 3101, or email ebuenaventura@i-pharmconsulting.com. If this role is not suitable, Edward is also available to discuss other possible positions or answer any general questions regarding your career and the current market.


KEY WORDS
Regulatory Affairs / CMC / drug development / filing / submission / regulatory strategies / regional / marketing applications / JAPAC / Hong Kong /

Apply for this job: Regulatory Affairs Director (CMC)

Contact Information:

Address:  Head Office
212 New King’s Road London
SW6 4NZ
England
Reasons to work for i-Pharm Consulting
Tel:  +44 (0) 20 3189 2299
Website:  Visit Our Web Site

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