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Regulatory Affair Lead

cap LP & Associates' client

location Ha Noi

post time Posted 7 months ago

JOB TITLE: Regulatory Affairs Lead (RA Lead)
DEPARTMENT: Regulatory Affairs
SUPERVISOR: Associate Director, Regulatory Affairs, APAC
POSITION LOCATION: Hanoi
 
 

1. POSITION OBJECTIVE

Support local RA team and company efforts in maintaining internal and external regulatory compliance
Responsible for development and execution of regulatory strategies for new products and life cycle maintenance of licenses in support of country business needs


2. POSITION DUTIES & RESPONSIBILITIES
Work closely with local RA team to meet country KPIs
Coordinate and the prepare of documents/packages for regulatory submissions
Compile regulatory documents for submission following local requirements
Review, edit and proofread regulatory documentation
Compile and prepare responses to regulatory authority questions
Track status and progress of regulatory documentation
Assist in preparation, review and training if necessary of labelling, SOPs, and other departmental documents
Monitor applicable regulatory requirements; assure compliance with the company’s and external standards
Maintain regulatory files in a format consistent with requirements
Establish communication and good working relationships within RA, other functions and the health authorities
Review and approve promotional materials to ensure compliance with company and external standard.
Participate as an active team member of local, regional and global project teams as required.

 

3. SKILLS & QUALIFICATIONS

Educational Background/Experience:
Bachelor’s degree in pharmacy with 4-5 years regulatory experience in a pharmaceutical regulatory affairs role

Qualifications/Competencies:
Strong oral and written communication and presentation skills
Knowledge of regulations
Ability to independently identify compliance risks and escalate when necessary
Demonstrated interpersonal skills including strong negotiation skills
Scientific knowledge
Ability to manage complex projects and timelines in a matrix team environment
Ability to multitask and prioritize
Technical systems skills (e.g. word processing, spreadsheets, databases, online research)
Proofreading and editing skills

4. CHALLENGES
Effectively managing key stakeholders’ expectations
Time management
Possible travel outside of usual business hours

 

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company detail


200-300 employees


Pharmaceutical


Pharmaceuticals


Full Time


Ha Noi


English


Khác


English and Vietnamese


144 Phung Van Cung Str., Ward 4, Phu Nhuan Dist., HCMC.


Ms. Nhu Thuyen


(+8428) 2253 2930 , Ext : 604


lanphuong@lp-a.com.vn phuong.lan.nguyen@natopjobs.com.vn recruitment@natopjobs.com.vn nhuthuyen@lp-a.com.vn