Regulatory Affair Lead
LP & Associates' client
Ha Noi
Posted
60 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
Fields marked with a * are required.
Company Size:
200-300 employees
Industry:
Pharmaceutical
Job Category:
Pharmaceuticals
Job Type:
Full Time
Location:
Ha Noi
Desired skills:
English
Job Level:
Khác
Preferred language to receive applications:
English and Vietnamese
Company address:
144 Phung Van Cung Str., Ward 4, Phu Nhuan Dist., HCMC.
Contact name:
Ms. Nhu Thuyen
Phone number:
(+8428) 2253 2930 , Ext : 604
Email address:
lanphuong@lp-a.com.vn
phuong.lan.nguyen@natopjobs.com.vn
recruitment@natopjobs.com.vn
nhuthuyen@lp-a.com.vn