Regulatory Affair Lead
Ha Noi
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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Pharmaceutical
Job Category:
Pharmaceuticals
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Ha Noi
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