обновлено 4 дня назад
Execution Hub Associate (Pharmaceutical Regulatory Affairs)
Вакансия из Hirify Global, списка международных tech-компанийДля мэтча и отклика нужен Plus
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Execution Hub Associate (Pharmaceutical Regulatory Affairs): Supporting end-to-end regulatory dossier management for pharmaceutical products across initial registrations, lifecycle changes, and product withdrawals with an accent on local M1 document authoring, submission preparation, and quality compliance. Focus on coordinating regulatory requirements, reviewing dossier content, responding to health authority queries, and improving execution efficiency across country and regional teams.
Location: Hybrid in Makati City, Philippines
Company
is a global pharmaceutical company developing and delivering medicines and vaccines.
What you will do
- Manage or support multi-regional, regional, and national regulatory dossiers from initial registration through lifecycle management and product withdrawal.
- Author, review, coordinate, and deliver local M1 dossier components, including cover letters, variations, marketing authorization applications, translations, labels, and artwork updates.
- Identify regulatory requirements and prepare submission-ready documents in partnership with Country Regulatory Strategists and Hub Submission/Dossier Managers.
- Review and approve dossier tables of contents and support simple health authority query responses.
- Support tenders, out-of-stock reporting, annual product quality reviews, risk minimization plans, launch planning, audit readiness, and medical information requests.
- Identify and escalate quality, compliance, and emerging regulatory risks while improving portfolio execution efficiency.
Requirements
- B.S. in Pharmacy or equivalent relevant professional experience.
- Advanced to fluent English is required.
- Technical aptitude and ability to learn new software, regulations, and quality standards quickly.
- Advanced Microsoft Office Suite skills.
- Experience or understanding of pharmaceutical regulatory, quality, or compliance work is preferred.
- Understanding of country or cluster regulatory requirements and trends, as well as pharmaceutical organizational structures and systems, is preferred.
Nice to have
- Multilingual skills, such as Korean.
- Experience supporting regulatory activities across initial applications, commercial lifecycle management, audits, tenders, and launch planning.
- Subject matter expertise in projects affecting people, technology, or processes within regulatory operations.
Culture & Benefits
- Hybrid work arrangement in Makati City.
- Collaboration with country regulatory teams, regional submission hubs, and cross-functional subject matter experts.
- Opportunity to contribute to international regulatory operations, compliance, and process efficiency.
- Equal employment opportunity in accordance with applicable local legislation.
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