9 дней назад
GRA Labelling Group Lead
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
GRA Labelling Group Lead (Regulatory Affairs): Leading teams that develop and maintain global drug labelling documents and patient leaflets for development, marketed, and life-cycle management products with an accent on regulatory strategy, end-to-end labelling processes, and health authority requirements. Focus on managing complex cross-functional negotiations, guiding submissions and responses to FDA and EMA questions, and balancing people and portfolio capacity across up to 250 products.
Location: Hyderabad, India (Hybrid)
Company
develops medicines and works across pharmaceutical science, regulatory affairs, and patient outcomes.
What you will do
- Lead, recruit, onboard, coach, and develop a team of labelling strategists.
- Plan team capacity, product ownership, workload coverage, contingencies, and resource allocation across a portfolio of up to 250 products.
- Lead the creation and updating of corporate labelling documents, including CCDS, US and EU labelling, WHO documents, and patient leaflets.
- Coordinate end-to-end labelling reviews, regulatory submissions, health authority negotiations, approvals, and product labelling releases.
- Chair multidisciplinary labelling working groups and present proposals to governance committees and senior executive management.
- Provide strategic guidance for complex labelling projects, regulatory responses, competitive analyses, and process-improvement workstreams.
Requirements
- 15+ years of relevant regulatory and drug labelling experience, including major-market marketing authorization filings and marketed-product updates.
- At least 5+ years of people management experience, ideally leading a team of 10 or more, with project and stakeholder management experience.
- Extensive knowledge of CCDS, EU, and US labelling guidance and regulations, including drug-device combinations.
- Proven ability to lead labelling strategy, multidisciplinary matrix teams, negotiations, conflict resolution, and consensus building.
- Experience with labelling and document management systems such as Veeva Vault, EDMS, RIM systems, and text verification or quality-control tools.
- Physician, pharmacist, veterinarian, or life sciences degree; an advanced degree is preferred. Fluent business English required.
Nice to have
- Advanced degree in a relevant life sciences or medical field.
- Experience supporting complex EU and US procedures, including arbitration, referrals, work sharing, PRAC questions, and urgent safety restrictions.
Culture & Benefits
- Work in a hybrid setup in Hyderabad.
- Collaborate with global regulatory, pharmacovigilance, medical affairs, legal, preclinical, CMC, quality, and supply chain functions.
- Support global labelling discussions and local country activities as a global labelling subject-matter expert.
- Work in an inclusive environment with equal-opportunity principles.
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