обновлено 9 часов назад
Regulatory Affairs Manager (Pharmaceuticals)
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
Regulatory Affairs Manager (Pharmaceuticals): Developing and executing regulatory strategies for a diverse pharmaceutical portfolio, including product registrations, submissions, labeling updates, and lifecycle management, with an accent on Turkish pharmaceutical regulations, compliance, and health authority engagement. Focus on leading complex regulatory projects, managing regulatory risks, and coordinating cross-functional teams across Medical Affairs, Quality, Supply Chain, Legal, Market Access, and Commercial.
Location: Istanbul, Turkey; hybrid schedule with 3 days in the office and 2 days from home
Company
Johnson & Johnson Innovative Medicine develops science-based pharmaceutical treatments and supports products across the path from laboratory research to patient access.
What you will do
- Develop and execute regulatory strategies for new products, indications, renewals, and lifecycle management activities.
- Lead the preparation, review, submission, and approval tracking of regulatory dossiers, marketing authorization applications, variations, and renewals.
- Manage labeling updates, approved changes, product launches, and regulatory documentation.
- Monitor regulatory developments, assess risks and opportunities, and communicate their potential business impact.
- Engage with health authorities, industry associations, and internal and external stakeholders.
- Represent Regulatory Affairs in cross-functional value teams and collaborate with Medical Affairs, Supply Chain, Quality, Legal, Market Access, Government Affairs, Commercial, and Global Regulatory teams.
Requirements
- Bachelor’s degree in Pharmacy, Chemistry, Chemical Engineering, Life Sciences, or a related discipline.
- At least 8 years of Regulatory Affairs experience in the pharmaceutical industry.
- At least 2–3 years of experience as a Regulatory Affairs Manager, including complex regulatory projects and cross-functional collaboration.
- Strong knowledge of Turkish pharmaceutical regulations and regulatory procedures.
- Experience in regulatory strategy, submissions, lifecycle management, stakeholder management, compliance, and risk assessment.
- Fluent English and Turkish, with strong communication, influencing, leadership, planning, and organizational skills.
Culture & Benefits
- Inclusive work environment grounded in the company’s Credo values.
- Opportunity to contribute to treatments, cures, and patient access within Innovative Medicine.
- Hybrid working model with three office days and two home-working days per week.
- Collaboration with local, regional, and global stakeholders.
- Participation in knowledge sharing, continuous improvement, and operational excellence initiatives.
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