22 часа назад
Associate Director, Global Medical & Promotional Regulatory Affairs
160 000 - 240 000$
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
Associate Director, Global Medical & Promotional Regulatory Affairs (Pharmaceutical Regulatory Affairs): Leading promotional material review and regulatory strategy for oncology products in the US with an accent on FDA compliance, advertising and promotional communications, and cross-functional review. Focus on chairing PMRC meetings, submitting materials to FDA/OPDP, advising on promotional tactics, and managing regulatory interactions for product launches.
Location: California — Remote/Home-Based; US-based candidates only
Salary: $160,000–$240,000 annual base pay for US-based candidates, with potential bonus, equity, and benefits.
Company
is a global biopharmaceutical company developing medicines for serious diseases, with a portfolio spanning sleep disorders, epilepsy, oncology, and neuroscience.
What you will do
- Lead the Promotional Material Review Committee for assigned US products and therapeutic areas.
- Direct regulatory review and approval of advertising, promotional, and non-promotional materials.
- Chair review meetings and coordinate decisions with Regulatory, Medical Affairs, Legal/Compliance, Marketing, and Commercial stakeholders.
- Submit promotional materials to the FDA Office of Prescription Drug Promotion in a timely manner.
- Provide regulatory support for Medical Affairs Review Committee and publications reviews.
- Lead FDA/OPDP interactions and contribute to regulatory strategy and product launch activities.
Requirements
- Bachelor’s degree in a scientific discipline or equivalent combination of education and pharmaceutical industry experience.
- Substantial progressively responsible experience in the pharmaceutical industry.
- Direct experience reviewing advertising and promotional materials is required.
- Strong understanding of FDA regulations and guidelines.
- Strong judgment, decision-making, collaboration, and written and verbal communication skills.
- Ability to work autonomously and collaboratively across functions.
Nice to have
- Advanced degree in a scientific discipline, such as a PharmD.
- Experience in oncology or another relevant therapeutic area.
- Experience supporting new product launches and accelerated-approval products.
Culture & Benefits
- Remote/home-based work arrangement for the role.
- Medical, dental, and vision insurance for eligible US-based employees.
- 401(k) retirement savings plan.
- Flexible paid vacation.
- Potential annual cash bonus or incentive compensation and discretionary equity grants.
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