Regulatory Affairs Manager
3 weeks ago
Job Title: Regulatory Affairs Manager
About the Role:
We are seeking a highly skilled Regulatory Affairs Manager to join our team at Fladger Assoc. Inc. in Gaithersburg, MD. As a key member of our regulatory affairs team, you will be responsible for leading the end-to-end planning, coordination, and execution of assigned deliverables.
About Us:
Fladger Assoc. Inc. is a leading biopharmaceutical company dedicated to making a positive impact on patients' lives. Our vision in Oncology is to help patients by redefining the cancer-treatment paradigm.
About the Job:
The successful candidate will have 1-3 years of Regulatory experience within the Biopharmaceutical industry, or at a health authority, or other confirmed experience. They will possess strong project management skills, leadership skills, including experience leading multi-disciplinary project teams, and a general knowledge of Drug Development.
Responsibilities:
- Leading the end-to-end planning, coordination, and execution of assigned deliverables.
- Contributing to regulatory submission strategy, identifying submission risks and opportunities.
- Providing regulatory expertise and guidance on procedural and documentation requirements.
- Understanding the regulatory framework, including regional trends, for various types of applications and procedures.
Requirements:
- Relevant BS/BA Degree in Science or related field.
- 1-3 years of Regulatory experience within the Biopharmaceutical industry, or at a health authority, or other confirmed experience.
- Strong Project Management skills.
- Leadership skills, including experience leading multi-disciplinary project teams.
What We Offer:
- A competitive salary: $80,000 - $120,000 per annum.
- 100% Remote work option, anywhere in the US, with EST working hours.
- An attractive benefits package, including a fitness center, employee healthcare clinic, electric vehicle charging stations, dry cleaning, full-service cafeteria, copy center, game rooms, community garden, and more.
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