Associate Director Regulatory Affairs
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Job Location:
New York City, NY - USA
Monthly Salary:
Not Disclosed
Posted on:
30+ days ago
Vacancies:
1 Vacancy
Job Summary
We are looking for an experienced Associate Director Regulatory Affairs to lead and oversee regulatory compliance product registration and regulatory submissions across multiple markets. The role involves ensuring that all products meet FDA regulations EMA guidelines and other international regulatory standards while supporting strategic business objectives.
Key Responsibilities:
Lead the preparation and review of regulatory submissions for product approvals.
Ensure ongoing regulatory compliance with applicable laws guidelines and standards.
Develop regulatory strategies to support new product development and market expansion.
Collaborate with cross-functional teams on clinical trials and quality assurance requirements.
Maintain up-to-date knowledge of FDA regulations EMA guidelines and other global regulatory requirements.
Represent the company in communications with regulatory agencies.
Requirements:
Bachelors or advanced degree in Pharmacy Life Sciences or related field.
8 years of experience in regulatory affairs including leadership roles.
Strong knowledge of regulatory submissions product labeling and compliance processes.
Excellent leadership communication and project management skills.
Ability to work in a fast-paced deadline-driven environment.
Key Skills
- Proofreading
- Adobe Acrobat
- FDA Regulations
- Manufacturing & Controls
- Biotechnology
- Clinical Trials
- Research & Development
- GLP
- cGMP
- Product Development
- Chemistry
- Writing Skills
