Associate Director, Regulatory Affairs

📋 Description

• Oversee, assess, and execute regulatory projects.

• Formulate, implement, and provide guidance on regulatory strategies.

• Accountable for steering decision-making processes and resolving conflicts.

• Supervise the preparation and submission of necessary documentation.

• Engage and negotiate with regulatory bodies.

• Stay informed about the regulatory landscape and evaluate the effects of changes.

⛳️ Requirements

• Bachelor’s degree with over 8 years of relevant regulatory experience.

• Proven experience as a Project Lead in the field of Regulatory Affairs.

• Familiarity with INDs/CTAs, NDAs/BLAs/MAAs.

• Proficient in lifecycle management.

• Experience in interactions with Health Authorities.

• Up-to-date knowledge of FDA perspectives, precedents, and guidelines.

• Outstanding verbal and written communication skills.

🏝️ Benefits

• Medical coverage.

• Dental coverage.

• Vision insurance.

• 401(k) retirement plan.

• Flexible Spending Account/Health Savings Account.

• Life insurance.

• Paid Time Off.

• Wellness program.