Regulatory Affairs Director

6 days ago


Woburn, Massachusetts, United States Azurity Pharmaceuticals Full time
Job Summary:

We are seeking a highly skilled Regulatory Affairs Director to join our team at Azurity Pharmaceuticals. As a key member of our commercial regulatory strategy team, you will be responsible for providing leadership and guidance on promotional materials, advising internal teams and management on regulations, and performing regulatory review of advertising and promotional materials.

Key Responsibilities:

• Provide commercial regulatory strategy and leadership for promotional materials
• Advise internal teams and management on regulations, guidance, and industry best practices related to product labeling and advertising/promotional components
• Perform regulatory review of advertising and promotional materials, as required
• Lead cross-functional teams to facilitate discussions regarding regulatory labeling submission strategies, required documentation, and regulatory risks
• Lead the MLR review committee for advertising and promotional components
• Develop and maintain knowledge of submission process for promotional components to FDA's Office of Prescription Drug Promotion (OPDP)
• Collaborate with third-party vendors to ensure compliance with regulatory requirements
• Create and revise SOPs and Work Instructions as applicable, to ensure high-performing regulatory operations and effective review processes
• Continuously monitor the regulatory environment for new regulations, guidance, and enforcement
• Recruit, develop, and act as an advisor and coach to direct reports and junior members of the regulatory team

Requirements:

• Bachelor's degree in Life Science or other related discipline
• At least 10 years of experience in Regulatory Affairs, with direct experience in Labeling and Advertising/Promotional review
• Strong expertise and knowledge of Advertising/Promotional regulations and guidance
• Excellent organizational, interpersonal, verbal, and written communication skills, strong grammar, and proofreading skills
• Ability to rapidly adapt to changing environment and circumstances requiring flexibility, tolerance, and great sense of urgency while ensuring that all cGMP and regulatory requirements are met

What We Offer:

• Competitive salary and benefits package
• Opportunity to work with a dynamic and growing company
• Collaborative and supportive work environment
• Professional development and growth opportunities

How to Apply:

If you are a motivated and experienced Regulatory Affairs professional looking for a new challenge, please submit your resume and cover letter to [insert contact information].

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