Associate Director/Director Regulatory Affairs

Company Overview:  

 Prinston Pharmaceutical, Inc. is a fully integrated, mid-sized pharmaceutical company focused on the development, manufacturing, and commercialization of high-quality, affordable generic medicines in the United States. Building on a strong foundation of cGMP-compliant operations, we combine the reliability of an established platform with the agility and ambition of a growing organization. Our expanding portfolio and pipeline—particularly in complex generics—reflect a commitment to bringing cost-effective therapies to market with speed, quality, and precision. As we continue to scale, we operate with a lean, execution-driven model where experienced professionals have the opportunity to influence strategy, drive decisions, and make a measurable impact. We are committed to maintaining the highest standards of quality, compliance, and integrity while advancing access to essential medicines.

Position Overview: 

Prinston Pharmaceutical Inc. is seeking a high-caliber, strategic Regulatory Affairs Director to lead our complex portfolio, including Biosimilars (351(k)) and 505(b)(2) innovative products. The Director will serve as the primary architect of regulatory strategy, navigating the evolving FDA landscape to ensure successful product approvals and lifecycle management. 

Key Responsibilities: 

• Strategic Leadership: Lead the development of innovative regulatory strategies for biosimilars, aligning with corporate goals and navigating the 351(k) pathway requirements, as well as complex regulatory strategies for 505(b)(2) products. 
• Submission Oversight: Provide executive-level oversight and final review for all eCTD submissions, ensuring the technical and scientific integrity of Biosimilar and 505(b)(2) filings, amendments, and supplements. 
• FDA Liaison: Serve as the primary, high-level liaison with the FDA; lead formal negotiations and represent the company in all strategic meetings regarding development and filing pathways. 
• Quality & Compliance Leadership: Direct the critical review of complex source documents (clinical, analytical, and CMC) to ensure they exceed the highest standards of technical adequacy and align with current cGMP and Agency guidance. 
• Regulatory Intelligence: Proactively monitor, interpret, and communicate the impact of emerging regulations, guidance (including BPCI Act updates), and industry trends on the company's long-term portfolio. 
• Cross-Functional Partnership: Act as a key strategic partner to manufacturing, clinical, and operation teams, providing high-level regulatory guidance to drive project timelines. 

Qualifications: 

• Master’s degree or PhD/PharmD in a relevant scientific field, with extensive experience in the pharmaceutical industry. 
• Must have significant regulatory experience in biosimilars (351(k)); deep experience with 505(b)(2) or complex innovative products is required. 
• At least 10-12 years of progressive experience in pharmaceutical regulatory affairs; expert knowledge of cGMP is required. 
• Proven track record of successful FDA interactions and leadership of complex regulatory submissions. 
• Excellent executive-level communication, team leadership, and strategic decision-making skills. 

Compensation & Benefits: 

• Base salary: $150,000 – $200,000   
• With bonus  

Location: NJ

Benefits: 

• 401(k) 
• Health insurance  
• Dental insurance 
• Paid time off  
• Vision insurance 

Job Type: Full-time