Director - Regulatory Affairs at Windsor

Job Description

SUN Pharma USA is a major global pharmaceutical company with annual sales of over US $2B.  SUN Pharma USA is ranked among the top pharmaceutical companies in the world and is a leader in the niche areas of Psychiatry, Neurology, Cardiology, Diabetes, and GI.  The 250,000 sq. ft. site in Cranbury, NJ is a strategic manufacturing site for Sun Pharma USA, US based operations.

The Director of Regulatory Affairs will work very closely with VP of Regulatory involving the activities related to ANDAs, amendments, supplements, ARs, FARs; interaction with Regulatory Authorities and agencies and joint interdepartmental work functions. In addition, will provide regulatory strategic input and compliance with FDA regulations, guidances, and applicable industry guidelines to the all the relevant departments.

ESSENTIAL JOB FUNCTIONS:

• Review outgoing submissions (ANDAs, amendments, supplements, annual reports) for compliance to FDA and corporate requirements.
• Review incoming FDA correspondence, determine target period for response to review letters, and recommend regulatory strategies. 
• Supervise and train Regulatory Department direct reports.
• Liaison between company and FDA/OGD for assigned products  
• Work very closely with the R&D to provide early guidance/support to ensure the completeness of filing and facilitate the ease of review at the FDA.
• Apply advanced oral and written communication skills, including document editing.
• Assist in compiling, reviewing and submitting Adverse Event and Field Alert Reports to the FDA
• Communicate effectively within department and with internal/external customers regarding submission-related activities.
• Participate in the development, review/revision, training and maintenance of SOPs .

Job Requirements

Master’s degree with 5+ years’ experience in drug regulatory submissions, preferably in generics or specialty pharmaceuticals or equivalent combination of education, training and experience. Knowledge and experience in the supervision and preparation of major regulatory submissions and supportive documents. Excellent knowledge of electronic submission guidance documents and regulations. Working knowledge of IND, NDA, ANDA, and post-approval submission requirements and guidelines. Detail oriented with strong communication, organizational and interpersonal skills. Ability to achieve critical timelines.
Country: USA, State: New Jersey, City: Windsor, Company: Sun Pharma USA.