Regulatory Affairs Director jobs in New Jersey

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Sun Pharmaceutical Industries Ltd. (Sun Pharma) is the fourth largest specialty generic pharmaceutical company in the world with global revenues of over $ 4.5 billion US Dollars. Supported by more than 40 manufacturing facilities, we provide high-quality, affordable medicines, trusted by healthcare professionals and patients, to more than 100 countries across the globe including the United States. Sunology is a combination of Sun Values and Ideology and is the way of life at Sun Pharma.  Sunology is Humility.Integrity.Passion.Innovation.  It represents our promise to all stakeholders including patients, physicians, and employees.

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Sun Pharma Advanced Research Company (SPARC) is a pharmaceutical research and drug discovery organization that was formed in 2007 when SUN Pharmaceutical Industries Ltd separated out its active projects in drug discovery and innovation into a new company to provide the focus and the opportunity for growth of these projects which are now at different stages of preclinical and clinical development.

SPARC is seeking a Senior Director, Global Regulatory Affairs Strategist to join their team at the North American corporate headquarters in Princeton, NJ.

The position is to provide regulatory affairs strategic leadership for SPARC and supported Sun novel drug development programs.  Of each program this position supports, the individual will be responsible for developing and executing the overall regulatory strategy, which includes developing the registration pathway, interacting with regulatory agencies, and being responsible for all associated regulatory filings. 

The applicant should join SPARC to take the leadership position for clinical regulatory affairs strategy in a dynamic and rapidly growing novel drug discovery company.

Key responsibilities are to:

• Develop and execute novel drug regulatory strategy
• Insure SPARC’s development programs are compliant with ICH regulatory requirements and all local country regulatory requirements
• Strong project management skills and strong interpersonal skills to handle complex distributed programs
• Ability to author clear and concise regulatory documents with oversight of all documents for regulatory submissions and associated messaging
• Work closely with regulatory CMC lead and overall development team to insure overall regulatory strategy and regulatory CMC strategy are aligned
• Be the point of contact between the company and the regulatory agency – serve as the regulatory liaison for SPARC/SUN.

Technical Skills/Competencies (Software packages, experience with specific machines etc.)

• Thorough understanding of ICH and US CFR requirements and regulations.
• Regulatory document submissions authoring experience (INDs, IMPDs, NDAs, BLAs, briefing books)
• Regulatory agency direct interaction experience
• Strong communications skills

Education Requirements:

• Master’s degree in Chemistry, Biochemistry, Pharmacy, Biomedical Engineering, or Chemical Engineering is mandatory
• PhD or PharmD in above disciplines are preferred
• 10 years industry experience a must with RA novel drug development
• CMC and/or Botanical experience, RAC certification

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