Job Description

COMPANY SUMMARY:

DataRevive USA LLC is a regulatory consulting company helping pharmaceutical and biotech companies with their regulatory filing of US IND, BLA, and NDA during drug development. We specialize in both small molecule and biologic product regulatory affairs with specific expertise in CMC (chemistry, manufacturing, controls), nonclinical, clinical pharmacology and clinical areas. FOR MORE INFORMATION, GO TO WWW.DATA-REVIVE.COM.

POSITION SUMMARY:

We are seeking highly talented, small molecule CMC subject matter experts with considerable experience in their specific areas of expertise who can provide high-quality scientific, manufacturing, regulatory support and product/commercial development expertise to small molecule new and generic drug manufacturers.

ESSENTIAL DUTIES & RESPONSIBILITIES:

• Gap assessment for the submission dossier for IND/ANDA/NDA/505 (b)(2) filing
• Write the FDA meeting package and the regulatory dossier for the CMC part
• Serve as a CMC regulatory consultant for small molecule ANDA and IND filing
• Lead the CMC question discussions in the FDA meetings

MINIMUM QUALIFICATIONS:

• Extensive knowledge and experience with ANDA regulation in the US;
• Extensive knowledge and experience in organic synthesis or formulation;
• Highly experienced in the small molecule 505 (b)(1) and 505 (b)(2) regulatory application;
• Great written and communication skills;
• M.S. and above

PHYSICAL REQUIREMENTS

• · Prolonged periods of sitting at a desk and working on a computer.

WHAT WE OFFER YOU:

You’ll be a member of a phenomenal group of business professionals that have an innovative and team approach to success, based out of Rockville, MD. We guarantee that you will have tremendous learning opportunities and will be actively encouraged to creatively contribute. Our benefits are comprehensive and include medical, dental, vision, 401(k) matching, and generous flexible vacation and sick time allowances.

DataRevive USA LLC provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability or genetics. In addition to federal law requirements, DataRevive complies with applicable state and local laws governing nondiscrimination in employment in every location in which the company has facilities. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.

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