purnima Mungalachetty
MessageRoles available for:
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Fractional
-
Consulting
-
Contract
-
Interim
-
Tewksbury, Massachusetts, United States
purnima Mungalachetty
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Roles available for:
-
Fractional
-
Consulting
-
Contract
-
Interim
-
Tewksbury, Massachusetts, United States
Experience
Fractional role
Strengths in this role: Strategic leadership in global regulatory submissions (IND, BLA, NDA, IMPD). Expert in FDA, EMA, MHRA, and Health Canada engagement and negotiations Proven ability to lead regulatory strategy for gene therapies, biologics, and RNA therapeutics. Skilled in compliance implementation including SOPs, eTMF, and Veeva RIM Effective cross-functional team leadership and vendor management Agile in contract, consulting, and fractional roles with rapid integration Strong project management, budgeting,
Industry Group: Health
Industry: Biotechnology
Years of experience: 20 years
Industry Group: Health
Industry: Pharmaceuticals
Years of experience: 20 years
Company name: DiaMedica
Company size: 29 employees
Role in this company: Primary point of contact to FDA, EMA, Health Canada Regulatory Strategy , Clinical and CMC
Company name: MeiraGTX
Company size: 200 employees
Role in this company: • Primary point of contact to FDA and HC. Led all aspects of clinical and CMC related health authority (HA) submissions for AAV platform gene therapies for RPGR, Xerostomia and GAD Parkinsons programs. • Successfully led late stage RPGR asset transfer to Jannsen. • I
Company name: Boston Pharmaceuticals
Company size: 40 employees
Role in this company: • Developed and executed global regulatory strategies for biologics and small molecules, submitted BOS-421 IND in first 3.5 months of onboarding. •
