Sharon Dsouza
Director, Regulatory Affairs | CMC
- Role
- Director of Regulatory Affairs, Cmc, Emerging Markets at Althera
- Location
- Mumbai, MH, IN
- LinkedIn followers
- 500 followers
About Sharon Dsouza
I am a regulatory Affairs professional with hands on experience since 2011 in the Pharmaceutical industry, being involved in International regulatory submission, deficiency response, Life cycle management, supporting In-license, Out-license business opportunities for Emerging markets, namely Asia, Africa, Middle East, Russia CIS and LatAm.Experienced in managing end-to-end activities i.e. regulatory support from product development stage, strategizing regulatory filings, technical documentation review, guiding team members to make effective submissions of New Fixed dose combination products, New drug product application, Generic applications, Post approval changes with the aim to significantly reduce deficiencies and obtain swift approvals.
Experience
Director of Regulatory Affairs, Cmc, Emerging Markets
Mar 2025 — Present · Mumbai, IN
Spearhead Regulatory Affairs initiatives for line extensions, new product registrations and new developments across emerging markets. Develop and implement regulatory strategies, overseeing product submission planning and deficiency management. Stay abreast of evolving regulatory guidelines, maintaining a comprehensive regulatory intelligence database for informed business decisions. Collaborate with regulatory consultants and business partners to drive regulatory submissions and approvals. Provide critical support to internal teams for successful product launches. Facilitate seamless communication and co-ordination with health authorities, ensuring regulatory compliance and approvals.
Education
University of Mumbai
M.Sc
Institute of Pharmaceutical Management
Post graduate Diploma
2011 — 2012
Find verified contacts for anyone on LinkedIn
Unifers gives sales teams verified emails and direct dials, enriched profiles, and outreach that lands in the inbox.
Free plan included · No credit card required
This profile is compiled from publicly available professional sources. Unifers is not affiliated with or endorsed by LinkedIn. Request removal of this profile.