Nirvana Moodley nirvana.moodley@merck.com & | Self-motivated Regulatory Affairs professional 18+ years pharma experience , majority being in regulatory affairs, with expertise in:  Managing new application filings in US, EU, Canada, China, Japan and all international markets in capacity as Global Regulatory Lead and Regulatory Affairs international liaison.  Experience in various therapeutic areas: Oncology, HIV, Hepatitis C, Infectious diseases, Vaccines, General medicine.  Expert knowledge and application of FDA, ICH and WHO guidelines/regulations with high proficiency in supporting regulatory activities throughout a product’s lifecycle from Phase I through final deletion/divestiture including: BLA’s/NDA’s, IND’s, CTA’s, MAA’s, supplements, labelling requests, safety notifications, annual reports/PSUR’s/DSUR’s, response to agency questions, deletions/withdrawals, divestitures, recalls, business deals).  Developing innovative global regulatory strategies, leading cross-functional sub-teams and delivering on objectives/goals -cross functional collaboration and teamwork with internal and external partners. - Ability to effectively lead and motivate team members and direct reports.  Expertise in navigating complexity and working out process optimizations.

Nirvana Moodley

Self-motivated Regulatory Affairs professional 18+ years pharma experience , majority being in regulatory affairs, with expertise in:  Managing...

Carlsbad, Carlsbad, United States

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Nirvana Moodley’s Emails [email protected]

Nirvana Moodley’s Phone Numbers No phone number available.

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Nirvana Moodley’s Location Carlsbad, Carlsbad, United States

Nirvana Moodley’s Expertise Self-motivated Regulatory Affairs professional 18+ years pharma experience , majority being in regulatory affairs, with expertise in:  Managing new application filings in US, EU, Canada, China, Japan and all international markets in capacity as Global Regulatory Lead and Regulatory Affairs international liaison.  Experience in various therapeutic areas: Oncology, HIV, Hepatitis C, Infectious diseases, Vaccines, General medicine.  Expert knowledge and application of FDA, ICH and WHO guidelines/regulations with high proficiency in supporting regulatory activities throughout a product’s lifecycle from Phase I through final deletion/divestiture including: BLA’s/NDA’s, IND’s, CTA’s, MAA’s, supplements, labelling requests, safety notifications, annual reports/PSUR’s/DSUR’s, response to agency questions, deletions/withdrawals, divestitures, recalls, business deals).  Developing innovative global regulatory strategies, leading cross-functional sub-teams and delivering on objectives/goals -cross functional collaboration and teamwork with internal and external partners. - Ability to effectively lead and motivate team members and direct reports.  Expertise in navigating complexity and working out process optimizations.

Nirvana Moodley’s Current Industry Avidity Biosciences

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Work Experience

Avidity Biosciences

Senior Director, Global Regulatory Affairs

Mon Jan 01 2024 00:00:00 GMT+0000 (Coordinated Universal Time) — Present

Pfizer

Global Regulatory Affairs Lead

Thu Jul 01 2021 00:00:00 GMT+0000 (Coordinated Universal Time) — Mon Jan 01 2024 00:00:00 GMT+0000 (Coordinated Universal Time)

Merck

Director of Regulatory Affairs/Principal Scientist

Sun Dec 01 2019 00:00:00 GMT+0000 (Coordinated Universal Time) — Present

Merck

Associate Director Regulatory Affairs

Fri Apr 01 2016 00:00:00 GMT+0000 (Coordinated Universal Time) — Sun Dec 01 2019 00:00:00 GMT+0000 (Coordinated Universal Time)

Merck Sharp And Dohme

Senior Regulatory Affairs Pharmacist (Eastern and Southern Africa)

Fri Jun 01 2012 00:00:00 GMT+0000 (Coordinated Universal Time) — Tue Mar 01 2016 00:00:00 GMT+0000 (Coordinated Universal Time)

Sanofi

Regulatory Affairs Pharmacist

Thu Apr 01 2010 00:00:00 GMT+0000 (Coordinated Universal Time) — Fri Jun 01 2012 00:00:00 GMT+0000 (Coordinated Universal Time)

Aspen Pharma

Regulatory Affairs Pharmacist

Fri Aug 01 2008 00:00:00 GMT+0000 (Coordinated Universal Time) — Thu Apr 01 2010 00:00:00 GMT+0000 (Coordinated Universal Time)

Skills

Languages

FAQ About Nirvana Moodley

Nirvana Moodley is located at
Carlsbad, Carlsbad, United States

Nirvana Moodley is a
Self-motivated Regulatory Affairs professional 18+ years pharma experience , majority being in regulatory affairs, with expertise in:  Managing new application filings in US, EU, Canada, China, Japan and all international markets in capacity as Global Regulatory Lead and Regulatory Affairs international liaison.  Experience in various therapeutic areas: Oncology, HIV, Hepatitis C, Infectious diseases, Vaccines, General medicine.  Expert knowledge and application of FDA, ICH and WHO guidelines/regulations with high proficiency in supporting regulatory activities throughout a product’s lifecycle from Phase I through final deletion/divestiture including: BLA’s/NDA’s, IND’s, CTA’s, MAA’s, supplements, labelling requests, safety notifications, annual reports/PSUR’s/DSUR’s, response to agency questions, deletions/withdrawals, divestitures, recalls, business deals).  Developing innovative global regulatory strategies, leading cross-functional sub-teams and delivering on objectives/goals -cross functional collaboration and teamwork with internal and external partners. - Ability to effectively lead and motivate team members and direct reports.  Expertise in navigating complexity and working out process optimizations. Avidity Biosciences

Nirvana Moodley currently works in the
Avidity Biosciences

Nirvana Moodley specializes in
Self-motivated Regulatory Affairs professional 18+ years pharma experience , majority being in regulatory affairs, with expertise in:  Managing new application filings in US, EU, Canada, China, Japan and all international markets in capacity as Global Regulatory Lead and Regulatory Affairs international liaison.  Experience in various therapeutic areas: Oncology, HIV, Hepatitis C, Infectious diseases, Vaccines, General medicine.  Expert knowledge and application of FDA, ICH and WHO guidelines/regulations with high proficiency in supporting regulatory activities throughout a product’s lifecycle from Phase I through final deletion/divestiture including: BLA’s/NDA’s, IND’s, CTA’s, MAA’s, supplements, labelling requests, safety notifications, annual reports/PSUR’s/DSUR’s, response to agency questions, deletions/withdrawals, divestitures, recalls, business deals).  Developing innovative global regulatory strategies, leading cross-functional sub-teams and delivering on objectives/goals -cross functional collaboration and teamwork with internal and external partners. - Ability to effectively lead and motivate team members and direct reports.  Expertise in navigating complexity and working out process optimizations.

Nirvana Moodley speaks the following languages:
No languages available.

Nirvana Moodley has prior experience in the following industries:
Pfizer , Merck , Merck Sharp And Dohme , Sanofi , Aspen Pharma

Nirvana Moodley has the following professional experience:
Avidity Biosciences , Pfizer , Merck , Merck , Merck Sharp And Dohme , Sanofi , Aspen Pharma .