Vice President, Head Of Regulatory Affairs
Current
Sep 2024 - Present
AeroLeads people directory · profile
Janaki (Jana) Subramanyam Email & Phone Number
Vice President, Head of Regulatory Affairs at Climb Bio, Inc.
at
Climb Bio
1 work email found
@abcuro.com
2 phones found area 978 and 508
LinkedIn matched
✓ Verified May 2026
4 data sources
Profile completeness 100%
Current company
Role
Vice President, Head of Regulatory Affairs at Climb Bio, Inc.
Location
Wilmington, North Carolina, United States
Who is Janaki (Jana) Subramanyam? Overview
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Quick answer
Janaki (Jana) Subramanyam is listed as Vice President, Head of Regulatory Affairs at Climb Bio, Inc. at Climb Bio, based in Wilmington, North Carolina, United States. AeroLeads shows a work email signal at abcuro.com, phone signal with area code 978, 508, and a matched LinkedIn profile for Janaki (Jana) Subramanyam.
Janaki (Jana) Subramanyam previously worked as Vice President, Head of Regulatory Affairs at Climb Bio and Vice President, Head of Regulatory Affairs at Climb Bio. Janaki (Jana) Subramanyam holds M.Sc, Microbiology & Immunology from Ohio University.
Company email context
Email format at Climb Bio
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{first_initial}{last}@abcuro.com
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AeroLeads found 1 current-domain work email signal for Janaki (Jana) Subramanyam. Compare company email patterns before reaching out.
Profile bio
About Janaki (Jana) Subramanyam
Regulatory Affairs professional with 25+ years of strategic leadership experience with FDA, EMA and Health Canada regulations in small to mid-size biotechnology companies. Proven history of successful leadership of teams in various therapeutic areas (drugs, biologics & medical imaging products) including multiple approvals and successful negotiations related to FDA expedited programs in rare diseases. Hands-on leadership experience in drug development with a breadth of experience in nonclinical, manufacturing and quality, as well as clinical development, pharmacology, regulatory development and post marketing advertising and promotional expertise. Member of the Management Team participating in all aspects of the Company's business. Built a small, effective regulatory team to support activities. Strengths include providing strategic input to cross functional teams, management of departmental operations, project management related to submission activities, as well as leading and mentoring multi-functional teams. Exceptionally organized and articulate; possessing strong interpersonal skills and a flexible work style to effectively collaborate with individuals at all levels in a matrix environment.
Listed skills include Regulatory Affairs, Clinical Development, Fda, Pharmaceutical Industry, and 14 others.
Current workplace
Janaki (Jana) Subramanyam's current company
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16 roles · 39 years
Janaki (Jana) Subramanyam work experience
A career timeline built from the work history available for this profile.
Vice President, Head Of Regulatory Affairs
Sep 2024 - Oct 2024
Vice President, Head Of Regulatory Affairs
Responsible for providing strategic oversight and implementing regulatory strategy for Abcuro’s lead product candidate Ulviprubart (ABC008) for autoimmune disorders and rare cancers, including Inclusion Body Myositis (IBM), T Cell Large Granular Lymphocytic Leukemia (T-LGLL) and T-Cell and NK-Cell Lymphomas (TNK). Ulviprubart is a humanized, afucosylated.
May 2022 - Aug 2024
Executive Director, Head Of Regulatory Affairs
Responsible for providing strategic oversight and implementing regulatory strategy for Allena’s oral enzyme development products: Reloxaliase (ALLN-177) an oxalate decarboxylase for reduction of urinary oxalate in patients with enteric hyperoxaluria and ALLN-346 (engineered urate oxidase) for the reduction of hyperuricemia in gout and advanced chronic.
May 2016 - May 2022
Senior Director, Regulatory Affairs
Strategic oversight for regulatory and clinical development of the Company’s lead agent (Encenicline) for cognition in Schizophrenia and Alzheimers Disease & histone deacetylase (HDAC) inhibitor for fronto-temporal dementia (FTD). Primary regulatory lead for US FDA (Division of Psychiatry Products & Division of Neurology) on key matters during clinical.
Dec 2014 - May 2016
Senior Director, Global Regulatory Affairs
Provided strategic oversight for regulatory, manufacturing and clinical development for the Company’s lead cardiac nuclear imaging agent (flurpiridaz). Primary regulatory consultant and external spokesperson on key matters for all development products with regulatory agencies and Company management. Member of the Senior Leadership Team with management.
Dec 2012 - Feb 2014
Director, Global Regulatory Affairs
Leadership role for all regulatory related activities of AMAG’s approved products (Feraheme® & GastroMark®) including management of the department (3 Regulatory Managers & 1 Administrative Assistant). Strategic development and operational responsibility for all submissions (IND, CTA, NDA, MAA, NDS), clinical & manufacturing development for therapeutic and.
Dec 2006 - Nov 2012
Manager, Regulatory Affairs
Provided strategic oversight of regulatory & clinical development for a biologic product (tri-functional monoclonal antibody) in Ovarian Cancer (Division of Oncology Products in CDER). Reviewed all IND related information; Preclinical, CMC & Clinical documentation to ensure quality & completeness prior to submission. Developed appropriate departmental.
Jul 2005 - Dec 2006
Associate Director Regulatory Affairs
Able Laboratories
Provided strategic oversight of regulatory & clinical development, including regulatory intelligence for a biologic & weight loss drug in the US and India.
Jan 2005 - Jun 2005
Manager Regulatory Affairs
The Gillete Company
Managed operational activities including coordination, planning & execution of submissions for drugs, devices & OTC products to regulatory agencies in US & Canada. Managed staff (1 Regulatory Associate).
Feb 2004 - Jan 2005
Manager Regulatory Affairs
Control Delivery Systems
Provided regulatory & project management support to project teams for planning, review, editing and compilation of summaries, study reports and CMC documentation for IND. Managed and mentored staff (2 Regulatory Associates).
Jun 2003 - Jun 2003
Manager, Regulatory Affairs
Alkermes
Provided regulatory & project management support for Alkermes proprietary combination respiratory products (CDER Division of Pulmonary, Allergy & Rheumatology Products) for AIR Division. Managed staff (1 Regulatory Associate).
May 2002 - Aug 2002
Manager, Regulatory Affairs
Managed, mentored staff (5 Regulatory Associates) and coordinated projects for all North American offices. Ensured adherence to timeline, quality and budget on a wide array of regulatory projects including clinical trial support, electronic submissions and US Agent responsibilities for foreign manufacturers. Primary contact on projects with CDER’s.
May 1997 - May 2002
Regulatory Affairs Associate, Cmc
Genetics Institute
Served as the Regulatory contact for Baxter Healthcare. Prepared and reviewed CMC section for IND Annual Reports and IDE Progress Reports. Provided regulatory CMC support for all activities related to the manufacture of Phase III and approved products.
1995 - 1997
~2 yrs
Senior Associate Scientist
Genetics Institute
1992 - 1995
~3 yrs
Scientist A & Scientist B
Sandoz Research Institute
1987 - 1992
~5 yrs
2 education records
Janaki (Jana) Subramanyam education
M.Sc, Microbiology & Immunology
Ohio University
Bachelor Of Science (B.Sc.), Microbiology & Biochemistry
St. Xavier'S College
FAQ
Frequently asked questions about Janaki (Jana) Subramanyam
Quick answers generated from the profile data available on this page.
What company does Janaki (Jana) Subramanyam work for?
Janaki (Jana) Subramanyam works for Climb Bio.
What is Janaki (Jana) Subramanyam's role at Climb Bio?
Janaki (Jana) Subramanyam is listed as Vice President, Head of Regulatory Affairs at Climb Bio, Inc. at Climb Bio.
What is Janaki (Jana) Subramanyam's email address?
AeroLeads has found 1 work email signal at @abcuro.com for Janaki (Jana) Subramanyam at Climb Bio.
What is Janaki (Jana) Subramanyam's phone number?
AeroLeads has found 2 phone signal(s) with area code 978, 508 for Janaki (Jana) Subramanyam at Climb Bio.
Where is Janaki (Jana) Subramanyam based?
Janaki (Jana) Subramanyam is based in Wilmington, North Carolina, United States while working with Climb Bio.
What companies has Janaki (Jana) Subramanyam worked for?
Janaki (Jana) Subramanyam has worked for Climb Bio, Abcuro, Inc, Allena Pharmaceuticals, Inc., Forum Pharmaceuticals (Formerly Envivo Pharmaceuticals), and Lantheus Medical Imaging.
How can I contact Janaki (Jana) Subramanyam?
You can use AeroLeads to view verified contact signals for Janaki (Jana) Subramanyam at Climb Bio, including work email, phone, and LinkedIn data when available.
What schools did Janaki (Jana) Subramanyam attend?
Janaki (Jana) Subramanyam holds M.Sc, Microbiology & Immunology from Ohio University.
What skills is Janaki (Jana) Subramanyam known for?
Janaki (Jana) Subramanyam is listed with skills including Regulatory Affairs, Clinical Development, Fda, Pharmaceutical Industry, Clinical Trials, Pharmacovigilance, Biotechnology, and Oncology.
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