Mangesh Sahane
Mumbai
Summary
Seasoned Regulatory Affairs Leader specializing in global submissions and lifecycle management. Develops submission strategies and ensures compliance while enhancing approval rates through team training and quality assurance. Expertise in CMC documentation and risk assessment supports successful outcomes in complex regulatory environments.
Overview
28
28
years of professional experience
Work History
Vice President, Regulatory Affairs, Pharmacovigilance Packaging Development
Unichem Laboratories Limited
Mumbai
01.2017 - Current
- Global Regulatory Submissions and Lifecycle Management for Formulations and APIs.
- Submission strategy for generic products in ANDA, EU Dossiers, all Emerging Markets.
- Developed submission strategy for drug master files globally and CEPs.
- Tracked submissions for formulations and APIs through all development stages to ensure timely final submissions.
- Training team for high quality submission to minimize the deficiencies and achieve approval in optimum time.
- Reviewed deficiencies and formulated responses to achieve satisfactory closure.
- Review of core documents, development reports, justification of specification, KSM documents to ensure high quality submission.
- Define and execute the regulatory strategy for regulatory submissions for cost reduction projects.
- Life cycle management of API and formulation submissions through supplements, amendments, annual reports for the approved ANDAs, EU MAs, CEP and all Drug Master Files.
- Oversaw packaging development activities, including artwork development, specification maintenance, and test method creation for packaging materials.
- Oversee the compliance for Global Pharmacovigilance Activities, monitoring CROs, submission of aggregate reports, medical enquiries, quality complaints.
- Since April 2024 took additional charge to lead the global regulatory submission and life cycle management for Ipca Laboratories Limited.
Head Regulatory Affairs
Indoco Remedies
Navi Mumbai
10.2012 - 01.2017
- Define and execute the regulatory strategy for regulatory submissions for cost reductions projects.
- Submission strategy for generic products (Solid Orals, Parenteral and Ophthalmic formulations) in ANDA, EU Dossiers, all Emerging Markets.
- Submission strategy for drug master files globally and CEPs.
- Global Regulatory Submissions and Lifecycle Management for Formulations and APIs.
- Tracked submissions for formulations and APIs through various development stages to ensure timely final submissions.
- Training team for high quality submission to minimize the deficiencies and achieve approval in optimum time.
- Reviewed deficiencies and formulated responses to achieve satisfactory closure.
- Review of core documents, development reports, justification of specification, KSM documents to ensure high quality submission.
- Life cycle management of API and formulation submissions through supplements, amendments, annual reports for the approved ANDAs, EU MAs, CEP and all Drug Master Files.
Senior Manager, Regulatory Affairs
USV Limited
Mumbai
10.2006 - 10.2012
- Led regulatory activities for US and EU markets, ensuring compliance with relevant guidelines and standards.
- Coordinated timely submission of ANDAs for Solid Orals, Parenterals, and Ophthalmic products, facilitating market access.
- Over 30 ANDAs filed in eCTD format using Electronic Submission Gateway.
- Sound experience in writing responses to CMC deficiencies and submission of labeling and bioequivalence amendments.
- Managing work, work allocation and supporting subordinates for effective submissions and responses.
- Studied and applied ICH guidelines on Quality to ensure compliance in product development.
- Thorough understanding of 21 CFR Part 314, 210 and 211 and current FDA guidance.
- Compiled Quality Overall Summary/QbR.
- Submissions of supplements (CBE, CBE30 and PAS) and annual reports for the approved ANDAs.
- Complete understanding in defining of specifications for finished product, actives, excipients as per the current recommendations of Q3A, Q3B, Q3C, Q6A, Genotoxic impurities and EMEA guidance on Metal Catalyst.
- Review of analytical method validations to confirm compliance to ICH Q2A.
- Review of Process Validations, Cleaning Validations and review of Change controls.
- Submission of Structure Product Labeling for drug listing in SPLR4 format.
- Managed applications for Decentralised, Mutual Recognition, and National Procedures for various Solid Orals, Parenterals, and Ophthalmic products.
- Review and submission of Day 70, Day 100, Day 120 and Day 195 assessment responses.
- Timely submission of Post Approval Variations (Type IA, IB and Type II).
- Performed annual updates and renewals of regulatory licenses to maintain compliance.
- Review of outsourced Drug Master Files.
- Well versed with EMEA guidelines for Human Medicines.
- Submitted INDs for two new NCEs.
Executive Regulatory Affairs
Lupin Ltd.
06.2005 - 10.2006
- Prepared and submitted pre-qualification dossier to WHO for anti-tuberculosis drugs, facilitating access to essential treatments.
- Prepared and submitted dossiers for solid orals to semi-regulated markets including South Africa, Taiwan, and South Korea, expanding market reach.
- Prepared and submitted dossiers for ethical formulations including tablets, capsules, aerosols, and topical preparations across Middle East, Africa, and South East Asia, ensuring regulatory compliance.
Executive Regulatory Affairs
Cipla Ltd.
11.1999 - 05.2005
- Registered various ethical formulations including tablets, capsules, aerosols, and more in semi-regulated countries such as the Middle East, Africa, Asia, and Southeast Asia.
- Prepared applications and coordinated with local FDA to obtain certificates, including the Certificate of Pharmaceutical Product and GMP certificates, for registration dossiers and tenders.
- Executed pre-inspections of manufacturing facilities, ensuring readiness for WHO-GMP audits.
- Coordinated and submitted technology transfer documents for regulatory approval in Iran, Oman, Algeria, and Bangladesh.
- Developed and submitted tender documents for MSF and UNICEF across Zambia, Senegal, Togo, Mali, Rwanda, Burundi, and Kenya, ensuring compliance with local regulations.
Junior Executive
Charak Pharmaceuticals Pvt. Ltd.
07.1998 - 10.1999
- Managed manufacturing process of tablets, including granulation, compression, and coatings.
- Prepared daily, weekly, and monthly production planning and performance statements to track progress.
- Worked with Product Development Department for development of formulations viz, tablets, capsules and liquid orals.
- Coordinated with Q.C. department to release raw materials for manufacturing.
- To receive the raw materials/ packing materials and prepare the GRN and send to Q.C. dept.
- Maintained minimum inventory levels to ensure uninterrupted production schedule.
- Maintained PLA, RG1, and Modvat records accurately.
Education
B.Sc. - Chemistry
Mumbai University
Mumbai01-1998
H.S.C. -
Mumbai Board
Mumbai01-1995
S.S.C. -
Mumbai Board
Mumbai01-1993
Post Graduate Diploma - Pharma Regulatory Affairs
Bioinformatics Institute of India
NoidaSkills
- Regulatory submissions
- Regulatory strategy
- Submission strategy
- Pharmacovigilance compliance
- Compliance auditing
- Regulatory labeling
- Labeling compliance
- CMC documentation
- Risk assessment
- Quality assurance
- Lifecycle management
- Drug master files
Seminars And Presentations
Attended various seminars on cGMP, Process Validations, Cleaning Validations, eCTD Submissions, Extractables and Leachables arranged by ISPE, IDMA, CIBA and USP.
Languages
- English
- Hindi
- Marathi
Personal Information
- Date of Birth: 09/13/77
- Gender: Male
- Nationality: Indian
- Marital Status: Married
- Religion: Hindu
Career Aspiration
I've started my professional career in year 1998 as Production Executive with herbal based formulation company, Charak Pharmaceuticals. In the late 1999 joined Cipla with Regulatory Affairs. I worked for about 6 years for registration and life cycle management of dossiers in various Middle East and Southeast Asian countries. I worked with Lupin Pharmaceuticals about a year and half where I took the assignments for MCC, GCC and WHO pre-qualification dossiers. I worked with USV for about 6 years to manage ANDA and EU submissions and their life cycle management. Worked with Indoco Remedies Ltd. for global regulatory submissions for solid oral, sterile formulations, APIs and life cycle management. Currently working as Vice President Regulatory Affairs with Unichem Laboratories Limited and leading team for global regulatory submission which formulation and API. Since April 2024 leading global regulatory submission took additional charge to lead global submission for Ipca Laboratories Limited for formulation and API. I aspired to continue to work with a progressive pharmaceutical organization and work towards achieving goals and progress of the organization while propelling my carrier to a leadership position.
Additional Qualification
- Diploma in computer applications (Windows XP/98/2000, MS Office XP/2000, Internet & emails).
- Familiar with the Windows 2007, Office 2010, Internet & secure emails.
- Thorough knowledge of server based applications in Windows 2000/NT server, data management software such as Edoc & Laserfische.
- Thorough knowledge of eCTD Manager, 21 CFR compliant software such as Extedo.
- Through knowledge of 21 CFR compliant Structure Product Labeling software provided by Take Solution.
- Passed typing exam @ 30 w.p.m. with first class in March 1993.
Languages
English
Proficient (C2)
C2
Hindi
Proficient (C2)
C2
Marathi
Proficient (C2)
C2
Accomplishments
- Chairman's Award in 2019
Timeline
Vice President, Regulatory Affairs, Pharmacovigilance Packaging Development
Unichem Laboratories Limited
01.2017 - Current
Head Regulatory Affairs
Indoco Remedies
10.2012 - 01.2017
Senior Manager, Regulatory Affairs
USV Limited
10.2006 - 10.2012
Executive Regulatory Affairs
Lupin Ltd.
06.2005 - 10.2006
Executive Regulatory Affairs
Cipla Ltd.
11.1999 - 05.2005
Junior Executive
Charak Pharmaceuticals Pvt. Ltd.
07.1998 - 10.1999
B.Sc. - Chemistry
Mumbai University
H.S.C. -
Mumbai Board
S.S.C. -
Mumbai Board
Post Graduate Diploma - Pharma Regulatory Affairs
Bioinformatics Institute of India