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Nayeem Syed

General Manager – Global Regulatory Affairs & Business Development at Infill Life Sciences

Summary

Nayeem has more than 15 years of experience in various areas of pharmaceutical industry which includes Formulation Development, Quality, Compliance and Regulatory affairs. He is well experienced in submissions and getting approval of dossiers through regulatory authorities including USA and EU. He has submitted multiple scientific advice/meeting packages to health authorities (USA and EU) for IND and generic products and participated into face-to-face meetings. He was responsible for designing regulatory strategies for complex generics (LMWH, drug + device combination products, controlled release injectable). He has done due diligence / facility audits for both Indian and international companies (USA, UK, France, Canada, Belgium, China). Well experienced in facing facility inspections conducted by regulatory authorities (US FDA, MHRA, EDQM and other authorities). Has publication in national and international research journals. Attended (e.g. Culture of Quality) and was speaker in multiple training programs and conferences (e.g. GPhA USA).

Experience

General Manager – Regulatory Affairs and Business Development at Infill Life Sciences. (From July 2017 to till date).

Assistant General Manager – Regulatory Affairs at Wockhardt Ltd. (2004 – 2017).

Formulation & Development Scientist at Unichem Lab. (2003 -2004).

Education

Master of Pharmacy (Specialization: Pharmaceutics)

Bachelor of Pharmacy

General Course on Intellectual Property - WIPO

Diploma in Business Management

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Regd Office: B-2, Shrustivihar, Shreyanagar, Zambad Estate, Aurangabad, M.S, 431005, INDIA

+91-9552477712

snayeem@infill-life.com

www.infill-life.com

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Expertise

► Regulatory Affairs: Products Handled: Sterile Dosage Form (Liquid Injectable, Powder for Injection, Ophthalmic Products),

Peptide Products, Cephalosporin Products, Inhalation Products, Low Molecular Weight Heparin –Products. Medical Device (Autoinjector, Injector Pen, Dry Powder Inhalers), Combination Products (Drug + Device), Complex Generic Molecule, Oral Dosage Form.

Preparation, review, submission (CTD Submissions, eCTD Submissions) and approval of dossiers of drug products as per regulatory requirements (US FDA, EDQM, CANADA, MHRA and ROW). IND, ANDA, MAA, ANADA, PAS, CBE-30, CBE-0, Variations, Annual Report, Patent Amendments, OGD Communications, Deficiencies Responses (CMC, Labelling, Bioequivalence, Microbiology).

Expert in designing the sterility assurance package for Drug Products.

Review of Device Design History File, Risk management, and other data as per regulatory requirements.

Human Factor Studies/ Usability Testing for Medical Devices.

Monitor and assess the regulatory environment (product specific guidance’s, competitor products, etc.) to propose regulatory strategies or pathways (generic drug/ device, etc.).

Meetings with Regulatory Agencies:

o Well experienced in drafting meeting request, meeting packages, meeting presentations.

o Participated in multiple telephone meetings with EMA, MHRA, US FDA.

o Participated in 4 face-to-face meetings (CMC, Clinical, GMP Regulatory Meetings) at US FDA office USA.

o Pre-ANDA meetings.

► Quality & Compliance: Regulatory due diligence of regulatory applications (e.g. ANDAs).

Due diligence of sterilization facilities (Gamma sterilization, ETO sterilization etc.)

Facility audits of packaging material facilities (stoppers, CRC caps, ophthalmic bottles, caps, plugs etc.)

Due diligence / Facility audits of facilities located in India, USA, UK, Canada, China, France, Belgium, Italy.

Sterility Assurance: Sterility, Bacterial Endotoxin and Bioburden Testing. Media Fill Trials, Sterilization Process (Steam, Dry Heat, Gamma irradiation & ETO). Antimicrobial Efficacy Testing,

Evaluation of reconstitution, admixture studies and water loss studies

Evaluation of filter validation studies for drug product process.

Evaluation of packaging material sterilization process packages (e-beam, Gamma, ETO and other sterilization processes).

Evaluate manufacturing changes for compliance with appropriate change control systems/process and determine regulatory filing strategy.

Third Party Audit: Auditing of Vendors.

Faced multiple facility inspections by various regulatory authorities (US FDA, MHRA, & other authorities).

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Preparing responses for US FDA (483 Observations), EDQM, MHRA and other regulatory agency’s to the audit observations.

Pre-inspection assessment of Quality management systems.

Designing remediation pathway for compliance.

Awards/Honor

► Awarded as “Outstanding Performer” at Wockhardt Limited.

► Awarded as “Wock Star”.

► Among the 60 out of 8000 thousand employees selected and underwent rigorous management trainings (faculty from IIM, Dale Carnegie and other reputed Institutes) as a part of Wockhardt Champions program.

Events/Trainings Attended

► SEMINARS DELIVERED IN CONFERENCES & WORKSHOPS:

Key Facet in Pharmaceutical Research-2015

AICTE, New Delhi (IIPC Cell) Sponsored “Global Regulatory Requirements For Drugs And Pharmaceuticals”- 2012

National seminar on Drug Regulatory Affairs, Topic: QbR-A New Pharmaceutical Quality Assessment System- 2010

Guest lecture on “Regulatory Affairs” at Bhagwan College of Pharmacy

► MANAGEMENT TRAINING:

MS Project-Project Management, 2016.

Frontline Managers, January 2015.

Tough Talk, at Wockhardt, 2014.

Under 1year Extensive Management Training Programs (Trainers IIM), 2013 – 2014.

Training on High Impact Presentation DALE CARNEGIE, 2013.

Training on Communication Skills, 2012.

Training on Cross Culture Diversity and Effective Communication Skill London Institute of Corporate Training, India. October 2008.

► TECHNICAL TRAINING:

Culture of Quality (Trainer: Dr Ajaz Hussain, Ex US FDA) - 2015

GPhA Fall Conference, USA, October 2014.

Towards New Challenges in Global Regulatory Perspectives, IPA /EDQM / IPC, Technical Conference, 2010.

Microbiology Summit at Wockhardt Ltd, 2009, India.

Manufacturing Summit at Wockhardt Ltd, 2008, India.

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Primary Packaging and Drug Delivery Trends for Injectables - Reliability of Drug delivery Systems for Injectables, Packaging and Drug Delivery Workshop, Mumbai India. 7 November 2008.

GMP Regulations and Key Developments in Filtration, Separations and Purification Technologies for Pharmaceutical and Biotech Industries, Mr. Jerold Martin. Sr. VP Scientific Affairs, PALL Corporation, USA, Pune, 2008.

High Performance Liquid Chromatography” Dept of Chemical Technology, Dr. BAMU University, January 2007.

USP Annual Meeting, Mumbai, 2007.

National seminar on Advances in Pharmaceutical analysis at Y.B.C.C.P, Aurangabad, in 2007.

Seminar on fundamentals of filter validation and its regulatory implications, Millipore India, in 2006.

Workshop on Recent Trends in Pharmaceutical Technology, Y.B.C. C.P, Aurangabad, India in February 2006.

ISPE Conference on sterile dosage form in Mumbai, India, on 16th - 18th June 2005.

Seminars in 54th Indian Pharmaceutical Congress held at Pune India in December 2002.

Worked as volunteer Scientific Committee of 54th Indian Pharmaceutical Congress Pune in 2002.

Name:

Nayeem Syed

Signature:

Designation: General Manager – Global Regulatory Affairs & Business Development

Company:

Infill Life Sciences LLP