Swapnil Jain
Pune
Summary
I am experienced regulatory professional (17+ years) with a proven track record of working on regulatory certifications/approvals of chemicals, excipients, medical devices, in-vitro diagnostic devices, drug-device combination products, drug products, and biological products worldwide, including the United States, the European Union, and Asia Pacific. I do have end-to-end experience ranging from establishing regulatory needs in the early stages of product development to gaining regulatory clearance and managing life cycle in the post-approval phase. Ensure timely and correct submission of registration applications in accordance with the company's strategic goals. Seeking suitable positions in reputed organizations.
Overview
17
17
years of professional experience
Work History
Manager-Regulatory affairs
Company
12.2021 - Current
- Managing the regulatory approvals of the company's product line (Chemicals, reagents, In-Vitro Diagnostic kits; IVD instruments/analyzers; Research use only products) for South Asia (Afghanistan, Bangladesh, Bhutan, India, Maldives, Nepal, Pakistan, and Sri Lanka) and Europe market.
- Leading team of manufacturing site and regional regulatory professionals.
- Representing company at India level and managing the regulatory approvals/clearances from various regulatory agencies in India including the DBT, DSIR, MoEF, DAHD, BIS, DGFT, MoHFW, ICMR, FSSAI and CDSCO.
- Defining strategy for local performance evaluation studies.
- ISO 13485, CE, REACH certification.
- Make-in-India for In-Vitro Diagnostic kits.
- Acting as Authorized Agent in India for IVD Import License (Form MD 14, 15).
- Obtaining IVD Import License (Form MD 14, 15), Test License to import In-vitro diagnostics, Permission to conduct Clinical Performance Evaluation (Form MD 24, 25), Free Sale Certificate, Registration of chemicals as per REACH legislation.
- Responsible for Legal Metrology - Model Approval, MSDS - Publication.
- Responsible for Wholesale License Form 20B Approval.
- Point of Contact for Regional commercial team for business support securing necessary Regulatory approvals.
Senior Manager-Regulatory affairs
Company
12.2018 - 12.2021
- Managing the regulatory approvals of the company's product line (Medical devices including imaging equipment).
- Regulatory life cycle management for both locally manufactured and imported medical devices.
- Preparation and submission of technical dossier to regulatory authorities e.g. the FDA, (US PMAs, US IDEs, US 510(k), DE NOVO 510(k) and other relevant submissions).
- Creating and maintaining general safety and performance requirements checklists, CE technical files, and declarations of conformity for all products bearing the CE Marking.
Manager-Regulatory affairs
Company
09.2012 - 11.2018
- Acted as regulatory lead responsible for preparation, registration, and maintenance of CE Technical Files (TF), Device Master Records (DMR) and CE Design History Files (DHF) for conformity assessment for medical devices (MDD 93/42/EEC, ISO 13485, FDA).
- Handled various drug delivery and biotech products including pen injectors (reusable and disposable), insulin syringes, auto-injectors, inhalation products, nebulizers, nasal sprays etc.
- Development and submission of regulatory dossier (including responses, briefing packages, MAA's, NDAs, INDs, ANDAs or other regulatory dossiers).
- Prepared of pre-ANDA briefing packages, scientific advice briefing packages for discussion with regulatory agencies.
- Attended telephonic and face-to-face meetings with regulatory agencies including USFDA and MHRA.
- Managed Regulatory life cycle for licensed products (e.g. preparations, coordination of submission of variations, annual reports, post-authorization measures).
- Monitored external device development partners/device manufacturers of device constituent part of combination products to ensure regulatory compliance.
- Supported corporate quality & manufacturing teams during inspection of drug delivery devices as per ISO 13485 and 21 CFR part 4.
Assistant Manager-Regulatory affairs
Company
08.2011 - 08.2012
- Acted as member of the regulatory team responsible for regulatory submissions in the international markets.
- Handled various topical products including creams and ointment.
Executive-Regulatory affairs
Company
05.2008 - 08.2011
- Acted as member of the regulatory team responsible for regulatory submissions (ANDAs, INDs, CTAs) in the USA and Europe; Post-approval changes (CBE-30, PAS), Annual report filings; Deficiency response to agency queries.
- Handled various drug delivery and injectable products including dry powder inhalers, metered dose inhalers, nebulizers, nasal sprays and solution injectable.
Education
Doctorate - Pharmacy
Marathwada University
INDIA01.2016
Master's - pharmacy
The M.S. University of Baroda
INDIA01.2008
Bachelor's - pharmacy
Pune University
INDIA01.2006
Skills
- CE certification
- EU MDR 2017/745
- MDD 93/42/EEC
- RoHS 2011/65/EU
- RED 2014/53/EU
- 21 CFR Part 820
- Article 117 Notified body opinion
- IEC 60601-1
- IEC 60601-1-2
- IEC 60601-1-3
- IEC 60601-2-43
- IEC 60601-2-54
- IEC 61000-4-x
- ISO 14971
- ISO 13485
- Leadership
- Negotiations
- Communication
- Interpersonal skills
- MDSAP
- Notified body audit
- Brazil INMETRO
- KGMP
- CDSCO
- AERB
Accomplishments
- Received University Gold Medals for outstanding academic performance in the Bachelor's and Master of Pharmacy programs.
- Received the Indian Drug Manufacturer Associations (IDMA) 2018 'Young Pharmaceutical Analyst Award'.
Publications Patents
- Quality by design approach for development of suspension nasal spray products: a case study on budesonide nasal suspension., Drug development and industrial pharmacy, 03/28/16
- Analytical method development and validation for quantification of flunisolide in nasal spray formulation by RP-HPLC., International Journal of Pharmacy and Pharmaceutical Sciences, 03/01/16
- Development and Validation of UV-Spectrophotometric Method for Budesonide Estimation in Nasal Spray Formulations., Indian Drugs, 04/01/16
- Application of quality by design concepts in development of drug device combination products: A case study on flunisolide nasal spray., Pharmaceutical Development and Technology, 10/01/16
- Liposomal Amphotericin B Nasal Spray for Fungal Sinusitis., Indian Patent Applied Patent application no. 2714/MUM/2008.
- Dry powder inhalation., United States patent application US 13/699,130., 05/13/11
Key Skill Matrix
CE certification, EU MDR 2017/745, MDD 93/42/EEC, RoHS 2011/65/EU, RED 2014/53/EU, 21 CFR Part 820, Article 117 Notified body opinion, IEC 60601-1 (Safety), IEC 60601-1-2 (EMI EMC), IEC 60601-1-3 (Radiation Safety), IEC 60601-2-43 (Radiation Safety), IEC 60601-2-54 (Radiation Safety), IEC 61000-4-x (EMI EMC test methods), ISO 14971 (Risk Management), ISO 13485 (Quality Management System for Medical devices), Leadership, Negotiations, Communication, Interpersonal skills, MDSAP, Notified body audit, Brazil INMETRO, KGMP (Korea), CDSCO, AERB
Timeline
Manager-Regulatory affairs
Company
12.2021 - Current
Senior Manager-Regulatory affairs
Company
12.2018 - 12.2021
Manager-Regulatory affairs
Company
09.2012 - 11.2018
Assistant Manager-Regulatory affairs
Company
08.2011 - 08.2012
Executive-Regulatory affairs
Company
05.2008 - 08.2011
Doctorate - Pharmacy
Marathwada University
Master's - pharmacy
The M.S. University of Baroda
Bachelor's - pharmacy
Pune University
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