Abhishek Raval

Abhishek Raval Email and Phone Number

Seasoned Regulatory Affairs professional l M.Pharm; M.B.A(Pharma Mgt.) l Injectables & OSDs l Set Up of RA Dept l Regulatory (CMC) & Quality Adviser l Trainer l Fostering Sustainability Mindset & Resources Optimization @ Centrient Pharmaceuticals
santa perpètua de mogoda, catalonia, spain
Abhishek Raval's Location
Vadodara, Gujarat, India, India
Abhishek Raval's Contact Details

Abhishek Raval work email

Abhishek Raval personal email

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About Abhishek Raval

Personally:Socialized and Ambitious Samaritan wants to make a milestone development in all fields of life.Professionally:# Considering myself lucky enough to become a unique blend of full of experience versatility by working in person in various departments which includes Regulatory Affairs (Regulated Markets like EU/US/ANZ/CA), Corporate Quality Assurance, QMS, QA (IPQA, Doc. Control), Formulation development, Production (incl. Packing/Store/Dispatch).# Due to above exposure in almost every various single part of Pharmaceutical industries, have developed the 'Hawk Eye' view for the inter-linkages and impact of one task over other department’s procedures.# Also touched up cutting edge concepts affecting the current Pharma industries like planning & management inside the industries, how it gets impacted and its widespread external impact due to factors like Pharmacoeconomics, Public Affairs, Sales & Marketing, Future Industrial trends, Reputation in the eye of health regulatory agencies and due to ever changing global political scenarios.# SWOT analysis at the Industry / Department/ Employee level.# Proven capability in Risk Assessment & Mitigation for day to day manufacturing operations and Regulatory decisions.# Single handedly initiated & developed RA department for regulated markets (Eu, Ca, ANZ, SA). # Basket of RA experience contains different variety of formulations like Tablets (IR, ER), Capsules, Liquid injectables (T.S.& aseptic), Emulsion for injection, Aseptically filled Dry powder injection of antibiotics# Foresightedness in every single activity or system performed in a highly scalable approach and long term competitive environment.Specialties: #International #Regulatory Affairs#Corporate Quality Assuarance#Pharmaceuticals Manufacturing & Quality management system#Risk assessment, inter-linkages and long term internal & external impacts of current practices and change cases#CMC#Freelancing

Abhishek Raval's Current Company Details
Centrient Pharmaceuticals

Centrient Pharmaceuticals

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Seasoned Regulatory Affairs professional l M.Pharm; M.B.A(Pharma Mgt.) l Injectables & OSDs l Set Up of RA Dept l Regulatory (CMC) & Quality Adviser l Trainer l Fostering Sustainability Mindset & Resources Optimization
santa perpètua de mogoda, catalonia, spain
Employees:
559
Abhishek Raval Work Experience Details
  • Centrient Pharmaceuticals
    Function Head - Regulatory Affairs (Global Markets Incl. Us-Eu-Row- Domestic) & Pharmacovigilance
    Centrient Pharmaceuticals Apr 2022 - Present
    Looking after overall Regulatory Function of the company (Vadodara Division) for US, EU, RoW and Domestic submissions. Pharmacovigilance support for US & domestic regions in coordination with outsourced partner. Artworks management, routine commercial support and new product strategy support. Working knowledge for Regulatory softwares like Pharmaready, Extedo, Veeva and QMS softwares like Caliber, Mastercontrol.
  • Unison Pharmaceuticals Pvt. Ltd.
    Manager-Regulatory Affairs - (Regulated Markets)
    Unison Pharmaceuticals Pvt. Ltd. Jul 2018 - Apr 2022
    Ahmedabad Area, India
    Worked as the 'foundation stone' for Regulatory Affairs - Regulated Markets department.Developed & grown an overall sustaining & scalable eco-system in regulatory affairs to enable market penetration in Europe and other regulated markets like Canada, Australia- New Zealand and South Africa.Have successfully filed my own crafted high-quality dossiers for multiple products in all the above regulated regions by working independently at RA and received approvals in best possible time. Successful filings & approvals of moderate to major group variations in EU for overseas clients.Optimization & best use of available resources for present / new products portfolio with parallel development towards its robust quality profile which ensures marketing authorisation in proposed regulated market/s.
  • Baxter International Inc.
    Deputy Manager- International Regulatory Affairs(Eu & Other Regulated Markets)
    Baxter International Inc. Jun 2016 - Jul 2018
    Ahmedabad, Gujarat, India
    Looking after the organization's all regulatory affairs related activities for approved and under approval products concerning Europe region and allied countries.-Handled the team of 6 direct reportees and other indirect reportees under work-shadow.- Review and guidance for routine submissions and any regulatory query responses thereof.-Technical, Regulatory & Soft-skill Training and empowerment of subordinates. -Project & Budget Mapping and Planning of submission of Dossiers, Variations, PSURs, Renewals as per the defined timelines - Liaison with overseas counterparts, regulatory assessors, service providers, associates, or suppliers through tele/web presence. -Presenting departmental achievements & updates in review meetings. - Participating in strategic meetings for submissions or commercial planning, issues or impact meetings for change controls. Making regulatory assessment through Trackwise 8 software.-EVMPD database management & reporting to EMA through the XEVMPD software.
  • Torrent Pharmaceuticals Ltd
    Scientist-Ii (Regulatory Affairs-Eu)
    Torrent Pharmaceuticals Ltd Oct 2013 - Jun 2016
    Ahmedabad Area, India
    - eCTD- Nees Dossier, Supplement, Variation, Amendment, Renewal submission for Europe Union and allied countries.-TTDs, Specifications, APRs, MBD- MPD, Stability Protocol, PVP, MFC, ESR, PDR, DDR, other plant documents & Artworks review and verification.-Management & communications regarding regulatory updates, query responses, variation /dossier submission strategies with partners, associates and suppliers overseas through emails/teleconferences.-Manufacturing control as per approved information through Technical Information Transfer Documents(TITDs).-To respond to queries received from Health authorities, clients and consultants.- To ensure life cycle maintenance of the product using Regulatory Product Information System (RPIS).-Compliance for regulatory/internal audits also to provide supporting information to other depts.
  • Claris Lifesciences Ltd
    International Regulatory Affairs-Reg.Mkts
    Claris Lifesciences Ltd Apr 2012 - Sep 2013
    Ahmedabad
    -CTD, NeeS Dossiers, DMF, Supplements, Variations, Technical Packages Preparation. -TTD, Specifications & plant documents & Artworks verification. -Handling communications with the company's associates, partners, regulatory assessors through emails and tele-conferences from the regulatory affairs point of view.-Handling Management & Communications for Supplier’s Regulatory Data.-Handling communications regarding regulatory updates, query responses, variation/dossier submission strategies with associates overseas.-Liaising with Business Development team for planning submission strategy.-Artwork preparation, Approval and implementation through SAP system.-Responsible for Manufacturing control as per approved Information through Technical Packages.-To respond to queries received from Health authorities, clients and consultants.-Working for all Regulated Markets like Australia, Canada, South Africa, New Zealand, Switzerland including USA & EU regions.-Review of APR
  • Claris Lifesciences, Ahmedabad
    Corporate Quality Assuarance
    Claris Lifesciences, Ahmedabad May 2011 - Mar 2012
    Ahmedabad, India
    All Plants' SOPs Review & Revision Project,GMP Remediation Quality System Project, Training new Joinees on SOP & GMP.Internal Quality Audit and Handling External Regulatory/ SRM Audits,Scribe work during MHRA, USFDA & CAPA GMP audits.Vendor Audit & Approval, Change Control Management, Product Complaint and Recall, Annual Product Review.
  • Nirlife Healthcare (A Nirma Group Company) Rebranded Later As Aculife Healthcare
    Production Officer
    Nirlife Healthcare (A Nirma Group Company) Rebranded Later As Aculife Healthcare Oct 2010 - Apr 2011
    Sachana, Di- Ahmedabad
    -Production of all types of Parenteral Products including Fat Emulsion, Amino Acid Supplements, 50D, NS, RLS, DNS, and Other Injectables-Manufacturing of Fat Emulsion Products (e.g. Propofol), Amino acid Supplements, Irrigation Solutions, Electrolyte & Nutrition Supplements & other Injectables including Aseptic products.-Monitoring regular activities following cGMP, WHO & SOP- Daily shift schedules, production planning, Manpower- machine management & utilization, productivity improvement.-Documentation, Checking & Reconciliations of BMR, all equipment logbooks as per SOP, Standard Cleaning & Operating Instructions- Coordination with other Dept - QA, QC, Maintenance, Store & Micro dept.
  • Zydus Cadila
    F&D Trainee
    Zydus Cadila Aug 2009 - Apr 2010
    Pharmaceutical Technology Centre, Ahmedabad
    Formulation & Development of Different Dosage Forms Like Bilayer Tablets, ER Tablets, IR Tablets, Coated Tablets, AntiFlu Tablet with 12 APIs, Different types of Antacid Suspensions, ER Capsules, Gels, Sachets, Emulsion with Taste Masking Complexation... Etc.

Abhishek Raval Skills

Ms Office All Formulation Machines Operating Skill Pharmaceutics Regulatory Affairs Audit Formulation Development Sop Quality Systems Auditing Cgmp Drug Delivery Marketing Strategy Pharmaceutical Research Quality System Gmp Formulation Quality Assurance Dissolution Ectd Change Control Standard Operating Procedure Pharmaceutical Industry Xevmpd

Abhishek Raval Education Details

Frequently Asked Questions about Abhishek Raval

What company does Abhishek Raval work for?

Abhishek Raval works for Centrient Pharmaceuticals

What is Abhishek Raval's role at the current company?

Abhishek Raval's current role is Seasoned Regulatory Affairs professional l M.Pharm; M.B.A(Pharma Mgt.) l Injectables & OSDs l Set Up of RA Dept l Regulatory (CMC) & Quality Adviser l Trainer l Fostering Sustainability Mindset & Resources Optimization.

What is Abhishek Raval's email address?

Abhishek Raval's email address is go****@****o.co.in

What schools did Abhishek Raval attend?

Abhishek Raval attended The Icfai University, Tripura, Erasmus University Rotterdam, The Icfai University, Tripura, The Icfai University, Tripura, Rajiv Gandhi Prodyogiki Vishwavidyalaya, Rajiv Gandhi University Of Health Sciences.

What are some of Abhishek Raval's interests?

Abhishek Raval has interest in Health, Programmes On Personality Development, Public Speaking, Inspirational Talks And Management.

What skills is Abhishek Raval known for?

Abhishek Raval has skills like Ms Office, All Formulation Machines Operating Skill, Pharmaceutics, Regulatory Affairs, Audit, Formulation Development, Sop, Quality Systems, Auditing, Cgmp, Drug Delivery, Marketing Strategy.

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