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Profile Details

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USD 150 /hr

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Hire Dr. Sarika P.

India

USD 150 /hr

The RAC qualified Regulatory Professional with more than 20 years of experience in the global regulatory submissions.

Profile Summary

The RAC-qualified Pharma Professional with more than 19 years of experience in regulatory, PV, and clinical research. Hold expertise in global regulatory submissions, approvals, and its life cycle management with proficient competency in the US, EU, Canada, TGA, and SA regions for the various dosage forms viz solid orals, hormonal products, ophthalmic preparations, and topical products.
 Hands-on experience with eCTD together with SPL software.
 Management of cost-effective BA/BE study together with CRO audits, their selection, study design, and commercial negotiations.
 Experience in writing and reviewing all dossier modules including administrative, CMC, and Clinical.
 GMP and PV audits
 Due diligence of the dossiers, DMF, and API supplier evaluation.
 Interaction with the Regulatory Agencies to receive clarity at the early stage of product development and during the review process.
 Comprehensive knowledge of the Regulatory Agency’s expectation for successful and fast approval.
 Experience in writing, and reviewing technical documents, protocols, and submission documents.
 Articulating regulatory strategies to accelerate fast-track approvals and support business growth.
 Handling the US FDA/MHRA inspections and writing a response to 483 observations.
 Handling various EMEA Referral procedures like Article 31.
 Regulatory Affairs Department set up experience and development of the regulatory team.
 Knowledge and experience of UK subsidiary set-up comprising MIA, WDA, quality system, the various contractual arrangements with QP/warehouse/QC testing sites, etc.
 Experience with EU and the US launch activities.
 Proven practical knowledge of and ability to deal with complex regulatory issues with the main focus on developing and using an in-house capacity and talent.
 Proven excellence in successfully leading/working in interdisciplinary teams, planning, coordinating, and leading activities simultaneously on multiple projects.
 Works through challenges to remove obstacles. Prioritizes and focuses well. Generates ideas to accelerate the tasks.
 The resourceful, creative, and innovative approach to problem-solving is supported by scientific, and analytical reasoning.
 Proven efficiency in coordination, communication, written, and oral presentation, and organization of tasks, supported by excellent persuasive power.
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 Excellent leadership ability in strategic thinking while maintaining an awareness of the business impact, with timely risk assessment and mitigation.
 Strong planning, organizational, interpersonal skills, and leadership ability.

SUMMARY OF EXPERTISE IN THE PHARMACOVIGILANCE DOMAIN:
 Regulatory and Pharmacovigilance consultant
 Conducting PhV due diligence/audit.
 The Pharmacovigilance Department set up experience and development of the PV team.
 Establishment and Management of PV operations.
 DHPC Procedure handling experience
 Compliance with quality standards, SOPs, ICH-GCP, and/or other guidelines
 Experience in the PV QMS.
 Experience in reviewing PSMF, PMP, PSUR, PADER, RMP, SLA, SDEA etc
 Knowledge of GDPR compliance in the PV domain
 Knowledge of Social media compliance in the PV domain.

SPECIALTIES
Global Regulatory Submissions ANDA, 505 b(2), MAA, ANDS, and WHO pre-qualification, Regulatory Analysis and Intelligence, Regulatory Strategies along with the Risk Assessment, Product Life Cycle Management, Project Planning, and its Management, CRO selection and BE Centre Audits, Cost-effective BE study management. Review of various Contractual Agreements, Pharmacovigilance QMS, DD of PV service provider, Strategic Alliance, and Business Development. Writing Citizen Petition, the USFDA 483 responses, handling of EMEA article 31 referral, PSUA procedures, and other critical PV activities.

Subject Matter Expertise

Services

Writing
Research
Consulting
Product Development

Writing Technical Writing

Research Feasibility Study, Technology Scouting, Gap Analysis, Systematic Literature Review

Consulting Healthcare Consulting, Scientific and Technical Consulting, Regulatory Consulting, Manufacturing Consulting

Product Development Formulation

Work Experience

Founder & Principal Consultant

ABLYREG ADVISORY

October 2019 - Present

GM /Head Regulatory Affairs and Pharmacovigilance

Flamingo Pharmaceuticals Ltd.

January 2013 - September 2019

Sr. Manager Regulatory Affairs (Formulation and API)

Indoco Remedies Ltd

August 2011 - October 2012

Education

Ph.D

SJJTU

July 2015 - January 2019

Masters in Pharmacy

Nagpur University

July 2002 - July 2004

Certifications

ASQ-CQA

ASQ

January 2024 - Present
RAC-US

RAPS, USA

December 2022 - December 2024