Summary
Overview
Work History
Education
Skills
References
Interests
Accomplishments
Extra Curricular Activities
Professional Abridgement
The Key Exposure
Work Availability
Timeline
Generic
Soniya Warule

Soniya Warule

Pune

Summary

Having developed a clientele, I travelled extensively in overseas markets. With 15 years of experience in international business development and sales, I have handled key markets like the USA and Latin America.

Overview

15
15
years of professional experience
4
4
Languages

Work History

Apicore Pharmaceutical Pvt.Ltd
08.2018 - Current
  • Job Responsibility
  • API-
  • To market niche & complex APIs across the globe, Europe, the Middle East & Latin American markets.
  • Analyze the market’s new product requirements, patent landscape & competition to design the marketing strategies.
  • To manage customer queries related to novel polymorphic form, ROS/ patent related queries, new molecule development, GMP requirements, on-time USDMF /CEP filing, etc, by coordinating with cross cross-functional team.
  • Identify new products/customer opportunities & increase the market share by innovative strategies.
  • Network with suitable business associates for better market penetration in the Middle East & Latin American markets.
  • To achieve the targeted sales in defined territories.
  • FDFs Licensing -
  • To identify & tap potential partners for Finished drug formulation (Mainly injectables) partnership in Europe & USA markets for Out licensing as well as In-licensing.
  • Part of the new molecule selection process for USA, Europe & other regulated markets through analysis of Orange Book, IMS, Patent landscape & Exim data, etc.
  • To analyse & prepare a commercial forecast with the help of IMS & internal data, prepare an internal cost sheet & project business case.
  • Facilitate licensing activities through lead generation, shortlisting, negotiation /Legal agreement finalization & post-deal management.
  • Coordinate & monitor cross-functional team’s activities, which include IP, product development, data room management, milestone achievement, RA/QA query management, Finance, etc., to achieve set timelines.
  • To perform due diligence, market analysis of each licensing opportunity to evaluate the potential and risks.
  • Mainly handling product categories include Oncology, Iron compounds, Anti diabetic, Antipsychotic, Anti-hypertensive, peptides, etc.
  • Participate in global Pharma events like DCAT & Cphi Worldwide annually.

Wanbury Limited
01.2018 - 07.2018
  • Responsible for sales & business development in North & Latin America markets.

Ipca Laboratories Limited, Mumbai
05.2010 - 08.2017
  • Division- API Export – Sales & Business Development
  • Territories Handled & visited –USA, Canada, Latin & Central America.
  • Job Responsibilities
  • USA & Canada
  • Assist Head-North American operations based out of USA to execute current ongoing API projects by coordinating with cross-functional teams, i.e, RA, QA & Production, which involves technical query management, customer service & regulatory follow-ups.
  • Coordinating customer-specific development projects with R&D, regulatory, and manufacturing locations to achieve the project timelines.
  • To coordinate with the Indian counterparts of the Generic companies in the USA.
  • Coordinating sales & operational activities in the region for commercialized products & helping to achieve targeted sales.
  • Monitor the quality complaints right from the receipt of complaints, coordinating the technical queries, replacement/reimport of the rejected material.
  • Attended the annual DCAT exhibition & established contacts with potential MNCs as well as local manufacturers.
  • Mexico & Central America
  • To achieve the targeted sales budget in assigned countries like Mexico & Central America, which includes Cuba, Guatemala, Costa Rica, Ecuador & The Dominican Republic.
  • Identify old expiring registrations in Mexico markets & tap them for renewal.
  • Travel to assigned countries to visit customers to understand the market dynamics & competition to fine-tune the marketing plan to improve sales and profitability.
  • Identify & network with a suitable business associate for better market penetration in Central American countries.
  • Market research & analysis through Export –Import data of the territories, IMS data to identify new growth prospects, competition & design sales &marketing strategies.
  • To assist the division head in analyzing the division sales data, generating quarterly reports & presentations of the same.
  • Latin America
  • To analyze the market potential in the Latin American continent & initiate the Business developmental activities through appropriate channels.
  • To visit local manufacturers in Brazil markets & acquire knowledge of changing the quality guidelines of ANVISA & strategizing the company’s products in market accordingly.
  • Coordinate internally with Regulatory & R&D departments to priorities the required additional studies related to AMV, FD, Zone IV B, and Photostability as per updated ANVISA guidelines.
  • To target large & medium-scale local manufacturers in the Chile market & develop API products.
  • To monitor the existing business activities in Argentina, Colombia & other Latin region with timely query management, execution of sales orders.

Education

MBA - International Trade

IMDR (Fergusson College)

BSc - Chemistry

Fergusson College

Skills

References

Reference will be provided upon request.

Interests

Travelling, Trekking, outdoor sports, cooking

Accomplishments

  • Successfully achieved budgeted sales in the assigned territories by growing annual turnover to USD 20M (FY 2023) from USD 1.2Mn (FY 2017)
  • Identified potential customers for the company's flagship products & successfully approved them in their dossiers in the USA, EU & MENA markets.
  • Successfully registered Apicore flagship products with the Brazilian health authority with a prospective business of more than USD 4.5 Mn.
  • Appointed agents /distributors in markets like Turkey, Egypt & Latin America.
  • Successfully signed three new FDFs out licensing deals with potential partners in the USA & EU, contributing to sales of USD 10mn during the years 2021 -2023.
  • In-licensed two products for the USA market registration & launch in 2023-24.

Extra Curricular Activities

Winner of National Level Badminton Competition at Quarterfinal level 2002. Winner of Ipca Brainvita Quiz Contest of Year 2010 Completed 10 Km time run of IDBI Marathon, August’16 & Jan’17. Completed half-marathon run of IDBI, August 2017 Completed intermediate level of a Spanish course with 80%, from AIL Madrid-Spanish language school in Madrid, Spain Completed HarvardX course in June 2020 on Prescription Drug Regulation, Cost & Access: Current Controversies in Context in the USA Market.

Professional Abridgement

Pharmaceutical International Marketing. Excellent networking and communication ability, keeping track of the customer needs to identify growth opportunities. Well-versed with regulatory aspects, offering a required techno-commercial skill set for effective business development and marketing.

The Key Exposure

  • Sales and Marketing:
  • -Identifying new product/customer opportunities and increasing market share by innovative strategies.
  • -Evaluating competition & market to fine-tune the marketing plan and improve sales and profitability.
  • Business Development:
  • - Identify and network with suitable business associates to achieve a better market penetration and reach.
  • -Complete coordination with partners & client sourcing team for smooth and profitable operations.
  • -Strengthen relationships with the end-users of the largest countries by supporting them with developmental projects.

Work Availability

monday
tuesday
wednesday
thursday
friday
saturday
sunday
morning
afternoon
evening
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Timeline

Apicore Pharmaceutical Pvt.Ltd
08.2018 - Current

Wanbury Limited
01.2018 - 07.2018

Ipca Laboratories Limited, Mumbai
05.2010 - 08.2017

BSc - Chemistry

Fergusson College

MBA - International Trade

IMDR (Fergusson College)

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Soniya Warule