Rutuja Kale
Toronto
Summary
Technical Business Development expert with extensive experience in pharmaceuticals, CRO/CDMO services, and product commercialization. Demonstrates strong proficiency in regulatory pathway assessment, dossier readiness support, and compliance alignment, complemented by active participation in product portfolio studies, market research, SWOT analysis, lead generation, and licensing opportunity evaluation for EU,TGA, HC and ROW markets.
Overview
6
6
years of professional experience
1
1
Certification
Work History
Technical Business Development Executive
Murli Krishna Pharma Pvt ltd
12.2025 - Current
- Gather, analyse, and document business requirements from stakeholders across departments
- Collaborate with cross-functional teams including IT, QA, Manufacturing, and Regulatory Affairs.
- Assist in validation documentation and ensure compliance with industry regulations (FDA, EMA, TGA, WHO)
- Assisted in preparing proposals and contracts for new business opportunities.
Business Development Executive
Zenvision Pharma LLP
06.2025 - 11.2025
- Conducted market research and identified potential business opportunities.
- Participated in trade shows, conferences, and other events to promote company's products or services.
- Analyzed competitor activities in order to understand industry trends and dynamics.
- Developed and implemented strategies to increase customer base and revenue growth.
Regulatory Framework Development Lead
SimWerx
09.2023 - 01.2024
- Supported post-market surveillance activities by collecting and evaluating product data.
- Managed regulatory change required by new and revised laws and regulations, communicating complex requirements and identifying operational impacts.
- Established and oversaw and regulatory procedures.
- Developed strategies to obtain FDA approval for new products.
Technical Officer
Zenvision Pharma LLP
06.2020 - 06.2021
- Conducted literature reviews to support product development initiatives.
- Collaborated with team members to develop innovative solutions for research challenges.
- Performed laboratory tests to evaluate product performance and safety standards.
Education
Master of Business Administration - International Business Management
Narsee Monjee Institute of Management Studies
Mumbai, IN-MHMaster of Science - Drugs, Biologics, and Medical Device Regulatory Affairs
Northeastern University, Toronto
Toronto, Canada01-2024
Bachelor of Pharmacy - Pharmacy
Savitribai Phule Pune University
India05-2020
Skills
- Regulatory Pathway Assessment (EU/TGA/ROW/HC)
- Lead Generation & In/OutLicensing
- Technical-Commercial Proposals
- Cross-Functional Collaboration
- CTD/eCTD Dossier Preparation(CIS)
- ISO 13485/GMP Compliance
- Strategic planning
- CRM software proficiency (salesforce, Apollo, Rocket Reach)
Certification
- Internal Auditing for QMS for Medical Devices based on ISO 13485:2016, TUV SUD South Asia
- Medical Device Establishment Licensing and Post-market Regulation, Health Canada
Languages
English
Full Professional
Timeline
Technical Business Development Executive
Murli Krishna Pharma Pvt ltd
12.2025 - Current
Business Development Executive
Zenvision Pharma LLP
06.2025 - 11.2025
Regulatory Framework Development Lead
SimWerx
09.2023 - 01.2024
Technical Officer
Zenvision Pharma LLP
06.2020 - 06.2021
Master of Business Administration - International Business Management
Narsee Monjee Institute of Management Studies
Master of Science - Drugs, Biologics, and Medical Device Regulatory Affairs
Northeastern University, Toronto
Bachelor of Pharmacy - Pharmacy
Savitribai Phule Pune University