Rashmi Pedamkar

To obtain suitable position that will allow me to successfully utilize my professional knowledge and skill for my company, also obtain a job in challenging and dynamic environment to administrate and enhance my skills.

Regulatory Affairs Executive - Charak Pharma Pvt. Ltd. - Worli

(2018-08-13)

• Independently handle end-to-end export regulatory affairs activities for pharmaceutical, Ayurvedic, herbal and nutraceutical products.
• Manage product registrations, re-registrations, renewals, product variations and complete lifecycle management across export markets.
• Prepare, compile, review and submit CTD/ACTD dossiers and all associated regulatory documentation.
• Serve as the front-line contact for international buyers on regulatory documentation and product registration matters.
• Arrange registration samples and all supporting documents required for submissions.
• Handle regulatory queries and prepare deficiency responses within committed timelines.
• Follow up with international customers and regulatory authorities until approvals are received.
• Coordinate with QA, QC, Manufacturing, R&D and other internal departments to gather regulatory requirements.
• Coordinate and support manufacturing site inspections/audits by overseas regulatory authorities and customers.
• Study and interpret regulatory guidelines of existing and new export markets.
• Evaluate new countries and shortlist products suitable for registration based on country-specific regulations.
• Maintain complete, audit-ready regulatory documentation and the registration database.
• Co-ordinate for legalization of documents from embassy.
• Maintain the records like agreements, registration samples, and registered Specification, artwork etc.
• Development of new artwork as per the buyer's requirement and registration requirements.
• Co-ordination with buyers, QA, packaging depart for finalization artworks.
• Artwork checking, shade card approval, maintaining the artworks records.
• Designing of Artwork (Carton, Label, and Leaflet) using Coreldraw, if required.

Regulatory Affairs Executive - Samrudh Pharmaceuticals Pvt. Ltd. - Goregaon (West)

(2015-05 - 2018-07)

• Dossier preparation in CTD & ACTD Format as per ICH Guidelines -ROW markets.
• Co-ordination with Quality Assurance, Quality Control, R&D, Packing, Production for technical documents.
• Prepared dossiers for countries: Azerbaijan, Costa Rica, Congo, Ethiopia, Kenya, Kyrgyzstan, Myanmar, Dominican Republic, Cambodia, Uganda, Ukraine, Uganda, Philippines and Thailand.
• Designing of Artwork (Carton, Label, and Leaflet) using Coreldraw.
• Ensure that all product information & artwork for package labelling is updated when necessary & submitted in correct format & that subsequent approved artwork in accurately recorded & communicated.
• To co-ordinate for the samples to be submitted for registration.

Product Development Executive - Gurjari Impex - Goregaon (East)

(2014-08 - 2015-03)

• Making COA / Specification & MSDS.
• Co-ordinating with parties for purchase and sale.
• Market research for new product development.
• Communicating with target audiences and managing customer relationships.
• Contributing to, and developing, marketing plans and strategies.
• Arranging the effective distribution of our products.

Microbiologist - The Ambassador's Sky Chef - Andheri (East)

(2013-01 - 2013-12)

• Microbiological analysis of food, water and ice cubes.
• Checking hygienic condition of food contact surfaces (using RODAC plates).
• Food adulteration analysis.
• Air sampling, taking hand swabs.
• Chemical analysis of water, detergents and sanitizers.
• Checking Milk and cream fat content.
• Moisture, gluten content of flour sample.
• Taking cooler, freezer temperatures.
• Conduct hygiene audit of the premises.
• Verify all temperature records and other relevant records and their conformance to food safety principles and QMS. Maintaining all HACCP logs.

S.S.C - Maharashtra State Board (2005-03)

H.S.C - Maharashtra State Board (2008-02)

TY.BSc - Microbiology - Mumbai University (2011-03)

PG Diploma - Quality Assurance in Foods / Pharmaceuticals Industry - Sophia College (2012-10)

PG Diploma - Drug Regulatory Affairs in API & Formulation - Institute of Pharmaceutical Management (2015-01)

eCTD Certification Program - Global Institute of Regulatory Affairs (2017-07)