Swati D. Karande

Ph. : +91-996******* / 91-22-667*****

Email: acsk64@r.postjobfree.com ; acsk64@r.postjobfree.com

To play a key role and make a substantial contribution towards the company’s performance while meeting my personal career aspirations.

Professional Synopsis

Worked with a Pharma Distributor Firm, Lifeline Drug Store Co. LLC, UAE as Head – Regulatory Affairs [From April 2014 to April 2015]

-To facilitate the internal and external regulatory compliance of pharmaceutical products across the UAE region.

-Act as a link between the organization and the regulatory authorities, ensuring that consumer products are in compliance with appropriate local legislation.

-Handling Pharmaceuticals as well as Healthcare registration activities with UAE Ministry of Health.

-Also looking after Derma Cosmetics registrations with Dubai Municipality.

-Handling HAAD and DDC coding processes for covering the medicine under respective insurance process.

-Dealing with Import clearances and well versed with its approval procedures with Ministry.

Worked with Bioplus Life Sciences Pvt. Ltd. as Sr. Manager - Regulatory [From October 2010 to February 2014].

-Filling of eCTDs: with European Authorities via National / MRP as well as DCP procedure for drug product registrations in Europe.

-Handling Pharma as well as Healthcare registration activities in ROW markets like Middle east, South east, CIS, Africa etc.

-Hands on experience and Knowledge of Registration of Medical Devices in EU.

-Proactive follow-up of the submissions including identifying and responding to questions and issues as they arise to facilitate fast track approval

- Heading the department of 10 people. Training them on various aspects of Submissions for all

above mentioned areas and monitoring of their activities.

- Provide active regulatory support to all technical teams to ensure the compliance from

development till launch and further through the product lie cycle. Regulatory Support to

marketing team in strategy planning as we as budget related activities.

Worked with UK based Regulatory Consultancy, Diamond Biopharm Ltd. as Principal Consultant [From April 2009 to October 2010].

-Business Development Activities: Communicating with various customers in Pharma Industry offering a wide range of services across all areas of Regulatory Affairs.

-Worked from India as well as from UK.

-Filling of eCTDs: with European Authorities via National / MRP as well as DCP procedure for drug product registrations in Europe.

-Proactive follow-up of the submissions including identifying and responding to questions and issues as they arise to facilitate fast track approval

-Advice on how to meet individual country requirements to ensure speedy assessment of the dossiers.

-Product Life Cycle Management through variations and renewals of Licences to ensure regulatory compliance is maintained for products on market.

- Managing a team of four people. Training them on various aspects of Submissions for all

above mentioned areas and monitoring of their activities.

Worked with Apotex Research Pvt. Ltd., Andheri (E) As Team Leader in Regulatory Affairs [From March 2007 till March 2009]

- Filling of eCTDs with:

European Authorities via DCP procedure for drug product registrations in Europe.

Other European Markets viz. Turkey, Iceland etc.

Canada Health Authorities (ANDS)

US (ANDA)

Australia (TGA) and Newzealand (Medsafe)

Mostly all the submissions are generic fillings and eSubmissions through a network linked software.

- Handling relevant query responses and communications for all markets stated above.

- Providing details for various site transfer projects i.e. prior approval as well as post approval.

- Managing a team of three people. Training them on various aspects of eSubmissions for all

above mentioned areas and monitoring of their activities.

- Undertaking Regulatory Audits in other pharmaceutical organizations.

Worked with Ipca Labs. Pvt. Ltd. Kandivali(W)As Executive in Regulatory Affairs [From June 2005 till Feb 2007]

- Well versed with Filling of CTDs with MHRA for drug product registration in UK

- Responding to Queries recd. from MHRA with reference to drug product

Applications

The process is Initially National filling of CTDs for EU-generics and then providing details for MRP submissions as well.

-Handling Post Registration Activities w.r.t all technical details required for the submission.

-Managing of the necessary communications for all above activities.

Worked With Goldshield Pharmaceuticals, Andheri (East)As Officer in Regulatory Affairs

[From November 2003 to May 2005]

- Handled Drug Product Registrations and Reregistrations for Australia, Newzeland, Thailand,

South Africa, Vietnam, Malaysia.

- Also handled Renewals and Variation for products registered with MHRA.

Worked With Ipca Labs. Pvt. Ltd. Kandivali(W) As Officer In R& D(F)- Dept

[From June 2000 to November2003]

Handled Dossier Development Projects

Formulations worked on are Tablets, Capsules, Oral Liquids.

Core Competencies And Key Skills

-Well versed with Documentation and Data management.

-Timely achievement of the target.

-Good Communication and follow ups for collection of details from various sources.

-Management of people

IT Skills

Well versed with Documentation Management Systems, Office Automation (Windows, MS Office) and Internet Applications

Well versed with working on the network linked software for all eCTD submissions

Educational Credentials

2000 Bachelor in Pharmaceutical Sciences (B. Pharm) from The Bombay College of Pharmacy, Kalina- Mumbai, University of Mumbai

Driving Licence

YES - Both Indian as well as UAE.

Personal Details

Nationality: Indian

Place of Residence In India: Mumbai

Marital Status: Single

Languages Known: English, Marathi, Hindi

Date of Birth: 19th July 1978

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