PALAK ARORA
(M.Sc- Biochemsitry, B.Sc- Genetics)
New Delhi
Contact: reach out to resume blaster or email Palak arora
Email: palakarora30@gmail.com
Career Objective:
To pursue a challenging career in the progressive organization which expects a high level of performance and commitment from its employees, where I can continue to make positive contribution of my technical acumen and creativity, acquire new skills and contribute effectively to the organization.
Professional synopsis
Currently working as an Assistant Manager with Kimia Biosciences Pvt. Ltd. Have more than 3 years of experience in Regulatory affairs with registration of formulation (exports- Semi & Non Regulated Market) & bulk drugs registration (imports). In addition hands on experience in – complete documentation, dossier compilation and end to end delivery of commercial supplies.
Proven Expertise
- Supply Chain Management (Beginner)
- Imports Registration
- Exports Registration
- Loan Licensing
- Dual Use Licensing
- Form 10 (Imports)
- MIS Reporting
- Inventory Management
- Import-Export Processes
- Basic Commercial Operation
- Work Flow Management
- Cost sheet Management
- Team Handling
Career History & Highlights
Kimia Biosciences Pvt. Ltd., Delhi – Assistant Manager (Sept.12-Present)
Highlights
- Preparation, Review & Submission of documents pertaining to Imports, Registration of API’s
- Preparation, Review & Submission of documents pertaining to Dual use permission, Form 10, Repacking License, and Loan License.
- Preparation of Dossier/ Technical Package as per CTD modules for registration as per CDSCO.
- Preparation, Review & Submission of documents pertaining to product permission, Re-registration To co-ordinate with other department within organization to carry out various regulatory activities.
- To provide support in the execution of regulatory activities by maintenance and updation of regulatory databases towards providing real time regulatory information on need, under the guidance and instruction of the seniors.
- Maintaining & evaluating data for new drugs, Registration, Re Registrations, Form 10 etc. submissions and approvals.
- Coordination with third parties for obtaining licences from DCGI / FDA
- Handling of Import for API’s, Chemicals & Intermediates with complete handling of documents & follow up with CHA for Clearance of goods.
- Respect / compliance to the given time lines
- Involved in Basic Sourcing & procurement of raw materials & intermediates for R&D projects, commercial campaigns as per established API manufacturing in coordination with team members.
- Tracking inventory management / Inventory management planning/Maintaining stock inventory.
- Monitor stock levels for regular items.
- Preparation & maintain cost sheet in coordination with sourcing team.
- Developing new procedure to improve the efficiency of work.
- Co-ordination with Internal as well as External Auditors & resolving the queries.
- Co-ordination with Logistics Department for delivery of goods on time.
- Maintaining the MIS reports.
- Developing a healthy relationship with internal & external customers.
New Life Pharmaceuticals - Executive (Mar 12 to Sept.12)
Highlights
- Evaluation, compilation & preparation of registration dossiers for African & Asian Countries
- Liaise with local regulatory authority as well as overseas partners pertaining to regulatory affairs, including product registrations, renewals, application of advertisements etc.
- Managing compliance of products in accordance with existing regulations and guidelines
- Preparation of registration applications & support in preparation of responses to Health Authority queries arising from registration applications
Alpa Laboratories Ltd., Indore - Executive (July 10 to Feb.12)
Highlights
- Monitoring, preparing and checking of registration and re-registration dossiers of formulations including prescription products, semi- regulated countries and non-regulated countries.
- CIS countries-Ukraine, Kazakhstan & Russia
- ASEAN Countries - Philippines, Vietnam, Myanmar, Srilanka & Cambodia
- Central American countries - Peru, Guatemala, Panama, Honduras & Costa Rica
- Middle East Asia: Sudan, UAE
- Africa: Kenya, Nigeria, Ghana
- Prepare Summary of product and Pack Information Leaflet (PIL)
- Preparing all submission in accordance with current regulatory requirements or as per guidelines provided in or country specific format.
- Ensuring preparation of documentation according to the requirements of MOH of the concerned country.
- Maintain the records of registered products for renewal of registration.
- Checking for artwork development of packing material for product..
- Co-ordination with quality assurance, quality control, F&D / R &D, packing, production for technical data.
- Co-ordination with production department for timely delivery of finish product to our importer/buyer.
- Preparation of specifications for delivery of product.
Credentials
Educational Qualifications:
- M.Sc. (Biochemistry): CMRIMS College, Bangalore 2010 (66.75%)
- B.Sc. (Genetics): Brindavan College Bangalore 2008 (80%)
Extra Curricular:
- Best Student Award, Brindavan College, Bangalore 2008.
- Co coordinator of various clubs in college
- Won awards in sports & athletics.
- Member of cultural committee for organizing cultural events.
Personal Details
Year of Birth : 1987
Marital Status: Married
Language Known: English, Hindi & Rajasthani
Hobbies: Singing, Crafting & Cooking
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