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Location:
New Addington, SRY, United Kingdom
Salary:
0
Posted:
March 19, 2010

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Resume:

Ram Shanker Sinha

Contact Details

Address: ***, ***** ****

Croydon, CR06UJ

Country: United Kingdom

Mobile Tel: 075********

Home Tel: 020********

Email: ubyeio@r.postjobfree.com

Introduction: -

A distinct motivated, qualified, and experienced Regulatory Professional with Master in Pharmaceutical Analysis and Bachelor in Pharmacy gained at the University of Strathclyde, UK and UP technical University, India respectively with highest credit.

Career profile:

• Highly organized, detail–oriented, and efficient worker as a team member, as well as an independent contributor and ability to work independently with minimal instructions.

• Strong communication, analytical and problem solving skills, professional maturity and ability to interface across functions with team members at various professional levels.

• Understanding and appreciating the criticality of deadlines and meeting the needs of the company and regulatory authorities, also had an experience with electronic & paper submissions.

• Experience and knowledge of drug regulatory agencies of USA, UK, EU, Canada and also of GMP, GLP, ICH guidelines.

• Computer proficient with expertise in MS-word/excel and complete package of Adobe systems.

Work History

1. EU labelling manager – Pfizer, UK

Contract November 2009 – February 2010

 Monitor EU labelling regulations and Labelling related activities for the products covered under national registration procedure, MRP and DCP.

 Implementation, Creation and review of Artworks, Summary of Product Characteristics and Patient Information Leaflets for submission of MAAs and/or Variations including Clinical overview writing.

 Working with EU Regulatory Strategists on comparison of labelling text across countries and/or against Core Data Sheets (CDSs) in preparation of the Core Safety Profiles (CSPs) submitted to EU Health Authorities with Pfizer PSURs.

 Supporting appropriate use of the Pfizer approved document management database/system (GDMS) for EU labelling, accuracy of labelling lifecycle milestones and ensuring accessibility and availability of accurate and up to date labelling in the EU within the system;

 Support to vendors, in-licensing partners Worldwide Regulatory Strategy, Safety and Risk Management, Pfizer Country Offices and all contributors to and users of labelling text.

 Working with WRO Submissions to ensure delivery of labelling components in appropriate format (i.e. paper or electronic as needed) to meet agreed timelines.

2. Regulatory Associate - Ranbaxy Research Laboratories Ltd.

Permanent Aug 06 - Aug 08

 I was involved in CMC, labelling activities, pre- and post-licensing experience for Regulatory agencies of EU-EMEA/UK-MHRA and USA-FDA.

 Filing of Abridged generic applications across the EU to fulfill the regulatory requirements of dosage forms through National, Mutual Recognition and Decentralized Procedures. To co-ordinate with concerned departments and achieve timely preparation of quality dossiers considering the guidelines and previous deficiencies for registration as per agreed timelines.

 Information, experience and knowledge of proof reading, hyperlinking, intralinking, and reviewing of all relevant regulatory and/or labelling documents.

 Communication with Regulatory Agencies, different departments and clients of company by means of e-mails, telecommunication and vide-conferences for the purpose of training

 Maintain the project planning system for assigned projects/ products, maintenance of existing product registration and database.

 I was also responsible for the Preparation and Submission of Annual Reports, Deficiency Response (as required by agency), Supplement and Amendments for Rx, OTC and PI (literature) in eCTD as well as in paper form.

 I had responsibility of compliance of labels and labelling texts for products with drug regulatory agencies’ requirements.

 I was involved in the preparation of Package Insert in SPL (structured product labelling) and PLR format.

 Signing-off and launching of Package Insert for commercially purpose.

 Preparation and implementation of departmental SOP.

3. Research Assistant - INDIAN INSTITUTE OF TECHNOLOGY (IIT-Delhi) May 06 - Aug 06

 I had done Industrial Research Project on Micro-Encapsulation of Probiotics in which live bifidobacterium was encapsulated in a Calcium Alginate shell, dried and modified into beads for commercial purpose working with the Prof. Subhash Chand and Assistant Prof, Aditya Mittal in department of Biochemical Engineering and Biotechnology .

 My task was to develop calibrate and standardize the method for encapsulation of bifidobacterium. The shape and size of live anaerobic bacteria to be encapsulated for oral usage added to the complexity.

 During project I accustomed to microbiological techniques and handled instruments such as freeze drier, Autoclave, microscopy and its photography, particle size analyser.

4. I got one month Industrial Training at Dabur R&D Centre, Ghaziabad, India, which is a Integral part of Bachelors course. My key learning’s are:-

 I was involved In-process, finished product testing and various other processes in quality control department such as hardness test, friability test, and humidity testing.

 Also I used to conclude and interpret the Exp results, report writing and presentation. Maintaining the Lab records, notebooks and other documents as chromatogram.

 I had given responsibility to calibrate and maintain laboratory instruments, lab documents, and records.

5. I predicted and proposed the inability of anti-mycobacterial drugs against Leprosy/T.B. with the help of Computer Aided Drug Designing softwares such as blast and find out the cause why drug is not 100% efficient against T.B/Leprosy. I completed this research work in Dry Lab at Sai Biosciences Research Institute Ltd, India (ISO certified), and title was Novel Drug Design of anti-mycobacterial drugs.

6. I have completed my Curriculum Research Project on Synthesis of fluorinated compounds via microwave irradiation in University of Strathclyde in co-ordination with University of Edinburgh using analytical & synthetic techniques. The Aim of project is to synthesise and analyse flouorobenzyl compounds by deoxo-fluor, DAST, and Morpho-DAST in microwave at reduced temperature and analysis of final product by TLC, NMR, LC-MS.

Education

1. University of Strathclyde, United Kingdom MSc - Pharmaceutical Analysis (66%) 2008 - 2009

Key learning: - Separation Techniques -HPLC, MS, LC-MS, GC, Spectroscopy, Structural Elucidation and Chemical Analysis

This course, included learning from intense classroom training and gain hand on experience in Lab, gave me an opportunity to rise and updated my analytical techniques, and problem solving skills.

• I handled HPLC and studied it’s used for method development and optimization by using Dry Lab,

• Also learnt and used LC-MS (Tandem, Iontrap & LTQ-ORBITRAP), in bio- analysis, for the estimation of bupivacaine in the plasma sample, and sample preparation by different extraction procedures like protein precipitation and solid phase extraction prior to sample run in to the LC-MS system.

• I possess good knowledge of validation, experimental design, optimization techniques and Management (Drug Regulatory, cGLP & cGMP, audit, equipment qualification).

• I studied chemical analysis, basic chromatography and established the detail knowledge of basic LC, importance of resolution equation, SP, troubleshooting in HPLC and GC, Chiral chromatography, Capillary Electrophoresis, TLC, Wet Chemistry, Structural Elucidation-UV/visible, IR, and NMR, DSC and TGA.

• In detail I also got knowledge about Validation, Equipment Qualification, Drug Regulatory cGLP & cGMP

2. UPTU, Noida, India 2002 - 2006

Bachelor of Pharmacy (73%)

Key learning: - Pharmacology, microbiology, pharmaceutical sciences, analysis, Pharmacognosy, management.

• I gained the knowledge of different dosage forms, synthesis & assay of common drugs, pharmacological action of drug on human body and their toxicity. Also, experience about various QC tests for the tablets like Dissolution, Disintegration, Hardness, Friability tests etc.

• I got hand on practical experience of using UV-Visible spectrophotometer in stability indicating assay and determination of rate of reaction of paracetamol tablets by various manufacturers; I used manual injector HPLC with integrator and learnt quantitative estimation of dosage forms using HPLC.

• I learned titrimetric methods like aqueous, non-aqueous and potentiometric titration for the analysis of the compounds in the dosage forms.

Skills & Competencies

Business Skills

1. Documentation - Expert (1½ - 2 years)

Worked on regulatory documents for 2 years

2. UK and Ireland - Advanced (6 - 12 months)

Studied for one year and doing Part time job for one year so knowledge of working culture of UK

3. Problem Management - Advanced (6 - 12 months)

Transfer of USA based office to India.

4. Research and Development - Expert (3 - 6 months)

All projects which I completed in UG/PG are research based.

5. Proof reading - Expert (1½ - 2 years)

Worked on regulatory documents for 2 years

6. Quality Control - Intermediate (< 3 months)

During project in Dabur accustomed to various QC techniques

7. Seminars - Intermediate (< 3 months)

took part in many seminars at all levels

8. Training - Advanced (< 3 months)

Trained on NMR and commercial launching of drug products

9. Research - Advanced (3 - 6 months)

IIT-Delhi and Project in Sai Biosciences, worked on Novel drug design and microencapsulation of bifidobacterium.

Licenses & Certifications

1. British Red Cross

2. MTOPRA (The Organisation for Professionals in Regulatory Affairs)

3. RSC (in process)

Associations

IPA-Indian Pharmaceutical Association

Visa Information

United Kingdom - Eligible to work fulltime anywhere in UK (Tier-1).

Security Clearance

Central registered body in SCO - Mrs Elizabeth Morrison

Personal Interests

 I had organized and participated in Health awareness campaigns, polio vaccination, blood donation camps, patient counselling conducted with the help of various National clubs, college & govt. authorities.

 I was Runner-up in Basketball competition and also the captain of cricket team during bachelors.

 In out of office hours I like Reading Autobiographies, Cooking, Outdoor Sports, and Travelling.

Other Personal Details

• Trained on Commercial Launching of OTC products and SPL/PLR in USA (New Jersey) by In.vision Research

Corporations in March 2008.

• cGMP Training Seminar - Organized by IPA at New Delhi, India

• I attended annual NMR training in University of Strathclyde in June-2009 under guidance of Prof Sandy gray.

• I was Trained and Certified as Standard First-Aider (including AED), by British–Red Cross in March 2009.

• I participated in 42nd IUPAC World Chemistry Congress in August-2009 in Glasgow, UK



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