Manager Marketing
Resume:
CURRICULUM VITAE
Guriqbal Singh
Electronic city , Phase – I
Bangalore - 560100
Mobile: +91-990*******
Email: **********@*****.***
OBJECTIVE & SUMMARY
OBJECTIVE
To pursue a challenging career in professionally managed pharmaceutical organizations with high values and good working environment, where I can utilize my expertise and experience giving way to organizational growth with individual career growth.
SUMMARY
Post-graduate of pharmacy (MASTERS OF PHARMACY) from College of Pharmaceutical Science (COPS), Manipal University, Karnataka, India
62 Months of experience in Regulatory Affairs departments in various reputed pharmaceutical companies and 20 Months of Research experience.
I am well versed with ICH Guidelines, CTD and ACTD requirements and requirements of various regulatory authorities (EMEA, HC Swiss medic, TGA, ANVISA, ASEAN, GCC, CIS, and SADC etc.) quality systems and regulatory compliance.
Successfully filed and secured number of approvals from various regulatory authorities & Countries like HEALTH CANADA, ASEAN Countries, MCC (South Africa), ANVISA (Brazil), TFDA (Tanzania), CIS countries, Central GCC and individual GCC countries, SADC countries, LATAM & African countries.
My skills include exceptional ability to work as a team with good leadership and interpersonal skills, good communication skills, creative and innovative skills, good analyzing skills with practical problem solving ability and have flair for continuous improvement and development.
ACADEMIC QUALIFICATION
Masters in Pharmacy from Manipal Academy of Higher Education, Manipal, Karnataka, May 2005.
Bachelors in Pharmacy from Guru Nanak Dev University, Amritsar, Punjab, April 2002.
Diploma in Pharmacy from SGGS College of pharmacy, Chandigarh, July 1997.
POFESSIONAL SUMARY
Presently Working as Deputy Manager in Regulatory Affairs department (Emerging Market), in Biocon Limited (Since, January – 2011)
Responsible for coordinating with Regulatory agencies across the globe for submission of Dossiers for Biocon and Pfizer. (Biological products)
Presently handling following Region:
SADC countries: Zambia, Mauritius, Madagascar, Botswana, Lesotho, DRC, Malawi, Namibia, South Africa, Tanzania and Zimbabwe.
ASEAN Countries: Singapore, Malaysia, Thailand, Philippines, Indonesia, Vietnam, Cambodia, Myanmar
GCC countries: (Central GCC and Individual countries i.e. UAE, Bahrain, Kuwait, Qatar & Bahrain).
Latin America: Venezuela, Colombia, Brazil, Chile, Peru, Guyana, Suriname, equador, Bolivia, Paraguay, Uruguay, Argentina
Job Responsibilities: (Handling a Team of 7members)
Planning and submission of Marketing Authorization Application as per CTD/ACTD format in line with Country requirements.
Preparation of responses to health authority questions, during registration, and product lifecycle.
Handling of Post Approval compliance activities.
Filing of variation applications.
Maintenance of the project planning system for assigned projects/ products.
Worked as Assistant Manager in Regulatory Affairs department (Emerging Market), in Aurobindo Pharma Limited. (October, 2007 – October 2010)
Responsible for coordinating with Regulatory agencies across the globe for submission of Dossiers for Aurobindo and Customers.
Presently handling following Region:
Eastern Europe: Switzerland, Albania, Kosovo, Macedonia, Serbia, Croatia, Montenegro & Bosnia
CIS countries: Russia, Belarus, Ukraine, Uzbekistan, Khazakistan & Mongolia
ASEAN Countries: Singapore, Malaysia, Thailand, Philippines, Indonesia, Vietnam, Cambodia, Myanmar
GCC countries: (Central GCC and Individual countries i.e. UAE, Bahrain, Kuwait, Qatar & Bahrain).
SADC countries: Zambia, Mauritius and Madagascar.
Handling the customers like Pfizer, GSK, Sanofi Aventis, Cathay Drugs & Astra Zeneca.
Job Responsibilities: (Handling a Team of 43 members)
Technical Review of all Quality i.e. CMC documents for MAA (Marketing authorization applications) filing.
Planning and submission of Marketing Authorization Application as per CTD/ACTD format in line with Country requirements.
Preparation of responses to health authority questions, during registration, and product lifecycle.
Handling of Post Approval compliance activities.
Filing of variation applications.
Maintenance of the project planning system for assigned projects/ products.
Identification of the quality and/or timeliness issues with source documents, as early as possible.
Identification of any potential issues which may affect the quality of the documentation or submission timelines.
Interaction with the Packaging development department for preparation of Draft Labels (inner and outer), Annotated and Non-annotated Product monographs for submission purpose.
Worked as Executive, Regulatory Affairs, in Torrent Research Centre (December 2006 – October 2007)
Job Responsibilities:
Preparation of Dossiers for Regulated and Semi – Regulated Markets viz. Australia, ASEAN, GCC and CIS Market.
Preparation of responses to health authority questions, during registration.
Coordination with plant personnel, Packaging department, Marketing people for various Export orders and samples through SAP/R3
Coordination with Marketing Department for planning of monthly submissions.
Coordination with agents in different countries to fulfill the regional regulatory requirements.
Worked as Executive, Regulatory Affairs, in Ind-Swift Limited, Chandigarh (April 2006 – November 2006)
Job Responsibilities:
Preparation of Dossiers for Regulated and Semi – Regulated Markets viz. Myanmar, Cambodia, Australia, Russia, Uganda, Uzbekistan and Yemen.
Coordination with Marketing Department for planning of monthly submissions.
Coordination with agents in different countries to fulfill the regional regulatory requirements.
ACCOMPLISHMENTS:
At Aurobindo Pharma Ltd
1. Filed 23 dossiers with Swissmedic and got approval for seven products within 12 months time.
2. Submitted 4 dossiers with Health Canada (Tablets, Powder for injection & suspension) and got approval for one product.
3. Submitted 42 dossiers to Brazil and got approval for 34 products.
4. Submitted around 100 dossiers to Spanish speaking Latin American countries like Peru, Venezuela, Chile, Colombia and Costarica.
5. Submitted 200 dossiers to African countries. 121 approvals secured.
6. Submitted 300 dossiers to Asian countries and secured around 180 approvals.
7. Filed 35 dossiers with MOH-Russia and got approvals for nine products.
8. Filed 5 dossiers with Belarus and Ukraine and got approval for all products.
9. Filed 8 dossiers with Health Canada and got approval for four products.
At Torrent Research Centre
1. Filed 8 dossiers with TGA (Australia) and got approval for two products.
2. Submitted 12 dossiers to HSA (Singapore) and got approval for 4 products.
3. Submitted 22 dossiers to GCC countries and got approval for 16 Products.
4. Submitted 30 dossiers to Asian countries and secured around 21 approvals.
5. Filed 5 dossiers with MOH-Russia and got approvals for two products within 18 months time.
At Ind Swift Limited
1. Filed 8 dossiers with Myanmar, 10 dossiers with Cambodia, 4 dossiers for Ubekistan, 2 dossiers with Yemen.
SKILLS
1. Good written and verbal communication skills
2. Flexibility and adaptability skill.
3. Plan and prioritize the projects to meet the timelines
4. Team building and sense of working together to achieve organizational goals.
5. Analytical and problem solving ability.
6. Customer focus & Cost conscious
RESEARCH EXPERIENCE
Submitted thesis by research on “Phytochemical and Pharmacological Evaluation of Saccharum officinarum” for the award of M. Pharmacy degree at NPRD division, Panacea Biotec, Lalru, Punjab under the guidance of Dr. Manjunath Setty, Manipal Academy of Higher Education, Manipal, Karnataka.
Worked as Research Associate in “Mata Vaishno Devi University, Jammu worked on isolation of secondary metabolites from different plants.
PERSONAL DETAILS
Name : Guriqbal Singh
Father’s Name : Late S. Manohar Singh
Date of Birth : 27-02-1979
Nationality : Indian
Language Known : English, Punjabi and Hindi
Marital status : Married
CTC : 8.2 L (Appraisal due in June, 2011)
DECLARATION
I do hereby declare that the above mentioned facts are true to the best of my knowledge and belief.
Thanking you,
Place: Yours Truly,
Date: (Guriqbal Singh)
Contact this candidate