www.goldshieldgroup.com Goldshield Services Pvt Ltd Mumbai : Regulatory Affairs Compliance

[Admin]

Designation : Executive Regulatory Affairs & Compliance

Job Description :
Timely filing of complete, high quality submissions, prompt, complete and accurate responses to RFIs and effective communication of approvals
a) Varying licences in markets that allow for this procedure
b) Preparing and filing renewal applications as per renewal schedule in concerned markets.
c) Checking and reviewing product artwork for country specific regulatory compliance.
d) Updating and being accountable for all the status logs maintained by the Unit for allocated molecules.
e) Implementing and Complying with the SOPs in effect.
•100% accurate and complete recording of all regulatory submissions, correspondence with authorities and approvals and any associated logs.
•All Helpdesk queries are answered in accordance with SLAs.

Desired Profile :
-A minimum of 1 years experience in regulated markets
-2 years experience in regulatory affairs.
-Experience in technical aspects of pharmaceutical product manufacture
-Knowledge of European Regulations, Guidelines and Application Procedures

Experience : 1 - 3 Years
Location : Mumbai

About us:
Goldshield Group Limited (Goldshield) is a marketing-led British Pharmaceutical and Consumer Health company. The company markets its products in more than 50 countries across the globe with primary focus in UK and EU markets. Goldshield has operational base in the UK, USA and India.

Goldshield sells prescription pharmaceuticals, non-prescription medicines, vitamins, minerals and supplements and a wide range of other healthcare products.

Contact : Sneha / Rashmi
Goldshield Services Pvt Ltd
Akruti Trade Centre, 5th Floor, JVG Industrial Lane, Road No. 7,
MIDC, Andheri East,
Mumbai - 400093. India
Telephone: +91 22 6678 4444
Facsimile: +91 22 6677 1262
Email : hrrecruitment@goldshieldplc.com
Website : www.goldshieldgroup.com

[pallavi ambre]

Curriculum Vitae

Pallavi Gangaram Ambre. Address:
Email: pallavi_gd_2007 AT rocketmail.com

CAREER OBJECTIVE:
Aspiring for a challenging job wherein my qualification and acquired skills are put to best use which would provide me an opportunity to learn and grow professionally to my full potential.


TRAINING :
TAHIRA INDUSTRY (I) PVT LTD.
PARENTAL INDUSTRY as a trainee
Key Responsibilities:
o Worked as a trainee in quality control department.
o Trainee in production department

WORK EXPERIENCE:
At present working with GLOW LIFE SONS vasai (east) in the production department of tablet and capsule from last one month as assistant production chemist


RESPONSIBILITY :

- Batch Manufacturing compression, and coating.
- Inter departmental follow-up with Q.C. stores maintainance etc.
- Production planning, implementation of systems and laid down procedures like SOP’s, BMR and their periodic review.


ACADEMICS
Professional Qualification :
- PASSED B-Pharm VIII Sem From Mumbai University in May 2010 with Distinction.
- Passed B-Pharm VII Sem From Mumbai University in Nov 2009 with 1st class.

B.PHARM SEMESTER UNIVERSITY INSTITUTE YEAR OF PASSING
PERSEN TAGE
SEM-II Mumbai University Degree College of Pharmacy ,Sawarde May-2007 61.85%
SEM-IV Mumbai University Degree college Of pharmacy,Sawarde May-2008 60.83%
SEM-VI Mumbai University Degree College of Pharmacy ,Sawarde May-2009 66.54%
SEM-VII Mumbai University Degree College of Pharmacy ,Sawarde Nov- 2009 68.33%
SEM-VIII Mumbai University Degree College of Pharmacy ,Sawarde May-2010 70.22%

Education Qualification :
- Passed First Year B.Sc. examination from Mumbai University in April 2006 with 1st class .
- Passed H.S.C. examination from Maharashtra State Board in Feb 2005 with 1st class.
- Passed S.S.C. examination from Maharashtra State Board in March 2003 with distinction.

COMPUTER SKILLS:

- Basic of computer

INTERESTED WORK AREA:
1 Production and Development
2 Quality assurance
3 Regulatory affair
4 Research & Development

EXTRA CURRICULARS:

Hobbies and Interest :

1 Make new friends
2 To learn new thing

PERSONAL INFORMATION:

Nationality: Indian.
Date of Birth : 22nd July, 1987.
Martial Status : Single
Languages : English, Hindi, Marathi.

DECLARATION:

I hereby declare that all the above stated details are true to the best of my knowledge.


Place : Mumbai

Date :



(Miss PALLAVI GANGARAM AMBRE)