Litta Elizabeth George
Senior DRA Officer
Manama,Bahrain
Summary
Experienced pharmaceutical professional with a master's degree in Pharmaceutical Sciences and 14+ years in drug regulatory affairs. Seeking opportunity with a global research-based pharmaceutical company in regulatory affairs, quality assurance, or pharmacovigilance to grow professionally and advance career prospects.
Overview
14
14
years of professional experience
6
6
years of post-secondary education
3
3
Languages
Work History
Sr. DRA Officer
Top Pharmaceutical Importer & Distributor
Manama
03.2020 - Current
- Independently managed Health Authority (HA) and government department interactions, collaborating with Principals on regulatory and pricing strategies to drive early market access.
- Delivered comprehensive regulatory services (MAAs and LCM) for over 15 multinational pharmaceutical principals' medicinal and health products.
- Proficient in eCTD (Module 1) and ensured compliant dossier preparation and submissions.
- Currently manages regulatory activities for ~350 innovator products and ~75 manufacturing sites, ensuring HA guideline adherence.
- Collaborated cross-functionally with Principals on regulatory project planning and implemented strategic regulatory approaches for compliance and business objectives.
- Effectively communicated with HAs, built strong regulator relationships, and engaged with KOLs and professional associations ethically.
- Monitored international regulations and provided regulatory intelligence to accelerate local HA approvals.
- Supported Principals with dossier preparation strategies and reviewed documents for high-quality, HA-compliant submissions.
- Liaised with regulatory bodies for MAAs, expedited submissions and approvals, and secured import permits.
- Drove timely submissions and approvals for all LCM activities to ensure compliance and business continuity.
- Experienced with Principal-specific online regulatory portals.
- Provided regular regulatory progress reports and proactive alerts for future planning.
- Managed regulatory archiving and documentation (hard & soft) according to internal, Principal, and local requirements.
- Established effective relationships with key stakeholders both internally and externally for increased collaboration opportunities.
- Implemented process improvements that streamlined workflows, reducing redundancies and increasing operational efficiency.
- Coordinated cross-functional teams to address complex issues, leading to more efficient problem-solving processes.
- Mentored junior officers, providing guidance and support to foster professional development and career progression.
Regulatory Affairs Associate
Leading Pharmaceutical Importer & Distributor
Manama, Manama
01.2016 - 01.2020
- Drove regulatory success by expertly managing Marketing Authorizations (MAs) and comprehensive life cycle management for a diverse portfolio exceeding 20 major Pharmaceutical and Consumer principal companies, with detailed responsibilities outlined below under current employment.
NHRA Registered Community Pharmacist
Major Chain Pharmacy
01.2013 - 01.2016
- Proactively fostered positive community relationships by providing informative health education and promoting preventative care initiatives.
- Improved patient medication adherence by providing comprehensive counseling and follow-up consultations.
- Provided exceptional customer service by addressing individual concerns and prioritizing patient needs.
- Developed strong relationships with healthcare providers, resulting in improved patient care and communication.
- Ensured accurate dispensing of controlled substances, maintaining strict compliance with regulatory guidelines.
- Educated patients on over-the-counter product selection and proper usage, ensuring safe and effective self-care choices.
- Reduced medication errors through diligent prescription review and verification processes.
- Stayed up-to-date with industry trends, attending professional development seminars to maintain knowledge of new medications and therapies.
Lecturer
Jodhpur College of Pharmacy
01.2011 - 01.2012
- Shared in-depth knowledge and expertise in Pharmaceutics and Pharmacology by teaching graduate-level courses, fostering an engaging learning environment.
Education
MASTER OF PHARMACY - PHARMACY PRACTICE
KERALA UNIVERSITY- COPS , MEDICAL COLLEGE
THIRUVANANTHAPURAM , KERALA, INDIA 03.2008 - 03.2010
Professional Diploma in Clinical Research (PDCR) -
CATALYST CLINICAL SERVICES
DELHI, INDIA 12.2008 - 01.2009
BACHELOR OF PHARMACY -
RAJASTHAN UNIVERSITY OF HEALTH SCIENCES-BN COLLEGE
UDIAPUR, RAJASTHAN,INDIA 03.2003 - 03.2007
Skills
Core competencies:
undefinedAccomplishments
- NDA approvals of over 150 drug products, 100 health product presentations.
- Managing average 25 NDA's, 70 product license renewals & 100 other HA applications per year.
- Participated in QMS documentation, review of agreements.
- Participated as internal trainer on PV and QA.
- Authored scientific articles in pharmaceutical research journals.
Professional Registration
Valid Pharmacist license in India & Bahrain
Personal Information
- Passport Number: Z5428807
- Date of Birth: 09/27/85
- Gender: Female
- Nationality: Indian
- Driving License: Have a valid DL from Bahrain
- Marital Status: Married
Disclaimer
The above stated information is true to the best of my knowledge and relevant supporting documents shall be provided upon further request.
Additional Information
Authored scientific articles in pharmaceutical research journals – Paper titled “Chiral drugs as a matter of specialization in modern medicine”, International journal of pharmaceutical and biomedical sciences, Jaya Krishnan S.S and Litta Elizabeth George, Vol 3 (1) Jan – Mar 2012; https://www.researchgate.net/publication/266351952_Chiral_Drugs_as_a_Matter_of_Specialization_in_Modern_Medicine
Paper titled “ In-hospital mortality of intermittent vs daily anti tubercular regimen in patients with meningeal tuberculosis – a retrospective study “, Indian journal of tuberculosis, Thomas Iype , Litta George et al, Jan 2012 https://www.researchgate.net/scientific-contributions/2055163375_Litta_Elizabeth_George
Paper titled “Predictors of Mortality in patients with Meningeal Tuberculosis”, Neurology India, Thomas Iype, Litta George et al, Jan 2012; https://www.researchgate.net/scientific-contributions/71617533_Elizabeth_Litta_George
Timeline
Sr. DRA Officer
Top Pharmaceutical Importer & Distributor
03.2020 - Current
Regulatory Affairs Associate
Leading Pharmaceutical Importer & Distributor
01.2016 - 01.2020
NHRA Registered Community Pharmacist
Major Chain Pharmacy
01.2013 - 01.2016
Lecturer
Jodhpur College of Pharmacy
01.2011 - 01.2012
Professional Diploma in Clinical Research (PDCR) -
CATALYST CLINICAL SERVICES
12.2008 - 01.2009
MASTER OF PHARMACY - PHARMACY PRACTICE
KERALA UNIVERSITY- COPS , MEDICAL COLLEGE
03.2008 - 03.2010
BACHELOR OF PHARMACY -
RAJASTHAN UNIVERSITY OF HEALTH SCIENCES-BN COLLEGE
03.2003 - 03.2007
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