Reading about various Global Regulations
Rachana Tare
Regulatory Affairs Specialist
Indore,India
Summary
Well-organized and diligent Regulatory Affairs Specialist adept at coordinating and tracking regulatory-related actions. Highly successful at keeping on top of changes in requirements to maintain flawless compliance. Offering 8 years' experience in Pharmaceutical and Medical device industries and looking for a challenging new role.
Skilled at preparing and submitting regulatory documentation, including reviewing materials, technical data and accuracy of filings. Articulate and personable with exceptional data analysis, report writing and recordkeeping abilities.
Overview
8
8
years of professional experience
8
8
years of post-secondary education
3
3
Certificates
3
3
Languages
Work History
Regulatory Affairs Specialist
Tata Elxsi
Pune, Maharashtra
01.2021 - Current
- Consolidated global information relevant to [Product or Service] and monitored global submissions and approvals status.
- Prepared and submitted regulatory file applications and supporting documentation.
- Performed and documented quality control checks to maintain compliance with company initiatives.
- Reviewed [Type] data to assess compliance with [Type] regulations.
- Recommended improvements to processes.
- Used [Software] to create product technical file packages for global product compliance certifications of [Type] products.
- Wrote or updated standard operating procedures, work instructions or policies.
Regulatory Affairs Executive
Medline Industries India Pvt. Ltd.
Pune, Maharashtra
02.2018 - 01.2021
- Exceeded goals through effective task prioritization and great work ethic.
- Learned new skills and applied to daily tasks to improve efficiency and productivity.
- Proved successful working within tight deadlines and fast-paced atmosphere.
- Participated in continuous improvement by generating suggestions, engaging in problem-solving activities to support teamwork.
- Collaborated with team members to achieve target results.
- Developed and maintained courteous and effective working relationships.
- Prepared variety of different written communications, reports and documents.
Business Process Lead/ Pharmacovigilance Scientist
TCS
Mumbai and Pune, Maharashtra
06.2014 - 02.2018
- Performed data entry operations to update database with customer responses.
- Mentored and guided employees to foster proper completion of assigned duties.
- Performed quality assurance checks on transactions and account actions to assess compliance with state and federal regulations.
- Positioned as go-to person for up to [Number] staff members, troubleshooting complex administrative and training issues promptly.
- Assisted with new hire processing and existing training programs.
- Coordinated weekly meetings for internal and external groups.
- Built strong relationships with customers through positive attitude and attentive response.
- Initiated timely response to emails, voicemails and written correspondence.
- Collected, arranged and input information into database system.
- Evaluated staff performance and provided coaching to address inefficiencies.
Education
Master of Science - M.Pharm (Quality Assurance)
Dr.L.H.Hiranandani College of Pharmacy,Thane, Affi
Thane (Maharashtra) 11.2011 - 09.2013
Bachelor of Science - B. Pharmacy
School of Pharmacy, Devi Ahilya Vishwa Vidyalaya
Indore, (M.P.) 11.2007 - 07.2011
No Degree - Higher Secondary
St. Mary's Convent Sr. Sec. School
Dewas, M.P. 06.2006 - 06.2007
No Degree - Secondary (10 Th) (CBSE Board)
St. Mary's Convent Sr. Sec. School
Dewas, M.P. 06.2004 - 07.2005
Skills
Data verification
undefinedAccomplishments
- Achieved results through effectively helping with the tasks.
- Supervised team of 4 staff members.
Certification
Registered Pharmacist
Interests
Sketching in free time
Timeline
CQI and IRCA QMS Auditor Training ISO 13485 certification
05-2021
Regulatory Affairs Specialist
Tata Elxsi
01.2021 - Current
Regulatory Affairs Executive
Medline Industries India Pvt. Ltd.
02.2018 - 01.2021
Business Process Lead/ Pharmacovigilance Scientist
TCS
06.2014 - 02.2018
Master of Science - M.Pharm (Quality Assurance)
Dr.L.H.Hiranandani College of Pharmacy,Thane, Affi
11.2011 - 09.2013
Graduate Pharmacy Aptitude Test (Rank: 3697)
09-2011
Bachelor of Science - B. Pharmacy
School of Pharmacy, Devi Ahilya Vishwa Vidyalaya
11.2007 - 07.2011
No Degree - Higher Secondary
St. Mary's Convent Sr. Sec. School
06.2006 - 06.2007
No Degree - Secondary (10 Th) (CBSE Board)
St. Mary's Convent Sr. Sec. School
06.2004 - 07.2005
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