Aswini Sofia Pachala Immanuvel
Regulatory affairs| CMC author&review| Data analyst| Conformance &Compliance of regulatory| Specialist MENA, LATAM, US, EU MRP DCP, APAC markets life cycle and post approvals
- Role
- Senior Specialist - Regulatory Affairs Grs at 百时美施贵宝
- Location
- Hyderabad, TG, IN
- LinkedIn followers
- 500 followers
About Aswini Sofia Pachala Immanuvel
Experienced Regulatory Affairs Profesional with a demonstrated history of working in the core Pharmaceutical organization skilled in Software tools like MS Office systems (Word, Excel, PowerPoint,HTML) and advanced regulatory tool eCTD publishing Pharma Ready, eCTDXpress, Docubridge, PDS, Oracle, Liquent, Track wise.Knowledged about submitting regulatory documents and dossiers in IND/NDA/ANDA,510(k) through CTD platform as per FDA and country regulated guidelines.*Experienced in Compliance to conform on Site illustrated activities through managing data in system which directly is concerned to manufacturing site batch releases.*Experienced in answering MoH queries and responses by frequently Collaboration with global stakeholders, regional regulatory strategists, country leads, CMC strategists and Hub Submissions managers which derives role of an Global operations.*Knowledged in handling of clinical data operation and phase 1 related studies through CARA publishing output.*Comprehensive and demonstrative understanding on process MAH and or Licenses in EU, EMA, Latin, APAC, MENA, US markets as I worked with global stakeholders.*Thorough understanding and knowledge about cGLP, cGMP, cGCP, QMS, PSUR, WHO, ICH guidelines which afore requires for compilation per the standards.Always looking for role expansion which helps me to grow professionally stronger and or learning which aspires to be a better professional in the field of Regulatory Strategy which had come through my educational background being specialised in Pharmaceutical Regulatory Affairs from a well known university.Soft tools: MS office systems.Social tools: Teams, Skype, Linkedin, Cisco, Google.Language proficiency: English, Spanish, Telugu, Tamil, Hindi.Get in touch to know more.
Experience
Senior Specialist - Regulatory Affairs Grs
Feb 2024 — Present
Education
Dr MGR Educational and Research Institute
B.Pharmacy, Pharmacy
2011 — 2015
JSS College of Pharmacy, Ooty - "Ootacamund"
M.Pharmacy, Regulatory Affairs
2016 — 2018
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