Ayaz Dhada
Regulatory Affairs Specialist at GSK
- Role
- Regulatory Affairs Specialist at GSK
- Location
- Bengaluru, IN
- LinkedIn followers
- 500 followers
Experience
Regulatory Affairs Specialist
Oct 2017 — Present · Bengaluru, IN
Responsible for the GRPD regulatory delivery for Renewals of assigned projects with minimal input from line manager.2. Supports Global Regulatory by producing appropriate components, executes agreed dossier strategy, manage multiple project assignments for global regulatory dossiers with minimal input from line manager.3. Training responsibilities for new staff on established departmental processes.4. Completes data assessment to ensure dossier is fit for purpose.5. Identify risks associated with submission data, issues that have business impact.6. Dossier review responsibilities for peers and identify improvement opportunities for Regulatory processes, policies and systems.7. Developing an understanding of regulations, guidelines, procedures and policies relating to registration and manufacturing of pharmaceutical products, to expedite submission, review and approval of global regulatory applications.8. Understands internal/external Regulatory environment.9. Actively builds an organisational network.
Skills
- Glp
- Regulatory Requirements
- Pharmacovigilance
- Dossier Preparation
- Formulation
- Regulatory Affairs
- Renewals
- Sop
- Ind
- Electronic Submissions
- Formatting Documents
- Ich-Gcp
- Regulatory Submissions
- Isi Toolbox
- Ectd
- Gmp
- Variation
- Remediation
- Compliance
- Clinical Trials
- Validation
- Nda
- Gcp
- Annual Reports
- Pharmaceutical Industry
- Pharmaceutics
- Anda
- Fda
- Bookmarking
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