Regulatory Affairs Specialist
7 days ago
Business: Piramal Critical Care
Department: Regulatory Affairs
Location: Kurla, Mumbai
Travel: Low
Job OverviewTo manage regulatory filings for Europe with minimal supervision, ensuring compliance with eCTD requirements.
Key Stakeholders: Internal- Country Manager
- Plant
- QA
- Artwork Department
- Supply Chain
- PV
- Health Authorities
- Distributors
Reports into the Manager-Regulatory Affairs
ExperienceMinimum 2 years of relevant experience in handling Europe market. Overall total experience in Regulatory of 5 years
Competencies:- Good communication skills in English
- Proficient in using Excel sheets, PowerPoint, etc.
- Ready to take challenges in work
- Ready to move to different locations for work as and when required
- Ability to coordinate intra and inter department and across sites globally
- Good at reviewing documents and having good technical knowledge
- Ability to multitask
Key Roles & Responsibilities:
Under the guidance of the Team Leader, this person should be able:
- To submit the product registration dossier of assigned products to targeted countries in Europe as per eCTD requirements.
- To file all the required variations and Renewals of assigned products in line with guidelines and checklists as per the plan.
- To respond to queries received from regulatory agencies, business unit or other stakeholders by ensuring complete and accurate information is provided within predefined timelines.
- To review product labeling updates in EU.
- To maintain various databases in a timely manner.
- To update himself/herself with the relevant current EMEA, National, and ICH guidelines and requirements.
- To provide required support to Pharmacovigilance team as and when required.
- To ensure support in execution of any projects assigned as per business need.
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