Scientist I-IV
- Sentier Consulting
- 10 to 20 Yrs
- Hyderabad
- 5 years ago
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Job Description
Job Purpose:
This position is responsible for leading a group of technical people and guide/assist in technical review and finalization of documents required for regulatory filing in EU.
The position should aim at ensuring accurate and high quality documentation on timely basis to meet organizational requirements and to ensure faster approval with minimal queries.
The position would be responsible for ensuring Regulatory Compliance by keeping the dossier up-to-date throughout the product life-cycle.
Key Accountabilities:
Process/ Operational:
- Competent with EU-filing requirements with respect to Modules 2 & 3. Ability to independently and effectively review technical documents related to Quality Module.
- Well versed with EU-Regulatory Guidance and Processes (i.e. Ability to understand and interpret technical expectations as per applicable ICH and EMEA guidelines)
- Sound knowledge of basic aspects of a Formulation (primarily pharmaceutical development along with general analytical aspects)
- Should be aware of Post-approval variation requirements in EU and have ability to take decisions related to the variation categorization. Should have basic QA knowledge to enable correct review of related change controls and decide on any impact on regulatory front in terms of variation.
Strategic:
Should have excellent work-management and time-management skills. Should have flexibility to handle multiple tasks at a time and ability to plan and execute assignments in case of changing organizational priorities.
People Related:
- Having positive attitude towards work as well as people.
- Should be transparent in dealing with the team members and should be able to guide them to bring the best out of them
- Good interpersonal skills to deal with various cross-functional teams.
Role Holder Profile
Education
M. Pharmacy
Experience
More than 7-years (preferably with sufficient hands on experience in Europe regulatory affairs).
Professional Knowledge
Regulatory Affairs (Formulations), EU Market
Basic Skills
Good written and verbal drafting and communication skills, Sound Computer knowledge of basic softwares (e.g. MS-office).
Employement Category:
Employement Type: Full timeIndustry: Pharma / Biotech
Role Category: Pharmacist / Medical Representative
Functional Area: Not Applicable
Role/Responsibilies: Scientist I-IV
Contact Details:
Company: Sentier ConsultingLocation(s): Hyderabad
Sentier Consulting
We are providing staffing solutions in Pharma/Healthcare for further details kindly follow www.sentierconsulting.co.inWe are based out of HyderabadKindly contact on details given for applying to the post mentioned we would be happy to help you.
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