HR Manager at Autonomy Search
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Regulatory Affairs Specialist - Hospital - M.Pharma/B.Pharma (6-8 yrs)
We have career opportunity as Regulatory Affairs Specialist at Ahmadabad.
Experience in US & Europe Regulatory Affairs.
Min Experience : 6 years
Qualification : B.Pharma/M.Pharma
Responsibilities:
- Studying scientific and legal documents
- Gathering, evaluating, organising, managing and collating information in a variety of formats
- Ensuring compliance with regulations set by the Medicines and Healthcare products Regulatory Agency .
- Maintaining familiarity with company product ranges
- Planning, undertaking and overseeing product trials and regulatory inspections
- Keeping up to date with changes in regulatory legislation and guidelines
- Analysing complicated information, including trial data
- Offering advice about company policies, practices and systems
- Obtaining marketing permission
- Outlining requirements for labelling, storage and packaging
- Using a variety of specialist computer applications
- Liaising and negotiating with regulatory authorities
- Providing advice about regulations to manufacturers/scientists
- Writing comprehensible, user-friendly, clear product information leaflets and labels
- Ensuring that quality standards are met and submissions meet strict deadlines
- Preparing documentation.
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