Regulatory Affairs Executive - Pune, India - Fusion Technology Solutions
Description
studying scientific and legal documents to check they meet legal requirements.- gathering, evaluating, organising, managing and collating information in a variety of formats.
- submitting information and responding to queries from bodies such as the Medicines and Healthcare products Regulatory Agency (MHRA).
- 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.
- offering advice about regulations, company policies, practices and systems.
- obtaining marketing permission.
- outlining requirements for labelling, storage and packaging, and approving information leaflets and labels.
- liaising and negotiating with regulatory authorities.
Job Types:
Full-time, Regular / Permanent, Fresher
Salary:
₹286, ₹1,250,761.61 per year
Benefits:
- Health insurance
- Provident Fund
- Work from home
Schedule:
- Day shift
- Morning shift
- Rotational shift
Supplemental pay types:
- Performance bonus
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