Regulatory Affairs

Prism life sceinces ltd
Navi Mumbai - Rabale
30,000 - 45,000
/Monthly
Requirements
No experience required
Less than 10th
18 - 42 years
No gender preference
Timings
Working Days
6 days/week
Morning Shift
9:30am - 7:00pm

Job Description

Key duties of the job include:

  • 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 (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
  • 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.
  • Provide responses to regulatory agencies regarding product information or issues.
  • Train staff in regulatory policies or procedures.
  • Coordinate internal discoveries and depositions with legal department staff.
  • Develop and maintain standard operating procedures or local working practices.
  •  Establish regulatory priorities or budgets and allocate resources and workloads.
  • Maintain current knowledge of relevant regulations, including proposed and final rules.
  • Manage activities such as audits, regulatory agency inspections, or product recalls.
  • Participate in the development or implementation of clinical trial protocols.
Additional requirements
Language
English
Previous Experience
Production/ Quality Control/ Maintenance
Job Type
Full Time
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Production/ Quality Control/ Maintenance in Prism life sceinces ltd
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