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Regulatory Affairs Manager

5 - 8 years

2 - 6 Lacs

surat gujarat india

Posted:1 day ago| Platform: Foundit logo

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Skills Required

data collation documentation regulatory inspection management labelling packaging & storage compliance negotiations

Work Mode

On-site

Job Type

Full Time

Job Description

  • 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

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