16/07 Ashish Kadam
HR Manager at Autonomy Search

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Regulatory Affairs Specialist - Hospital - M.Pharma/B.Pharma (6-8 yrs)

Ahmedabad Job Code: 10750

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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