🔶 ZCL Chemical LTD Ankleshwar jobs for Regulatory Affairs apply now
🔶ZCL Chemical LTD
Senior Officer / Executive - Regulatory Affairs
Job Highlights
Required Experience: 5+ Years
5 - 9 Years
Vacancy - :1 Vacancy
Location - :Ankleshwar
Not disclosed
Regulatory Affairs, DMF, RA
Job Description
Roles and Responsibilities
Preparation, compilation, reviews of ANDA.
Timely submission of dossier to the USFDA in electronic format (eCTD) and the subsequent life cycle management.
Review all regulatory submission materials to ensure timeliness, accuracy, comprehensiveness or compliance with regulatory standards.
Publishing of various Electronic Submissions for US FDA (eCTD Submissions).
Management of documents in the electronic document management system throughout their life cycle.
Working with Regulatory Publishers in Regulatory Operations to ensure the Modules in electronic document management system are as per regulatory guidelines.
Ensuring compliance with regulations set by the USFDA. Gathering, evaluating, organizing, managing and collating information in a variety of formats.
Keeping up to date with changes in regulatory legislation and guidelines.
Liaising and negotiating with regulatory authorities.
Preparing documentation.
Job role is Not limited to above
Desired Candidate Profile
Required Experience: 5+ Years
Position Based at: Ankleshwar, Gujarat
Industry Type
Pharma, Biotech, Clinical Research
Functional AreaLegal, Regulatory, Intellectual Property
RoleRegulatory Affairs Manager
Employment Type
Full Time, Permanent
Education
Any Postgraduate in Any Specialization
Apply here
Reference - Industrial Guide [Naitik Patel]
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