ZCL Chemicals Ltd Job Vacancy for MSc/ Ph D

ZCL Chemicals Ltd Job Vacancy for MSc/ Ph D

ZCL Chemicals Ltd Job Vacancy for MSc/ Ph D

We ZCL CHEMICALS LTD (A Group of Advent International) an API manufacturers based @ GIDC, Ankleshwar is hiring for below positions:

1. Senior Manager - Regulatory Affairs with minimum 12 to 16 years of experience & qualification require is M.Sc/PhD. 

Job Description:

Submission of new DMF for various scopes (USA, Europe, CEP,

Canada, Japan, China, Brazil, ROW) providing regulatory inputs in early development phase of APIs eCTD software's and submission gateways like ESG & CESP.

Compilation, review and submission of DMFs globally for new small molecule APIs in eCTD format and in line with ICH and region specific regulatory guidelines. Self review of the complied DMF to ensure that it is error free.

Assessment of Change Proposals from regulatory perspective.

To guide the RA team with updated regulatory guidelines. 

Regulatory strategies for submission of response to queries received from regulatory agencies and customers globally and submission of response within the stipulated timeline.

Life Cycle management of the DMF that are submitted with regulatory agencies and customers.

Amendments and annual notifications submission to regulatory authorities.

Knowledge of eCTD software (Preferably PharmaReady).

Interested candidates of API Pharma Background can send their CV on hiring@zclchemicals.com