16/04 Ashish Kadam
HR Manager at Autonomy Search

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Senior Manager/AGM - API Regulatory Affairs - Hospital - B.Pharma (20-22 yrs)

Mumbai Job Code: 14197

We are looking Pharma API regulatory affairs 20+ years of experience candidate for Sr.Manager / AGM role.

Experioence in : Specific regions : US/ EU/ ROW

- Experience in Regulatory filings (US/EU/ ROW) (API) (Global Market)

- Review of in-house Dossiers as per Good Regulatory Practices for its adequacy and accuracy

- Compilation of Regulatory and Non-Regulatory Documents / Dossiers in Regulatory Affairs.

- Compilation of Regulatory Documents (USDMFs/EDQM, ANDAs) in CTD & eCTD format

- Ideal candidate must be having sound Exposure of Regulatory Affairs for US and Europe Market as well as ROW Market (API)

- Submission of DMF submissions with the regulatory authorities within EU,USFDA API filing

- Well versed with Drug Master Files according to the market.

- ASMF filing in European countries

- Submission of Regulatory reports like Amendments, annual updates

- Troubleshooting the technical issues in order to support Business Development Team

- Act as business partnering role to BDM

- Lead team for timely results

He/ she should be able to communicate / coordinate with South Africa and other African country heads / Business teams for Regulatory affairs and Technical aspects.

Coordinate and communicate with internal stakeholders / service providers and provide necessary clarity on regulatory filings and requirements in specific country / territory.

Understanding of strategies to file the US or EU dossiers.

Need to travel to the countries and meet the MOH along with country managers, as and when and if required-

Arrange the Telecons/ Videocons with territory / country heads and update them with Regulatory status, discuss the registration issues and conclude them amicably.

Should have knowledge and understanding for ACTD compilations and filings in APAC countries

Knowledge of Russia / CIS, Latin American filings would be useful.

Good analytical, Communication skills, Planning & organizing and business acumen.

- Result orientation

- Total Experience : 20 + years

- Qualification : B.Pharma or B.Sc.

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