Regulatory Affairs - Europe Market For Mumbai @ Sharp Point

Job Description

My client is a Pharma MNC manufacturing formulation & API .

They require Regulatory Affairs professionals for Europe Market

Position - Sr. Officer / Executive / Sr. Executive / Assistant Manager

Department: Regulatory Affairs - EU Market

Location - Mumbai (Andheri)

Experience- 4- 8 Years

Qualification - B.Pharma/M.Pharma

CTC- Upto 8 Lacs only

Roles and Responsibilities

To be responsible for the Life Cycle Management of assigned products,

Preparation of pharmaceutical dossiers and variations
CTD and eCTD format according to EU regulatory requirement

To write, check/review of documents as per regulatory requirements
To response to regulatory deficiencies letters according to EU requirements.

6-8 years' work experience in international regulatory affairs from Pharma industry and Confirmed knowledge of EU requirements and ICH guidelines.

Experience in Formulations Analytical Development, Formulations Development or Pharmaceutical product development activities and eCTD submissions will be an added advantage.

Good understanding for CMC Section
Good Knowledge for Renewal of documents e

Practical experience for Europe Variation fillings

Initial filling and post approval filling activities for all modules

Kindly send me your updated CV on Vi*****a@sh*******t.in

• Current & Expected CTC
• Notice Period
• Total Experience

Kindly refer your friends / colleagues who are looking out for job change.

Warm Regards,
Vishakha Ghadi
Sharp Point HR Consulting
HR Recruiter
Mobile: 9136904***

Email : Vi*****a@sh*******t.in

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Keyskills:   continuous improvement facilitation regulatory affairs product development analytical development hr cv eu api ich pharma filling management regulatory analytical formulation preparation Continuous Improvement Culture Kaizen Root Cause Analysis 5S