Assistant Manager – Regulatory Affairs

Description

About your role

We have vacancy for Global Regulatory Expert role in Regulatory Affairs team. We are looking for Assistant Manager . This individual will be based in Mumbai / Hyderabad. The candidate has the possibility to utilize his / her own strengths with the support of the professionals.

Your key responsibilities

• Responsible for preparation / checking / review of pharmaceutical / quality part (all forms) of registration dossiers and variations / amendments / annual reports / renewals as applicable documents according to EU regulatory requirements.
• To identify and classify the changes as per EU regulatory variation guidance.
• To prepare response to regulatory deficiencies letters according to EU regulatory requirements
• To collaborate with other departments / partners
• To maintain lists / documents / records
• Responsible for keeping Orion internal regulatory system up to date and accurate
• To achieve his / her responsibilities within the agreed timescales
• To actively participate in the development of regulatory skills within the regulatory team by continuous up-dating
• Other possible tasks appointed by Supervisors

What we offer

At Orion your work creates true impact and well-being for our customers patients and society at culture of friendliness respect mutual appreciation and diversity creates a safe working environment where you can strive for excellence. We offer a wealth of career paths and development opportunities that support the development of innovative solutions and improving the quality of life.

Please visit our website to find further information about our values and Orion as an employer expectations

Essential competences education and way of working

Familiarity with Microsoft Office

Qualification :

Bachelors / Master degree in Pharmacy or Chemistry from a reputed College / University

How to apply and additional information

Email your CV on & please share below details

Required Experience :

Manager

Key Skills

Proofreading,Adobe Acrobat,FDA Regulations,Manufacturing & Controls,Biotechnology,Clinical Trials,Research & Development,GLP,cGMP,Product Development,Chemistry,Writing Skills

Employment Type : Full-Time

Experience : years

Vacancy : 1