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Orion Pharma
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Senior Executive

Senior Executive

Orion Pharma

5 - 8 years

5 - 9 Lacs

mumbai

Posted:3 hours ago| Platform:

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Skills Required

supervisor chemistry senior executive analytical pharmacy pharma regulatory affairs ms office senior executive regulatory affairs ich

Work Mode

Work from Office

Job Type

Full Time

Job Description

About your role

We have vacancy for Global Regulatory Expert role in Regulatory Affairs team. We are looking for

Executive/Sr. Executive. 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

An excellent opportunity to work in an inspiring and important role in the area of Regulatory Affairs
Great opportunity to become part of the wholly owned subsidiary of globally operating Orion Group
Possibility to utilize your own strengths with the support of the professionals
Flexible, high-spirit working environment where your skills are appreciated
Hybrid Work Policy (In a week - 3 days work from office and flexibility to work remotely for two times).
Good work-life balance
Clear, transparent processes and responsible supervisors are our benefits to the personnel .

Our expectations

Essential competences, education and way of working

5 - 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.
Fluency in oral and written English
Ability to work well independently as well as in a team environment
Task oriented with learning attitude and Team work skills
Familiarity with Microsoft Office

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