Pharma Regulatory affairs Jobs – Executive / Sr Executive

Executive / Sr. Executive – Regulatory affairs Job Vacancies at Finorion Pharma India pvt ltd

Position: Executive / Sr. Executive

Department:Regulatory Affairs

Company: FinOrion Pharma India Pvt. Ltd.


FinOrion Pharma India is looking for an Executive / Sr. Executive in Regulatory Affairs department. In this position you will be based in Mumbai.

Descritpion of role

Responsible for preparation / checking / review of pharmaceutical / quality part (all forms) of registration dossiers and variations /amendments / annual reports / renewals as applicable documents in CTD and eCTD format according to EU regulatory requirements (Candidate will be mainly responsible for CMC / Module 3 work)
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

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
Good work-life balance
Clear, transparent processes and responsible supervisors are our benefits to the personnel

Requirement

Education : Bachelors / Master degree in Pharmacy from a reputed College / University

Experience :

3 – 6 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

Please submit your application to [email protected] including the following details:

• Total years of experience
• Relevant years of experience
• Current CTC
• Expected CTC
• Notice Period
• Reason for job change

Submit your application as soon as possible, latest by 23.10.2022.

Due to the high volume of responses we receive only suitable candidates will be contacted.

Location : 505, Andheri – Kurla Rd, J B Nagar, Andheri East, Mumbai, Maharashtra 400059