EXECUTIVE – REGULATORY AFFAIRS ~ PHARMANAUKRI.IN

Thursday, November 11, 2010

EXECUTIVE – REGULATORY AFFAIRS

5:23 PM Leo Group India No comments

Summary

Experience:

3 - 4 Years

Location:

Mumbai Suburbs

Education:

UG - B.Pharma - PharmacyPG - M.Pharma - Pharmacy

Industry Type:

Pharma/ Biotech/Clinical Research

Role:

Documentation/Medical Writing

Functional Area:

Healthcare, Medical, R&D

Desired Candidate Profile

QUALIFICATION

• Bachelors/Master degree in Pharmacy

• Required minimum 3 to 4 years work experience in international regulatory affairs from Pharma industry and experience in Formulations Analytical Development, Formulations Development or Pharmaceutical product development activities will be an added advantage

• Good knowledge of EU requirements and ICH guidelines

• Well versed with eCTD submissions

• Task oriented with learning attitude

• Team work skills

• Fluency in oral and written English

• Confirmed skills of Microsoft Office is essential

Job Description

• To assist in building our Indian regulatory team

• Responsible for preparation of pharmaceutical/quality part (all forms) of registration dossiers and variations/ amendments/annual reports as applicable documents in CTD and eCTD format according to EU and USA regulatory requirements.

• Writing of documents as per regulatory requirements

• Response to regulatory deficiencies letters according to EU and USA regulatory requirements.

• Local in-licensing support

• Co-ordination with other departments/partners

• Maintenance of lists/documents/records

• Achievements of the responsibilities with the timelines agreed with supervisor or manager

Keywords: Pharma Regulatory Documentation

Company Profile

Orion Corporation (www.orion.fi) is a pharmaceuticals company who develops, manufactures and markets pharmaceuticals and diagnostic tests worldwide. In Finland, Orion is the leading company as a manufacturer and marketer as well as in R&D of pharmaceuticals. Orion has 3200 employees worldwide. With strong engagement in the promotion of healthcare, Orion has been building well-being for as many as 90 years. Our ambition in the far-sighted research activity is to introduce novel, innovative medicinal treatments for global markets.

Orion Corporation is strengthening its operations in India as part of its ambition to establish a global footprint and undertakes a recruitment-process of the following position in its India liaison office in Mumbai.

GD&PLM (Generics Development and Product Life-cycle Management) is part of Orion Pharma’s R&D organisation and also part of Orion Pharma’s Supply Chain process. It is composed of 5 Departments responsible for evaluating and supporting the development of Orion’s generics products, subcontracting and managing development of new products, compiling files and co-ordinating regulatory processes throughout the world of marketing authorisations as well as supporting production and quality control in their routine tasks, change control, product support, and marketing authorisation maintenance. The GD&PLM participates also in the evaluation of generic products subject to potential in-licensing or contract manufacturing and their subsequent registration.