Sr. Specialist Regulatory Affairs

Orion Pharma; Mumbai; On-site; INR 1,500,000 - 2,100,000; Full time

Job summary

Orion Pharma in Mumbai/Hyderabad is seeking a Global Regulatory Expert (Specialist/Sr. Specialist) to lead preparation, checking, and review of registration dossiers and variations in line with EU regulatory requirements.

The candidate should have 7–12 years of international regulatory affairs experience in pharma, with knowledge of EU requirements and ICH guidelines; experience with eCTD submissions is an asset, English proficiency and teamwork are essential.

Qualifications

• 7–12 years in international regulatory affairs in the pharma industry.
• Confirmed knowledge of EU requirements and ICH guidelines.
• Experience with EU dossiers, variations, annual reports and eCTD submissions.

Responsibilities

• Prepare/check/review pharmaceutical/quality parts of registration dossiers.
• Classify changes per EU regulatory variation guidance.
• Prepare responses to regulatory deficiency letters.
• Collaborate with other departments/partners.
• Maintain lists/documents/records and internal regulatory systems.
• Meet agreed timelines and develop regulatory skills within the team.
• Handle other tasks as assigned by Supervisors.

Skills

English fluency

Independent work

Teamwork

Task oriented

Education

Bachelors/Master in Pharmacy/ Chemistry

Tools

Microsoft Office

Job description

Job Summary

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

Responsibilities

• Responsible for preparation / checking / review of pharmaceutical / quality part (all forms) of registration dossiers and variations /amendments / annual reports / renewals as applicable documents and submissions 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

Our expectations

Essential competences, education and way of working

• 7 - 12 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

Qualification

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