Executive/ Sr. Executive Regulatory Affairs

Orion Corporation; Hyderabad; On-site; INR 1,200,000 - 2,000,000; Full time

Job summary

Orion Corporation in Hyderabad, India, seeks a Regulatory Affairs professional with 5–8 years' international pharma experience to manage EU dossier preparation, variations, and responses to deficiency letters. Strong English communication and teamwork are essential.

You will classify changes according to EU guidance, maintain regulatory records, and ensure timely completion of tasks while supporting skill development within the regulatory team.

Qualifications

• Bachelor's or Master's degree in Pharmacy or Chemistry from a reputed college/university.
• 5–8 years' experience in international regulatory affairs in pharma.
• Experience in Formulations Analytical Development or eCTD submissions is a plus.
• Fluency in oral and written English.
• Ability to work independently as well as in a team; task-oriented with a learning attitude.

Responsibilities

• Preparation, checking, and review of pharmaceutical/quality part of registration dossiers and variations per EU regulatory requirements.
• Identify and classify changes per EU regulatory variation guidance.
• Prepare responses to regulatory deficiency letters per EU requirements.
• Collaborate with other departments/partners; maintain lists/documents/records.
• Keep Orion internal regulatory system up to date and accurate; meet deadlines.
• Develop regulatory skills within the team through continuous up-dating.
• Other tasks as assigned by Supervisors.

Skills

Fluent English

Independent work

Teamwork

Task-oriented

MS Office

Education

Bachelor's/Master in Pharmacy or Chemistry

Tools

Microsoft Office

Job description

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

Qualification & Experience

• Bachelors / Master degree in Pharmacy or Chemistry from a reputed College / University
• 5 - 8 years' workexperience 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