Job Description
Position - Executive / Sr. Executive-CMC Expert ( Regulatory Affairs)
Department : Regulatory Affairs EU Market
Location - Mumbai (Andheri)
Job Description And Responsibilities
• 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
Primary Skills
Primary Skills (essential)
• 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
• Current Expected CTC (Negotiable- Yes / No)
• Notice Period
• Total Experience
• Location
Kindly refer to your friends / colleagues who are looking out for a job change
,
This job is provided by Shine.com
Department : Regulatory Affairs EU Market
Location - Mumbai (Andheri)
Job Description And Responsibilities
• 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
Primary Skills
Primary Skills (essential)
• 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
• Current Expected CTC (Negotiable- Yes / No)
• Notice Period
• Total Experience
• Location
Kindly refer to your friends / colleagues who are looking out for a job change
,
This job is provided by Shine.com
💡 Quick Summary
Seeking a career-building opportunity? The Opening For Sr| Executive|CMC Expert| RA in Pharma MNC |Andheri|E position is now open for candidates interested in the MIS Executive sector. This role in Mumbai offers a professional environment and growth potential.
Requirement Snapshot: Candidates should possess basic communication skills, a proactive attitude, and the ability to work in a team. Experience in MIS Executive is a plus.
