Senior Executive - Regulatory Affairs
Senior Executive - Regulatory Affairs
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Job Description
About your role
We have vacancy for CMC expert role in Regulatory Affairs team. We are looking for Sr. Executive. This individual will be based in Mumbai. The candidate has the possibility to utilize his/her own strengths with the support of the professionals.
Your key 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 Vness CTD and eCTD format according to EU regulatory requirements (Candidate will be mainly responsible for CMC / Module 3 work)
- To prepare responses to the quality part of regulatory deficiencies letters according to EU regulatory requirements
- To collaborate with other departments/CMOpartners
- To maintain lists/documents/records
- Responsible for keeping Orion and V.M.D. internal regulatory system current and accurate especially regarding CMC documents.
- To achieve his/her responsibilities within the agreed timescales
- To actively participate in the development of regulatory skills within the regulatory team. Keep up to date with new CMCrelated guidelines.
- Other possible tasks appointed by Supervisors
What 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 highspirit working environment where your skills are appreciated
- Hybrid Work Policy (In a week 3 days work from office and flexibility to work remotely for two times).
- Good worklife balance
- Clear transparent processes and responsible supervisors are our benefits to the personnel
At Orion your work creates true impact and wellbeing for our customers patients and society at culture of friendliness respect mutual appreciation and diversity creates a safe working environment where you can strive for excellence. We offer a wealth of career paths and development opportunities that support the development of innovative solutions and improving the quality of life.
Please visit our website to find further information about our values and Orion as an employer expectations
- 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
Qualification:
Bachelors / Master degree in Pharmacy or Chemistry from a reputed College / University
How to apply and additional information
Email your CV on & please share below details
Required documents CV/Resume
Current CTC Expected CTC & Notice Period.
Application deadline 15.05.2025
Required Experience:
Senior IC
Employment Type
Full-Time
