Executive / Senior Executive - Regulatory Affairs (CMC Expert)
FinOrion Pharma India Pvt. Ltd. is looking for an Executive / Senior Executive (CMC Expert) in Regulatory Affairs department. In this position you will be based in Mumbai.
Description of position
- 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
Description of unit
FinOrion Pharma India Pvt. Ltd. (http://www.orionpharma.in) is a wholly owned subsidiary of Orion Group. A presence in India provides an opportunity for Orion Group to strengthen the business relationship with the current partners and support the head quarter in various office activities. The India office focuses mainly on Global Operations and R&D activities.
Global operations (formerly known as supply chain) is one of the core area of operations in Orion's India office. This office is involved in procurement of in-licensed formulated products and pharmaceutical ingredients for in-house manufacturing in Finland. The Packaging Technology team is involved in creating and managing artworks for both in-licensed and in-house manufactured products. The Quality Assurance team is involved in auditing our partners globally to ensure cGMP compliance.
CPD & LCM India (Pharmaceuticals and Regulatory Affairs teams) supports the product life cycle management, maintenance of marketing authorizations and various other documentation requirements for regulated markets. The Medical Communications and Design team in India supports activities such as biostatistics, programming and medical writing tasks.
Orion Corporation (https://www.orion.fi/en) is a globally operating Finnish company that develops, manufactures and markets human and veterinary pharmaceuticals, active pharmaceutical ingredients. The company employs more than 3,000 professionals in different countries. In Finland, Orion is the leading company as a manufacturer and marketer as well as in R&D of pharmaceuticals. With strong engagement in the promotion of healthcare, Orion has been building well-being for 100 years. Our ambition in the far-sighted research activity is to introduce novel, innovative medicinal treatments for global markets.
- 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, high-spirit 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 work-life balance
- Clear, transparent processes and responsible supervisors are our benefits to the personnel
- Bachelors / Masters degree in Pharmacy from a reputed College / University
- 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
- Candidate Information Form: https://forms.gle/MQprzwvciAHpfGSo9
Submit your application as soon as possible and latest by November 30, 2023.
When you submit your application you agree with FinOrion Pharma India Pvt. Ltd. GDPR information notice