Assistant Manager / Manager - Regulatory Affairs
FinOrion Pharma India Pvt. Ltd. is looking for an Assistant Manager / Manager in Regulatory Affairs department. In this position you will be based in Mumbai.
Description of position
- Responsible for the Life Cycle Management of assigned products according to EU regulations and other country regulations where the products are registered
- Ensure compliance of products with Authority Regulations, decisions & decrees and with Quality system requirements whichever is stringent
- Preparation, Compilation and submission of all the maintenance activities (Renewal & variations) based on company plans and in compliance with Regulatory Authority guidelines; address queries from the regulatory authorities and obtain the approvals
- Coordinate administrative tasks such as ordering translations, legalization, CPP to facilitate submissions
- Change control evaluation
- Responsible for keeping Orion Internal Regulatory systems up to date and accurate
- Keep the regulatory archive complete and ensure that all current licenses and labelling are up-to-date
- Coordination with Internal and External stakeholders for effective implementation of the change
- Follow and comply with all the defined internal policies and procedures of working
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 / Master degree in Pharmacy from a reputed College / University
- Candidates must have 8+ years of RA experience with specific focus on Product lifecycle management
- Europe market exposure is a must
- Experience in Formulations Analytical Development, Formulations Development or Pharmaceutical product development activities will be an added advantage
- Fluency in English (written and verbal)
- Good Interpersonal Skills
- Analyzing and problem-solving abilities
- Develops cross-functional co-operation
- Ability to work on different software and systems
- Familiarity with Microsoft Office applications
- Excellent attention to detail & accuracy in work
- Ability to work well independently as well as in a team environment
- Effective time management skills and ability to prioritize workload
- Task oriented with learning attitude
- Proactive with a desire to learn
- Maintain regulatory awareness of current regulations & upcoming changes in regulatory environment
Please email your updated CV and below requested details to email@example.com with a copy to firstname.lastname@example.org for the screening purpose.
Details required from candidate:
- Total years of experience
- Relevant years of experience
- Current CTC
- Expected CTC
- Notice Period
- Reason for job change
Submit your application as soon as possible and latest by March 31, 2023.
When you submit your application you agree with FinOrion Pharma India Pvt. Ltd. GDPR information notice.