24 April, 2022
Description of position
As the Senior Executive – Regulatory Affairs, your responsibilities include the following:
- 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
This role will be based in Mumbai, India.
You will have an excellent opportunity to work in an inspiring and important role in the area of Regulatory Affairs and become part of the wholly owned subsidiary of globally operating Orion Group.
Clear, transparent processes and responsible supervisors are our benefits to the personnel
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 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 for ensuring cGMP compliance.
PLM 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.
In Orion we build well-being – together we do work that we are proud of! We strive for excellence in everything we do. We succeed, face challenges, and learn together. Appreciate each other is our key value.
You will also have an opportunity to utilize your own strengths with the support of other likeminded professionals. Orion provides you flexible, high-spirit working environment where your skills are appreciated and we promote good work-life balance.
To be the successful Senior Executive – Regulatory Affairs, you should have the following skills & professional experience:
- Bachelors / Master degree in Pharmacy from a reputed College / University
- A minimum of 4+ years of Regulatory Affairs experience
- Experience on Product lifecycle management will be an added advantage
- Confirmed knowledge of EU requirements and ICH guidelines
- Experience in Formulations Analytical Development, Formulations
- Development or Pharmaceutical product development activities will be an added advantage
- Fluency in English (oral and written)
- Attention to details and accuracy in work
- Develops cross-functional co-operation
- Ability to work on different software and systems
- Ability to work well independently as well as in a team environment
- Task oriented with learning attitude and Teamwork skills
- Maintain regulatory awareness of current regulations and upcoming changes in the regulatory environment
For further information, please call Abhinay Palkar, Senior Manager – Human Resources, during the following times (India): 9:00 am – 5:30 pm on +91 81049 64640.
Please submit your cover letter and CV with your salary request to firstname.lastname@example.org as soon as possible and latest by 30th June 2022.
Join us – together we build well-being and do work that we are proud of!
Apply through this Link