Regulatory Affairs Executive
Regulatory Affairs Executive
Piramal Pharma
Job description
Want to move ahead in your career in pharmaceutical regulatory affairs? Check out this Regulatory Affairs Executive role with Piramal Pharma at Kurla, Mumbai.
Company Description
Piramal Pharma is a global pharmaceutical company with businesses serving healthcare markets worldwide. Its Piramal Critical Care division specialises in hospital generics and inhaled anaesthetics, including Sevoflurane, Isoflurane, and Halothane. The division serves customers across the United States, Europe, and more than 100 countries, supported by manufacturing facilities in India and the United States.
Job Summary
The Executive- Regulatory Affairs position would be based in Kurla, Mumbai and will help in regulatory compliance for pharmaceutical products for EU and RoW markets. As a regulatory officer, you will develop and review submission documentation, coordinate information with project teams, respond to requests from health authorities and support regulatory modifications across the product life cycle. The role requires a relevant scientific qualification and 2–4 years of experience in working with European and/or other international markets.
Key Responsibilities
Prepare and submit regulatory documentation for new marketing authorisations, modifications and renewals for designated markets.
Review of application dossiers, Summary of Product Characteristics (SmPCs) and labelling materials to ensure compliance with applicable legislation and local requirements.
Coordinate and manage change-control activities resulting from regulatory requirements.
Liaise with project teams to obtain the information and documents required for submissions.
Develop draft replies to health authority Requests for Information (RFIs) and review response packages for correctness and timely submission.
Work with artwork and labelling teams to co-ordinate product label revisions and implement changes relating to serialisation authorisation transfers and variants.
Support requests for supporting papers, e.g. Certificates of Pharmaceutical Products ( CPPs ) and regulatory declarations.
Maintain regulatory records, product details, electronic filing systems, activity monitors, and databases.
Educational Qualification
B.Pharm, M.Pharm, MSc or an equivalent qualification in a relevant scientific discipline.
At least 2–4 years of relevant experience handling regulatory affairs activities for European markets and/or Rest of the World territories.
Skill Required
Excellent written and oral communication abilities in English.
Experience with Microsoft Office, especially Word and Excel.
Understand pharmaceutical regulatory documentation and filing processes.
Ability to review technical materials and evaluate information attentively.
Excellent organization and coordination skills.
Able to manage several projects and meet regulatory deadlines.
Ability to operate independently and in collaboration with multinational teams.
Strong time management and task prioritization skills.
Detail oriented and dedicated to correct documentation.
Accountability, initiative, and responsibility for assigned duties.
Scientific knowledge applicable to the pharmaceutical or allied industries.
Salary Structure
The anticipated compensation range for a Regulatory Affairs Executive in India is ₹10-12 Lakhs per annum.
Career Development
This position as a compliance and regulatory officer can help people develop a skill set in foreign regulatory submissions, pharmaceutical compliance and product lifecycle management. Liaising with health authorities and multinational teams can also develop abilities in regulatory planning, documentation and project coordination.
How to Apply
Visit our job portal and search for Regulatory Affairs Executive role.
Choose the job to view details.
Fill out the application form and upload resume.
Submit your application.
Education
Bachelor's Degree
Key Skills
Market insights & trends
Salary Insights
The amount of money that gets paid can be different depending on how they have been working, where they live and what kind of job they are doing. Some places pay more than others. Most good jobs include extra money for doing a good job, health insurance and flexible hours. Companies pay high salary to make sure they can get the people they want.
Hiring Trends
The number of jobs for this profile is going up every year. Hospitals and other healthcare companies are looking for people who're good, at their job and can also figure out new problems. They want who can do the work and also think on their feet to deal with the challenges of working in healthcare today.