Piramal Regulatory affairs Executive Job Openings for B Pharmacy, M Pharmacy & Msc Candidates
Piramal Critical Care (PCC), a business unit of Piramal Pharma, is the fourth largest producer of inhaled anesthetics and a global player in hospital generics. ‘Save lives with critical care solutions’ is much more than a purpose statement to us.
We are motivated by our vision of commitment to delivering critical care solutions for patients and healthcare providers across the globe, while achieving sustainable and profitable growth for all the stakeholders.
Piramal Critical Care maintains a wide presence across the US, Europe, and more than 100 countries across the globe. Our product portfolio includes inhalation anesthetics, injectable pain and anesthesia drugs, Intrathecal Baclofen therapy for spasticity management, and plasma volume expanders.
Our products include Sevoflurane, Isoflurane, Halothane, Gablofen, Polygeline, Alfentanil, Fentanyl, Sufentanil and Etomidate. Ability to build successful partnerships has always been an integral part of our growth story.
Piramal Critical Care has strong manufacturing and process development experience with wholly owned, state-of-the-art manufacturing facilities in the United States and India, inspected periodically by US FDA and the UK MHRA and other regulators.
The strategic locations of our facilities help us supply high quality products around the world, timely at optimal costs.
JOB TITLE: Executive Regulatory Affairs
BUSINESS: Piramal Critical Care
DEPARTMENT: Regulatory Affairs
To handle Regulatory Filings for Europe with minimal supervision
KEY STAKEHOLDERS: INTERNAL
Country manager, Plant, QA, Artwork department, Supply Chain, PV
KEY STAKEHOLDERS: EXTERNAL
Health Authorities, Distributors
REPORTING STRUCTURE: Role reports to: Manager, Regulatory Affairs
Positions that report into this role: Nil
QUALIFICATION: B Pharm / M Pharm / M Sc. degree in a related field.
EXPERIENCE: Minimum 2 to 3 years relevant experience in handling Europe market. Over all total experience in Regulatory of 3-5 years
Key Roles / Responsibilities:
The Team Leader will supervise the incumbent with the following:
- Submit the product registration dossier of assigned products to targeted countries in Europe as per eCTD requirements.
- File all the required variations and renewals, of assigned products in line with guidelines and checklists as per the plan..
- Respond to queries received from regulatory agencies, business unit or other stake holders by ensuring complete and accurate information is provided within predefined timelines.
- Review product labeling updates in EU.
- Maintain various data bases in timely manner.
- Update himself/herself with the relevant current EMEA, National and ICH guidance’s and requirements.
- Provide required support to Pharmacovigilance team as and when required Ensure support in execution of any projects assigned as per business need.
- Good communication skills both spoken and written English.
- Should be well versed with using excel sheets, Power Point etc.
- Ready to take on challenges.
- Ready to move to different locations for work as and when required.
- Coordinate with intra and inter department and across sites globally
- Eye for detail while reviewing documents.
Regulatory Affairs Executives. Hiring for Regulatory Filing.
1. BPharm/ MPharm
2. 3-5yrs experience in Regulatory Filing for the European Market.
Application Process : email your CV to Catherine.Cranston@piramal.com Refer to the JD attached.