Piramal Pharma Solutions Regulatory Affairs Job Vacancies 2022
Piramal Critical Care (PCC), a business unit of Piramal Pharma, is the third-largest producer of inhaled anaesthetics 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 anaesthetics, injectable pain and anaesthesia 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 a strong manufacturing and process development experience with wholly-owned, state-of-the-art manufacturing facilities in the United States and India, inspected periodically by the 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, Operations
BUSINESS: Piramal Critical Care
Assist in the preparation, review and submission of various electronic applications to the Food and Drug Administration (FDA), European Union (EU) and other regulatory bodies
KEY STAKEHOLDERS: INTERNAL
Cross-Functional: Sales, Marketing, Manufacturing, Supply Chain, Medical Affairs, Quality Assurance, Quality Control, Pharmacovigilance, Planning, Program Management
KEY STAKEHOLDERS: EXTERNAL Health Authority (HA)
REPORTING STRUCTURE: Manager, Regulatory Affairs Operations.
QUALIFICATION: B.S. degree or equivalent in a science or related field preferred.
- Good Manufacturing Practice (GMP) knowledge preferred.
- Experience with document management systems and publishing software (tools) to support electronic submission publishing. Working knowledge of eCTD structure and requirements.
- 1 to 3 years relevant regulatory publishing experience in US and EU markets.
- Experience with Lorenz docuBridge highly preferred.
Key Roles / Responsibilities:
- Publish Electronic Submission of registration dossier, variations, annual reports and responses to questions in eCTD format via the Electronic Submissions Gateway (ESG), Common European Submission Portal (CESP) or equivalent submission portal utilizing in-house publishing software.
- Prepare documents for submission by scanning, rendering, bookmarking, and hyperlinking.
- Perform quality checks for document integrity and compliance to regulatory standards.
- Troubleshoot document issues and provide guidance to company employees on best practices and regulatory requirements.
- Prepare and maintain electronic templates that will be used company-wide for preparation of submission documents.
- Convert paper submissions to electronic publishing, as required. Submit Structured Product Labeling /Drug Listings to FDA via the Electronic Submissions Gateway (ESG), as required.
- Submit Establishment Registrations to FDA via the Electronic Submissions Gateway (ESG), as required.
- Prepare and submit safety reports to FDA and Health Canada via the ESG, as required;
- Manages compilation and submission of Periodic Adverse Event Reports for USFDA, as required.
- Update himself/herself with the relevant current USFDA, EMEA and ICH guidance’s and requirements.
- Ability to work independently and within tight timelines.
- Organized and able to prioritize submissions. Will need to collaborate intra and inter department and across sites globally to achieve the necessary objective.
- Should be meticulous and detail oriented in his / her work including the review of documents and should have good technical knowledge.
- Should be able to multi-task effectively.
Application Process :
Interested & Eligible Candidates Share your Resume to Catherine.Cranston@piramal.com