Business: Piramal Critical CareDepartment: Regulatory AffairsLocation: KurlaTravel: Low
Job Overview
The Executive Regulatory Affairs is responsible for the portfolio of Piramal Critical Care/Piramal Pharma Ltd products in the ROW and Latam region(s). He/She will be the primary point of contact with the manufacturing site in the USA, INDIA, CMO (Contract Manufacturing sites) and will be responsible for the coordination of document requests in support of global regulatory submissions. The incumbent will also assess, manage, and track change controls from regulatory perspective for the US/India/CMO and facilitate regional or global regulatory assessments within the RA department. Also he/she will be responsible for obtaining documentation to support the compilation and submission of DMFs, CTD , ACTD and Regional Dossiers, Variation/Renewal filings, Support to APQR’s, Tender Filings, OEF approvals, Sample arrangements/dispatch and maintenance of regulatory database / repositories.
Essential Duties And Responsibilities
- Serves as the primary point of contact with the US / INDIA / CMO facility for the coordination of document requests in support of global regulatory submissions
- Assesses, manages and tracks change controls for the US/India /CMO sites and facilitates regional or global regulatory assessments within regulatory affairs department
- Reviews the regional website for relevant updates or notifications for new regulations and guidance documents.
- Supports global regulatory submissions by obtaining complementary elements such as CPPs, Apostilled and Legalized documents
- Obtains documentation from various departments to support the compilation and submission of CTD , ACTD and Regional Dossiers, Variation/Renewal filings, Tender and Special Import Filings
- Compiles and submits amendments to Drug Master Files for the Regional ROW markets.
- Assists in managing the Renewal/Retention of registrations for Human/Veterinary drugs in the ROW and LatAm markets
- Assists as needed with both pre-market (Company / Site Registration/GMP approvals) and post market submissions (Variations) in the ROW and LatAm markets
- Coordination with Labelling and Artworks teams for generation of Standard / Country Specific artworks/Packaging.
Essential Education/Experience Required
- M-Pharm, B-Pharm, MSC, in scientific discipline or equivalent education.
- Minimum of 6 Month to 2 years of regulatory affairs experience required
- Previous experience / Knowledge of Regulatory Dossier preparations.
- Strong knowledge of FDA and ICH guidance documents
- Good Manufacturing Practice (GMP) knowledge required
About Us
In the three decades of its existence, Piramal Group has pursued a twin strategy of both organic and inorganic growth.Driven by its core values, Piramal Group steadfastly pursues inclusive growth, while adhering to ethical and values-driven practices.
Equal employment opportunity
Piramal Group is proud to be an Equal Employment Opportunity and Affirmative Action employer. We do not discriminate based upon race, ethnicity, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, genetics, or other applicable legally protected characteristics.We base our employment decisions on merit considering qualifications, skills, performance, and achievements. We endeavor to ensure that all applicants and employees receive equal opportunity in personnel matters, including recruitment, selection, training, placement, promotion, demotion, compensation and benefits, transfers, terminations, and working conditions, including reasonable accommodation for qualified individuals with disabilities as well as individuals with needs related to their religious observance or practice.
About The Team
Piramal Critical Care (PCC), under Piramal Pharma Limited (PPL), a subsidiary of Piramal Enterprises Limited, is the third largest producer of Inhaled Anaesthetics and a global player in hospital generics. Motivated by its vision to deliver critical care solutions for patients and healthcare providers across the globe, PCC is committed to enabling sustainable and profitable growth for all its stakeholders.PCC maintains a wide presence across the USA, Europe and more than 100 countries across the globe. Its rich product portfolio includes Inhalation Anaesthetics such as Sevoflurane, Isoflurane and Halothane as well as Intrathecal Baclofen therapy, for spasticity management. PCC has wholly-owned, state-of-the-art manufacturing facilities in the US and India that have successfully cleared periodical inspections by the US FDA, UK MHRA and other regulators.Its core strength lies in a highly qualified global workforce of more than 400 employees across 16 countries. PCC is focused on further expanding its global footprint through new product additions in the critical care space.Committed to corporate social responsibility alongside Piramal Group, PCC collaborates with various partner organizations and proudly takes an active role in providing hope and resources to those in need, as well as caring for the environment.
