Greetings from Medreich (a Meiji Group Company)
We at Medreich are hiring Regulatory Affairs Professionals with 8-12 Years’ experience specific to the Australian and New Zealand markets
Key Responsibilities will include :
- Prepare, review, and submit new Marketing Authorization applications to the regulatory authorities of the TGA (Australia) and MEDSAFE (New Zealand).
- Prepare, review, and submit Post-Approval change/variation applications to the TGA (Australia) and MEDSAFE (New Zealand) regulatory authorities.
- Review Modules 1 to 5 and other supporting documents required for managing initial and Post-Approval change submissions.
- Address agency queries raised during initial and post-approval change applications by coordinating with cross-functional teams to ensure timely responses.
- Communicate with cross-functional teams (R&D, manufacturing, QA & QC, etc.) to gather all the required information to compile the dossier.
- Interact with R&D, manufacturing sites, packaging and development teams, quality control, quality assurance, pharmacovigilance, and the front-end office in Australia regarding Marketing Authorization topics for both initial and post-approval dossiers.
- Support the line manager in answering customer requests as needed.
- Communicate with the internal clinical team regarding BE study-related documents.
This role requires effective collaboration with various teams to ensure compliance and timely submission of all regulatory requirements.
The position is based in Bengaluru. Interested may please share the profiles to aravinda.p@medreich.com
Medreich is a fully integrated pharmaceutical company with an established presence across the globe. The company is involved in the CMO & CDMO business of pharmaceutical preparations in various dosage forms catering to diverse Therapeutic categories. Medreich has an advanced state of the art Research and Development centre with proven scientific competence to develop formulations as Patent Non-infringing and Niche generics in differentiated dosage form for global regulated markets.
Medreich has in house capability to ensure regulatory compliance in regulated markets across the globe. The company is manufacturing formulations in various dosage forms for MNC's like GSK, Pfizer, Sanofi, Novartis, Mylan, Apotex, iNova, Adcock Ingram and many other customers across 60 countries in key markets of UK, Europe, Australia , New Zealand, Canada, Japan, Far East Asia, GCC, Africa, LATAM and CIS. With more than 3000 employees worldwide, Medreich is providing a strong platform to its employees to learn, contribute and grow and is committed to providing quality medicines to patients world over to make their lives healthier. In the year 2015 Medreich achieved the transformational milestone in its 40 years of existence and became part of Meiji Group a leading Japanese conglomerate listed on Tokyo stock exchange and having business interests across the globe in Pharmaceuticals, food and nutrition products