1. To plan & manage entire product life cycle right from the product selection stage to the development and execution at manufacturing sites.
2. To work closely with Regulatory professionals to deliver quality post approval regulatory submissions in given timelines to support regulatory compliance.
3. To work closely with client for satisfactory quality of submission as per agreed timelines.
4. To effectively manage projects and associated complexities for Regulatory compliance and to apply correct prioritization in order to deliver the needs of business.
5. To facilitate in smooth functioning of client project through regular discussions, updates, involving all stakeholders and supervision for overall success of the project vertical.
6. To Prepare, track & control project budget and project schedule with respect to project plan baseline.
Salary: Not Disclosed by Recruiter
Industry:Pharma / Biotech / Clinical Research
Functional Area:Medical, Healthcare, R&D, Pharmaceuticals, Biotechnology
Role Category:Drug Regulatory Affairs/Documentation
Role:Regulatory Affairs Manager
Employment Type:Permanent Job, Full Time
Desired Candidate Profile
UG:B.Pharma - Pharmacy
PG:M.Pharma - Pharmacy
Gracure Pharmaceuticals Limited
We engage in the research, development, manufacturing, sourcing, marketing, and distribution of high-quality pharmaceutical products. We are a fully integrated company with in-house business development, R&D, manufacturing and regulatory compliance capabilities.
Gracure Pharmaceuticals is EU-GMP & TGA Australia approved manufacturing unit.
Our manufacturing capabilities include solid orals (coated tablets, uncoated tablets, hard gelatin capsules), liquids (syrup, suspension), dry syrups (dry powder syrups), external preparations (gels, creams, ointments).