Berufsbezeichnung: Director – PPG R&D

Arbeitsbeschreibung:
The Director PPG R &D and Product development is responsible for overseeing both the strategic and operational aspects of the regulatory objectives for all R&D projects and commercial products in Dermatology, Neurology and Paediatric Franchises within the organization, including leading scientific/strategic meetings with various regulatory agencies in EU, US and in India, the timing/sequencing of regulatory milestones as well as the preparation, review and evaluation of documents for submission to health care regulatory authorities. The ideal candidate would be the strategic and operational leader within the pharmaceutical organization, utilizing their advanced analytical, strategic, interpersonal and communication skills to propel the team forward. Job Description 1. Formulate and oversee the execution of strategies for development of differentiated formulations and NCEs of early stage and late stage projects through CTA/IND filing for clinical trials to achieve organization’s short term and long term goals 2. Playing the role of Project champion/leader and taking decisions connected all developmental activities of the programs such as Pre-clinical, clinical development to ensure timely progression of the R&D programs. 3. Coordinating with Internal and external team for various other functions connected with the program/product development. 4. Coordinating with CRO/CMOs to ensure manufacturing supplies as needed 5. Representing project committees, joint steering committees of all collaborated projects with external partners 6. Responsible for monitoring and managing project budgets and financials connected with the project 7. Organize and lead scientific meetings with regulatory agencies in EU to discuss about strategies for development and registration pathways for differentiated formulations of early stage and late stage projects in Dermatology, Neurology and Paediatric Franchises 8. Organize, participate and interact with agencies during PIND/EOP1/EOP2/Pre-NDA meetings with FDA to discuss about strategies for development and registration pathways for differentiated formulations of Early Stage and Late Stage Projects in Dermatology, Neurology and Paediatric Franchises 9. Devise new regulatory CMC strategies in support of development programs; investigational and commercial drug products 10. Oversee the activities for CTD dossier preparation activities such as nonclinical, clinical, CMC and regulatory modules including reports, perform the gap analysis of dossiers for assessing regulatory compliance and ensure timely submission of MAA/NDA to the Agencies 11. Lead and manage the constructive interactions with project team members, consultants, contractors and regulatory agencies to ensure all project/programs have clearly defined regulatory paths and milestones leading to successful filings and approvals. 12. Work collaboratively across functions and teams to develop and implement the Company’s regulatory strategies and respond to health agencies, as needed to get timely approval of MAA/NDAs. 13. Lead the regulatory team efforts in PP business unit and collaborate with EMIN-DF group for defining regulatory strategies for development and registration of differentiated formulations in emerging market including India. 14. Provide regulatory leadership and serves as an integral member of the due diligence team to assess potential licensing and product acquisition opportunities 15. In conjunction with project/program team leaders, ensures budgetary and operational goals are met. 16. Define and track regulatory deliverables from external service providers (CROs); perform due diligence of service providers and partners as required, review and manage service provider's/partners budget and ensure quality of deliverables to support regulatory submissions 17. Develop a motivated regulatory team, manage people and ensure quality systems including SOPs within department to ensure smooth function of department and regulator

Angestelltenname: Dr. Reddy's Laboratories SA

Arbeitgeber-Adresse:
Dr. Reddy's Laboratories SA Elisabethenanlage 11 4051 Basel

Form von Kontakt: Vishwas Muthyala

Arbeitgeber Telefonnummer: +41 61 561 6800

Stellenkurzbeschreibung: Akademische Berufe

Land: Schweiz

Region: Basel-Stadt

Vertragslaufzeit: Unbefristet

Vertragstyp: Vollzeit

Erforderliche Ausbildung: Keine Angabe

Erfahrung: 5 Jahre und mehr

Quelle des Stellenangebots:
SECO,Öffentliche Arbeitsverwaltungen, Schweiz (Confoederatio Helvetica)

Fahrerlaubnis: Nein

Wie Sie sich bewerben: Weitere Angaben (siehe Beschreibung)

Gehalt Währung: CHF

Gehaltsperiode: Gehalt Periode nicht spezifiziert

Gehalt Besteuerung: brutto