Senior Consultant at Freelancing
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Director - Global Regulatory Affairs - Oncology - Pharma (9-15 yrs)
Director Global Regulatory Affairs-Oncology
- Serve as an empowered Regional or Global Regulatory Lead for the asset/group of assets for the Therapeutic Group(s); key point of contact on the Medicine Development Team and within GRA;
- Provides counsel and interpretation of health authority feedback, guidelines and policy to project team for assigned asset in alignment within global regulatory affairs;
- Participates in the design and interpretation of results from medicines development program;
- Integrate all aspects of strategic & operational regulatory input to asset development in conjunction with clinical, technical, clinical pharmacology, biostatistics, non-clinical, biomarker/pharmacogenomics and diagnostic/device stakeholders as appropriate
- Provides regulatory due diligence into business opportunities as needed;
- Develop the asset specific regional and/or global regulatory strategy, including ownership and accountability as needed;
- Input to Medicine Development Strategy and Commercialization strategy in order to optimise the label and ensure alignment with business objectives;
- Lead preparations and delivery of Health Authority Interactions with asset Medicine Development Team for regional/global Health Authority interactions
- Drive or support efforts to shape the regulatory environment
- Point of contact for Regulatory Agencies for asset (or oversight/support to regional points of contact to authorities)
- Responsible for keeping management team informed of regulatory status of projects and any risks/issues;
- Anticipate and plan for changes in the evolving regulatory environment and policy/regulations; develop and implement risk mitigation strategies as appropriate
- Lead regional and/or global filings with high quality and expedited fashion. Do this in alignment with regulatory, development and commercialization strategy to optimize the value of our medicines to patients, payors and the business. Develop, review and complete submission documents in collaboration with other functional disciplines. Achieve this in a collaborative and trusting relationship with regulators and other external stakeholders.
- Deliver all maintenance related activities for the asset in compliance with COMPANY policies/procedures and regulations
- Operate with strong global teamwork with the Regulatory Matrix Team and Medicine Development Team
- Advanced Scientific Degree (MS, Pharma D, Ph.D.)
- Strong leadership capabilities and ability to think strategically
- Significant regulatory experience in development and life-cycle management; experience in Oncology a must.
- Demonstrated track record of working in a global team and matrix organization.
- Evidence of building trust with key stakeholders and operating with an enterprise approach.
- Significant experience integrating regulatory science with general scientific knowledge and business acumen.
- Direct experience in the development of medicinal products, health authority interactions and obtaining licenses in different geographic areas.
Preferred Qualifications :
- Strong written and verbal communications skills
- Strong negotiation skills across levels within an organization and with external stakeholders
- Strong ability to influence and drive change
- Strong ability to manage multiple projects and proactively plan
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