| Global Regulatory Lead, Oncology, Global Regulatory Strategy & Policy-Remote at Remote, Remote, USA |
| Email: [email protected] |
| Hello Friends, I Hope you are doing well. This is Surya from Humac Inc. , Please check the following job description, and if you are interested, or know someone who might be interested, please share your updated resume to reach you. Role : Global Regulatory Lead, Oncology, Global Regulatory Strategy & Policy Location: Remote Client: Genpact Position Summary / Objective Develop global regulatory strategy for Oncology products in development and through life cycle management taking into account all relevant guidance, commercial needs, and company objectives. The Engagement Manager is located at Princeton Pike (PPK) so ideally, the candidate is local and can work a hybrid scheduled onsite at PPK. However the Engagement Manager will also consider candidates who are 100% remote in the US. Responsibilities Develop global or US regulatory strategy for Oncology products in development and through life cycle management, considering all relevant guidance, commercial needs, and company objectives. Develop strategic direction and provide leadership for all regulatory interactions with FDA/global regulatory authorities Lead regulatory dossier submissions to global and/or FDA (IND, BLA, NDA, and supplements) utilizing internal and external resources; ensure appropriate quality controls in place for compliant submissions Writing regulatory documents (e.g. new INDs, briefing book content, BT Designation request, Priority Review Requests, ODD); reviewing core documents to support IND/BLA/NDA, in conjunction with EUL or GRL as needed Provide strategic direction (and content input) on US Labeling Anticipate and interpret key trends and changes in the global/US regulatory environment and provide strategic guidance regarding development plans as a result. Foster positive relationships with FDA. Build and maintain a strong, collaborative relationship with all key stakeholders including Commercial, Medical Affairs, Promotion & Compliance, Global Development, and other functions key to the success of product development. Interact routinely and will develop a strong team environment with colleagues throughout GRS Education Requirements Ph.D., M.D., PharmD., MS or commensurate experience Experience Requirements: Significant experience in regulatory affairs (e.g., 3-5 years) -- Best Regards, Sai Surya Teja US IT Recruiter Humac Inc. P: (623)-748-4074 E: [email protected] | W: www.humacinc.com LinkedIn: linkedin.com/in/sai-surya-1b22a721b Phoenix, AZ 85027 Keywords: information technology microsoft Arizona Global Regulatory Lead, Oncology, Global Regulatory Strategy & Policy-Remote [email protected] |
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| Fri Sep 06 20:00:00 UTC 2024 |