| Regulatory Studio - Global or US Regulatory Strategist at Remote, Remote, USA |
| Email: [email protected] |
| From: Deepika Dua, Stellar Consulting Solutions LLC [email protected] Reply to: [email protected] Hi , My name is Deepika & I am a recruiter at Stellar Consulting, and I came across your profile while looking for qualified candidates for a Regulatory Studio - Global or US Regulatory Strategist role. I was impressed by your experience and skills . I think you would be a great fit for this role, as you have almost all the skills & experience required for the role. Below are the job details for your reference. Job Title : Regulatory Studio - Global or US Regulatory Strategist Location : Remote Duration : Long Term Job Description: Lead and or/support the creation and approval of global regulatory plans in conjunction with Regulatory Leads Position Responsibilities In close partnership with the regional strategists / liaisons, develop strategic and operational plan for the development and the registration of assets across IN&F. Lead and/or support marketing application submission teams for indications that are at the regulatory filing stage; helping to develop strategy and content for global dossiers. Develop contingency plans for achieving regulatory objectives with associated risks and mitigation strategies in conjunction with GRST. Propose approaches to resolve regulatory issues and appropriately drive speed to patients. Lead and/or support global health authority interactions by preparing objectives for meetings, outline of briefing material, facilitating content discussions and input. Contribute to building a strong and trusted relationship with Health Authorities. Lead the preparation of, and contribute to, the content of responses to queries from HAs for respective regions/countries Provide input to key development documents, including clinical protocols, clinical and nonclinical reports and summary documents, statistical analysis plans, DMC charters, IBs, DSURs; (US Regulatory documents such as BTD, ODD, iPSP) etc. Understanding of scientific content, drug development and regulatory requirements. Participate in the assessment of regulatory precedent and regulatory scientific guidelines. Lead identification and compilation of regulatory lessons learned, bringing the appropriate regulatory and clinical experts together, e.g. registrational program precedents, integrated summaries of EPARs and SBOA, main messages from a competitor AdCom. Track schedules and attendance of relevant Public-Private regulatory meetings or FDA workshops. Contribute to one regulatory voice to key stakeholders internally and externally (operational partners, health authorities). Facilitate identification of and internal agreement on target labeling Degree / Experience Requirements Scientific background, Ph.D., M.D., PharmD, MS or BS, or equivalent professional experience At least 2-4 years of relevant regulatory experience or 4-8 years pharmaceutical industry experience. Additional Requirements A basic knowledge of (i) drug development and (ii) policy, laws, regulations and guidelines as they apply to the FDA for drug development and approval is required. Good interpersonal skills; willingness to leverage strengths of the team and cooperate with peers within in a cross-functional environment. Proven ability to work with outside partners. Demonstrated ability to be solution-oriented Seeks multiple perspectives and listens openly to others points of views. Enables and demonstrates the courage to speak up on issues and risks as well as on the good news. Demonstrates ownership of results within (and beyond) area of responsibility. Sets clear and high expectations and holds self and others accountable for decisions and results achieved. Looks for opportunities for continuous improvement. If you be interested, please send me a copy of your resume in word format along with the following details ASAP. Full Name: Current Location: Hourly rate on C2C/W2: Work Authorization: Earliest Available date to start: Date and times available to interview: Two Professional References:(Preferably Supervisory references): Deepika Dua Sr. Technical Recruiter at Stellar Consulting Solutions, LLC Phone : +1 678-935-7075 : [email protected] : https://www.linkedin.com/in/deepika-dua-018459166/ Keywords: access management wtwo microsoft Regulatory Studio - Global or US Regulatory Strategist [email protected] |
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| Sat Sep 14 05:13:00 UTC 2024 |