| onlly w2 and usc need submissions for Regulatory Affairs Strategy Contractor, Cambridge, MA at Cambridge, New York, USA |
| Email: [email protected] |
| From: Uma, nukasanigroup [email protected] Reply to: [email protected] Dear Partner, Good Morning , Greetings from Nukasani group Inc !, We have below urgent contract project immediately available, could you please review the below very long term role, Regulatory Affairs Strategy Contractor, Cambridge, MA, if you are available, could you please send me updated word resume, below candidate submission format details immediately. If you are not available, any referrals would be greatly appreciated. Interviews are in progress, urgent response is appreciated. Looking forward for your immediate response and working with you. **Candidate Submission Format - needed from you** Full Legal Name Personal Cell No ( Not google phone number) Email Id Skype Id Interview Availability Availability to start, if selected Current Location Open to Relocate Work Authorization Total Relevant Experience Education./ Year of graduation University Name, Location Country of Birth Contractor Type Home Zip Code **Assigned Job Details** Job Title : Regulatory Affairs Strategy Contractor Location: Cambridge, MA **JOB DESCRIPTION:** Lead the preparation of regulatory submissions to assure full compliance with all relevant requirements in the U.S. as well as in Europe, Canada, Japan and Australia. Provide strategic and operational input, guidance and oversight to global project teams to assure that regulatory submissions and all aspects of regulatory compliance support R&D objectives. Develop and create regulatory compliance strategies for multiple clinical development projects. Coordinate all aspects of the preparation, review and submission of regulatory documents. This includes the clinical and non-clinical portions of documents. Represent the Regulatory Affairs Department as a member of cross functional project teams and provide guidance relating to changing global regulatory requirements. Serve as the Companys Regulatory Affairs Lead in interactions with global health authorities including the FDA, EMA, MHRA, Health Canada and ROW with respect to clinical submission documents. Provide leadership and direction in the development of clinical regulatory documents including INDs, CTAs, BLAs, DMFs, NDAs and MAAs. Make submissions to global regulatory authorities, as required, and maintain an ongoing interactive relationship regarding these submissions. Coordinate and maintain reporting schedules for regulatory applications. Assure that all aspects of the Companys regulatory activities are conducted in full compliance with applicable regulations and at the highest level of ethical standards. Create and maintain Regulatory Strategic Development plans and provide strategic input in global product development planning. Identify and communicate to executive management information about potential regulatory issues; propose risk evaluations and mitigation strategies. Mentor and help develop the strategic & technical expertise of regulatory colleagues who are involved in supporting filings. Perform other duties as assigned. Understanding of global regulatory submissions including compliance with FDA, EMA, ICH and ROW clinical and preclinical regulatory requirements. Relevant filing experience (INDs and NDAs) in leading negotiations and Health Authority interactions as well as FDA Advisory Committee Meetings (e.g. ODAC). Experience with regulatory filings in oncology is preferred. Strong written and oral communication skills and the ability to interact effectively with project teams. Ability to manage regulatory affairs activities and provide leadership in a hands-on fashion while utilizing a strategic approach in all aspects of global compliance. Bachelors degree in a relevant scientific discipline. Masters or an advanced degree (PhD, PharmD) is preferred. 10-15 years of regulatory affairs experience in the pharmaceutical industry. **Skills Required:** CLINICAL REGULATORY FDA FILING FILINGS ICH **Additional:** ONCOLOGY PRECLINICAL REGULATORY AFFAIRS REGULATORY COMPLIANCE REGULATORY DOCUMENTS MENTOR MITIGATION PHARMD PRODUCT DEVELOPMENT < **Languages:English** Minimum Degree Required:Bachelor's Degree Also Preferred: Thanks and Regards Uma| Talent acquisition| Nukasani Group | 1001 E Chicago Ave, Unit B 111, Naperville IL 60540. Email: [email protected]| Direct: |630 345 4732| People, Process, Technology Integrator. An E-Verified Company. |
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| Tue Oct 18 18:19:00 UTC 2022 |