Executive Director, Regulatory Affairs

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Company :
Net2Source inc

Location :
Bridgewater, New Jersey

Expiry Date :
Sun, 06 Dec 2020 23:59:59 GMT

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Description :
Net2Source is a Global Workforce Solutions Company headquartered at NJ, USA with its branch offices in Asia Pacific Region. We are one of the fastest growing IT Consulting company across the USA and we_are_hiring_"Executive Director,_Regulatory_Affairs"_for_one_of_our_clients. We offer a wide gamut of consulting solutions customized to our 450+ clients ranging from Fortune 500/ 1000 to Start-ups across various verticals like Technology, Financial Services, Healthcare, Life Sciences, Oil & Gas, Energy, Retail, Telecom, Utilities, Technology, Manufacturing, the Internet, and Engineering. Position: Executive Director, Regulatory Affairs Location: Bridgewater, NJ (Remote till Pandemic) Duration: Full Time Position Description: Need experience leading regulatory authority interactions, both in the US and global. Overall responsibility for providing regulatory oversight & strategic technical regulatory input to cross-functional project teams for all project activities. Defines and implements global regulatory strategies, ensuring that all regulatory requirements/commitments are met with respect to regulatory submissions for INDs, IMPDs, CTAs, MAAs, JNDAs, NDAs and other regional submissions. This is a supervisory position This role oversees vendors and/or contractors Responsibilities Additional representative responsibilities will include, but not necessarily be limited to, the following: Formulate & implement Regulatory strategies and plans to achieve efficien & competitive product development Provide regulatory direction for the coordination, and preparation of regulatory submissions consistent with regulatory requirements to meet corporate strategy & timelines Provide regulatory input into cross-functional Project Teams for product development and submission activities Provide regulatory input into cross-functional Project Teams as required provide technical guidance & to assist in problem solving/issue resolution etc. Act as regulatory lead for the review of documentation prepared by other technical functions Provide regulatory review and approve of internal documentation supportin product development activities (e.g. clinical protocols, clinical study reports, statistical analysis plans, etc.) Responsible to lead essential Health Authority meetings, communications/ negotiations with Regulatory Agencies Primary contact for inquiries from Regulatory Agencies Monitor the development of new requirements or regulatory procedures Ensure on-time submission activities related to regulatory file maintenan (e.g. IND/CTA, information amendments, SAE reports, etc.) Coordinate with consultants and CROs assisting with submission activities including preparing electronic submission documents Creation and maintenance of regulatory project logs/databases, tracking t submission status of reports and other regulatory activities. Qualifications About You: Minimum 10 years Regulatory Affairs experience in the pharmaceutical or biotechnology required Bachelor’s degree (scientific or clinical background desirable) required; advanced degree preferred Must have experience with managing submissions supporting marketing authorization applications (e.g. NDA, MAA, JNDA) in electronic format (eCTD) submissions Experience in submission writing and review experience essential Experience with products with orphan drug status is highly preferred. Experience with inhalation products a plus Significant direct experience in dealing with FDA, EMA and other agency liaison activities Strong understanding of the drug development process. Excellent organizational, planning, and follow-up skills. Strong interpersonal skills Excellent communication skills (verbal and written) Must have ability to meet tight deadlines and be efficient, detail oriented, flexible, and a self-starter Highly organized with a strong attention to detail, clarity, accuracy and conciseness. Highly proficient in Microsoft Office (Word, Excel, PowerPoint, Outlook) and Adobe Acrobat. Must successfully exhibit five (5) core corporate values of: Respect, Passion Integrity, Collaboration, Accountability. Individuals must demonstrate the ability to interact successfully in a dynamic and culturally diverse workplace. Travel Requirements: Domestic and/or International travel required (less than 10%) is an Equal Opportunity Employer and will judge all applicants based on their qualifications for the job, without regard to race, color, sex, religion, national origin, age, disability or any other characteristics protected by applicable federal, state or local law. Unsolicited resumes from agencies should not be forwarded to. will not be responsible for any fees arising from the use of resumes through this source. will only pay a fee to agencies if a formal agreement between and the agency has been established. The Human Resources department is responsible for all recruitment activities; please contact us directly to be considered for a formal agreement. Please note that we review every submission and we will keep all submissions on file for six months. is an Equal Opportunity Employer. About Net2Source, Inc. Net2Source is an employer-of-choice for over 2200+ consultants across the globe. We recruit top-notch talent for over 40 Fortune and Government clients coast-to-coast across the U.S. We are one of the fastest-growing companies in the U.S. and this may be your opportunity to join us! Want to read more about Net2Source?, Visit us at Regards Kenneth Solomon Sr. Talent Scout Office: x 606 Email: Show moreShow less