The Director US Regulatory Affairs is responsible for managing, designing and implementing the U.S. regulatory strategy as part of a global development group. This Directors goal will be the successful development of clinical-stage programs for Shionogis pipeline products -- while also offering guidance on ex-US regulatory strategy and filings.
Direct and coordinate activities of assigned products within Regulatory Affairs encompassing developmental products and post-marketing commitments.
Function as the primary contact for negotiations and interactions with the FDA and offer guidance and strategy to ex-US strategy and filings.
Contribute to developing regulatory strategies to ensure the shortest FDA review and approval times for regulatory applications.
Provide regulatory guidance to team during strategy formulation and submission preparation.
Coordinate and consult with other departments on the content, review, and assembly of regulatory documentation. Ensure consistency, completeness, and adherence to FDA standards for all regulatory submissions.
Author (when applicable) and maintain IND and NDA applications, supplements and annual reports pertaining to on-going application maintenance in accordance with established timelines and submission dates.
Liaise with regulatory agencies on product-related regulatory issues. Schedule, participate in, and prepare briefing documents for face-to-face meetings and teleconferences with health authorities.
Critically review protocols, data and reports to ensure the clarity, consistency, and conformance to regulations, guidelines and regulatory strategy as well as suitability for submission to regulatory agencies.
Assist with departmental policy and procedure development and implementation. Ensure adherence to Company Standard Operating Procedures. Review and assess Companys change controls with respect to regulatory requirements.
Prepare and submit reports to senior management, as required.
Offer regulatory evaluation and opinions on due diligence activities and provide regulatory assessment to management.
Will supervise lower level staff.
M.S. degree in a life science or other relevant discipline; advanced degree is preferred.
9 years of relevant experience in drug or biologics development.
Recent responsibilities within the infectious disease, respiratory, GI and/or pain therapeutic areas is a plus.
Direct CDER experience preferred; RAC certification preferred.
Thorough knowledge of FDA and ex-US requirements.
Proven record in effectively managing multiple projects/activities and working in a team-oriented environment.
Direct experience with successful NDA submissions.
Energetic, results oriented individual contributor and team player.
Ability to effectively communicate with employees at all levels using strong verbal and written communications skills; ability to articulate clearly and conduct verbal presentations with large and small audiences.
Must have strong analytical and technical writing skills.
Thorough knowledge and understanding of Food and Drug Administration and ICH guidelines required.
Ability to effectively organize and prioritize tasks to achieve established deadlines.
Ability and willingness to travel domestically and internationally up to 20% of the year; ability to travel via automobile, train, and/or airplane.
Experience with eCTD submission software useful, but not required.
Hybrid work arrangements will allow work from home combined with your presence on-site at our US HQ in Florham Park, NJ.
To be considered for this position, you must apply and meet the requirements of this opportunity.
We look forward to reviewing your resume & qualifications.
Please be aware that Shionogi Inc. mandates COVID-19 vaccination of all employees and contractors regardless of work location. Accommodations may be made in accordance with applicable law.
The job description is not designed to cover or contain a comprehensive listing of requirements, duties or responsibilities that are required of the employee. Other requirements, duties and responsibilitiesmay change or be assigned at any time with or without notice.
Shionogi Inc. is an equal opportunity/affirmative action employer.
All qualified applicants will receive equal consideration for employment opportunities based on valid job requirements without regard to race, color, religion, sex (including pregnancy), sexual orientation, gender identity, marital status, national origin, age, ancestry, citizenship, disability, genetic information, status as a disabled veteran, a recently separated veteran, Active Duty Wartime or Campaign Badge Veterans, and Armed Forces Service Medal Veterans, or any other characteristic protected by applicable law.
It is the policy of Shionogi Inc. to undertake affirmative action in compliance with all federal, state, and local requirements to recruit a diverse pool of applicants and to ensure that our employment practices are, in fact, non-discriminatory.
Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance...
Equal Opportunity Employer - minorities/females/veterans/individuals with disabilities/sexual orientation/gender identity