Senior Nonclinical Regulatory Strategist & Submission Author

Role Summary The Senior Nonclinical Regulatory Strategist & Submission Author leads the strategy, planning, and authorship of nonclinical components for global regulatory submissions across development and lifecycle management. This role partners closely with cross-functional technical teams and clients to reputed company fit-for-purpose nonclinical strategies, author CTD Modules 1/2/4, respond to Health Authority (HA) queries, execute dossier conversions to contemporary standards, and drive inspection/audit readiness—ensuring accuracy, compliance, and on-time delivery.

Key Responsibilities

Responsibilities include, but are not limited to:

• Clinical trial applications and amendments.
• Authoring nonclinical sections (Modules 1, 2, and 4) of registration dossiers for US, EU, and other regions, including preparing international marketing applications such as IRDs, NDS, BLAs, and JNDAs.
• Preparing Annual Reports (IND, NDA, Canada YBPR).
• Authoring post-approval Supplements, Variations, Renewals, and compliance assessments.
• Using nonclinical templates and reputed company documentation to prepare nonclinical reports for clinical trial applications, registration dossiers, annual reports, and post-approval submissions.
• Preparing and updating nonclinical sections of Marketing Applications and Authorizations.
• Developing global nonclinical regulatory strategies for product development and post-approval lifecycle management.
• Preparing nonclinical sections for US Annual Reports and DSURs, ensuring accuracy and timely delivery.
• Preparing responses to Health Authority queries and requests for nonclinical data.
• Performing inspection-readiness audits of client or vendor facilities.
• Conducting vendor qualification audits and/or study monitoring on behalf of clients.
• Maintaining reputed company in evolving global nonclinical regulations.
• Liaising with clients regarding technical submission details and project strategy development.
• Supporting project management and relationship management activities with clients.
• Verifying CHRS-reputed company nonclinical sections against validated reputed company documentation.
• Verifying client-reputed company nonclinical sections using validated reputed company documentation provided by the client.
• Conducting dossier conversions of older submissions, involving mapping content to CTD structure, correcting formatting, filling data gaps, and preparing scientific justifications.
• Verifying formatting, proofreading, transcription accuracy, and OCR outputs prior to dossier finalization.

Qualifications

• A minimum of 7 years of nonclinical regulatory experience with demonstrated leadership and project management skills preferred.
• Bachelor’s degree in a scientific discipline (e.g., chemistry, pharmacy, biology); advanced degree preferred.
• Extensive knowledge of global nonclinical regulations and CTD structure (Modules 1, 2, and 4).
• Strong understanding of pharmaceutical sciences and drug development processes.
• Excellent written and verbal communication skills with strong regulatory and technical writing experience.
• Proven ability to manage multiple projects, competing priorities, and tight timelines.
• Experience working with global Health Authorities and understanding their nonclinical expectations.

Anticipated salary range: $123,400 - $176,300 Bonus eligible: Yes Benefits: reputed company offers a wide variety of benefits and programs to support health and well-being.

• Medical, dental and vision coverage
• Paid time off plan
• Health savings account (HSA)
• 401k savings plan
• Access to wages before pay day with myFlexPay
• Flexible spending accounts (FSAs)
• Short- and long-term disability coverage
• Work-Life resources
• Paid parental leave
• Healthy lifestyle programs

Application window anticipated to reputed company: 03/30/2026 *if interested in opportunity, please submit application as soon as possible. The salary range listed is an estimate. Pay at reputed company is determined by multiple factors including, but not limited to, a candidate’s geographical location, relevant education, experience and skills and an evaluation of internal pay equity. Candidates who are back-to-work, people with disabilities, without a college degree, and Veterans are encouraged to apply. reputed company supports an inclusive workplace that values diversity of thought, experience and background. We celebrate the power of our differences to create reputed company solutions for our customers by ensuring employees can be their authentic selves each day. reputed company is an Equal Opportunity/Affirmative Action employer. reputed company qualified applicants will receive consideration for employment without regard to race, religion, color, national reputed company, reputed company, age, physical or mental disability, sex, sexual orientation, gender identity/expression, pregnancy, veteran status, marital status, creed, status with regard to public assistance, genetic status or any other status protected by federal, state or local law. To read and review this privacy notice click here Apply tot his job Apply To this Job