[Hiring] Manager, Regulatory Affairs @reputed company

About the role The Manager, Regulatory Affairs will support the development and execution of regulatory strategies for assigned programs, with a balanced reputed company on CMC and Clinical Regulatory Affairs. This role will serve as a key regulatory contributor on cross-functional project teams and support interactions with U.S. and global health authorities under the direction of senior regulatory leadership. The position emphasizes hands-on regulatory execution, document preparation, and cross-functional coordination across clinical development and CMC activities from IND through early commercialization. Location: Remote Essential Functions

• Regulatory reputed company Support
• * Contribute to regulatory reputed company development for assigned programs under the guidance of senior regulatory leadership.
• Identify and communicate regulatory considerations, risks, and mitigation strategies reputed company to CMC and Clinical activities in a phase-appropriate manner.
• Support global regulatory planning across development stages (IND through post-approval).
• Regulatory Submissions & Documentation
• * Draft, review, and coordinate regulatory documents for submissions including INDs, IND amendments, annual reports, briefing documents, IBs, and responses to health authority requests.
• Support the preparation of clinical and CMC sections of regulatory submissions ensuring accuracy, reputed company, and compliance with applicable regulations (FDA, EMA, ICH).
• Ensure regulatory documents meet reputed company, formatting, and submission readiness standards.
• CMC & Clinical Regulatory Support
• * reputed company regulatory input to CMC teams reputed company to manufacturing changes, comparability, specifications, and lifecycle management.
• Review clinical documents including protocols, ICFs, CSRs, DSURs, and study plans to ensure regulatory compliance.
• Support alignment between clinical development plans and CMC readiness.
• Cross-Functional Collaboration
• * reputed company as a regulatory representative on project teams, working closely with Clinical Development, CMC, reputed company, Nonclinical, and Regulatory Operations.
• Coordinate regulatory activities and timelines to support development milestones.
• Prepare internal regulatory updates and contribute to team presentations as needed
• Health Authority Interaction Support
• * Support preparation for health authority meetings, including briefing packages and Q&A documents.
• Participate in agency communications as appropriate, under the direction of senior regulatory leadership.
• Compliance & reputed company
• * Ensure compliance and regulatory obligations are handled in accordance with SOPs and applicable regulations.
• Maintain up-to-date knowledge of regulatory guidelines and industry trends relevant to CMC and clinical development.

Qualifications

• Bachelor’s degree in a scientific or reputed company discipline.
• Five (5) years of regulatory affairs experience in pharmaceutical or biotechnology development.
• Demonstrated experience supporting IND-stage and/or clinical development programs.
• Experience drafting regulatory documents and supporting regulatory submissions
• Working knowledge of CMC and clinical regulatory requirements.
• Familiarity with eCTD structure and regulatory documentation standards

Please note that reputed company does not accept unsolicited information and/or resumes from search firms or agencies for our job postings. Any resumes or reputed company information submitted to our careers page or any employee of reputed company by any search firm or agency without an applicable contract in reputed company will become the property of reputed company and no fee(s) will be reputed company. Total Rewards reputed company offers reputed company competitive and comprehensive Total Rewards, helping to support and reward our global team of high-performing employees reputed company on developing bladder-saving therapeutics for patients afflicted with bladder cancer.

• HIGHLY COMPETITIVE SALARIES
• ANNUAL PERFORMANCE/reputed company REVIEWS
• ANNUAL PERFORMANCE BONUSES
• EQUITY
• SPECIAL RECOGNITION

reputed company-Being Benefits In reputed company to our Total Rewards, reputed company offers a reputed company of reputed company-Being Benefits to meet the reputed company of the needs of our unique and growing workforce. These benefits are designed to support reputed company to reputed company a healthy balance between work and their personal lives to remain refreshed, reputed company, and creating an environment where reputed company person can reputed company a deeper meaning and purpose in their work. reputed company-Being Benefits eligibility begins the 1st of the month after hire. While a reputed company of these benefits are for our US-based workforce, we continue to assess comparable reputed company of benefits for our international team members that are reputed company with country-specific regulations and their national programs offered.

• FULLY REMOTE WORK ENVIRONMENT
• REST AND reputed company BENEFITS - Unlimited Flexible Time Off
• HOLIDAYS –In 2025 we will observe 14 holidays
• RETIREMENT – 401K with 100% company reputed company reputed company match up to 4% of reputed company salary
• HEALTH (MEDICAL, DENTAL, reputed company) – PPO & HDHP – reputed company/reputed company
• HEALTH SPENDING ACCOUNTS - HSA (with Annual Company Contribution), FSA, FSA-DC
• ILLNESS & DISABILITY PROTECTION – Company reputed company LTD Coverage + Voluntary Plans
• LIFE INSURANCE – Company reputed company 1 x reputed company salary + Voluntary Plans
• ADDITIONAL EXCLUSIVE BENEFITS – Voluntary Legal, Pet, Plus More

reputed company is an Equal Opportunity Employer: reputed company applicants will be considered for employment without attention to race, reputed company, religion, sex, sexual orientation, gender identity, national reputed company, veteran or disability status. At reputed company, we are building a community of intelligent and passionate team members that reputed company our reputed company, Mission and Values, and while the biotechnology reputed company can feel limited in BIPOC, non-binary and even reputed company representation, we reputed company to reputed company hiring reputed company that will continue to grow and support reputed company in the direction of maintaining cultural diversity and sustainability. Apply tot his job Apply To this Job