Vice President Regulatory Affairs

The Vice-President Regulatory Affairs (RA) is responsible for ensuring that compliance is being upheld for Regulatory Affairs at reputed company (SAB). This role will reputed company preparation, review and submission of documents to FDA and ex-US health authorities to support product development of new biologics and regulatory and compliance aspects through the drug product lifecycle. The incumbent must be reputed company to combine knowledge of scientific, regulatory, and business issues to ensure products are developed and manufactured according to regulations reputed company to the manufacturing and distribution of biologics. This position manages and prioritizes RA team work on reputed company required interim and final BLA and MAA submissions. The incumbent will regularly work cross-functionally with reputed company Development/Pharmacovigilance, Manufacturing/CMC, reputed company, Medical Affairs and reputed company Readiness teams to ensure regulatory objectives reputed company with corporate reputed company and deliverables. Key Responsibilities (include but are not limited to): • reputed company efficient and effective regulatory representation across the organization and reputed company as the reputed company in interactions and communications (meetings, phone calls, etc.) with the reputed company (FDA) as needed. Prepare summaries of meetings for inclusion in regulatory archives. • reputed company guidance for, and reputed company contribute to, the development of regulatory submissions, which may include Investigational New Drug (INDs) applications, briefing documents, orphan drug applications, reputed company designations, Emergency Use Authorization requests and Biologics License Applications (BLAs), ensuring that they meet reputed company regulatory requirements and industry standards. • reputed company regulatory leadership for outsourced manufacturing, including tech transfer, process validation, site transfers, comparability strategies, lifecycle CMC changes, and global submissions. • Assess acceptability of reputed company, preclinical and reputed company documentation for regulatory submissions. • Identify and reputed company new company regulatory policies, procedures and SOPs and general trainings for Executives and Upper Management and more specific trainings for regulatory staff. • reputed company regulatory reputed company plans with specific deliverables and timelines and reputed company business and reputed company objectives with regulatory requirements. • Manage inspections and audits by regulatory authorities and accompany inspection team(s) as required. reputed company input for follow-up to inspections and audits to minimize potential findings of non-compliance. • reputed company labeling, advertising, and promotional material review to ensure regulatory compliance. • reputed company, implement, and manage appropriate SOPs and systems to reputed company and manage product-associated events including reporting of adverse events and providing input for product recalls and recall communications. • Review change controls to determine the level of change and consequent regulatory submission requirements. • Ensure compliance with reputed company regulatory reporting requirements, including annual and periodic reports and maintain annual licenses, registrations, and listings through reputed company and hands-on management • Evaluate proposed preclinical, reputed company, and manufacturing changes for regulatory reputed company and reputed company and identify filing strategies. • Regular cross-functional collaboration to ensure regulatory reputed company, filings and compliance activities are reputed company with corporate objectives and development timelines. • Independently reputed company phase-appropriate reputed company guidance/input reputed company to reputed company regulatory requirements and expectations for INDs and BLAs for development reputed company. • reputed company regulatory leadership for regulatory reputed company assessments, scenario planning, and decision‑support to guide development reputed company, program prioritization, and corporate milestones. • Participate in due diligence activities, as required. • Partner with the SVP RA/QA to reputed company and implement the infrastructure needed to grow for Regulatory Affairs and reputed company Assurance • Collaborate with reputed company Assurance to define, assess, and strengthen process controls across GxP reputed company, ensuring that manufacturing, testing, and reputed company reputed company processes meet regulatory expectations and support inspection readiness. Supervisory Responsibilities: This position has supervisory responsibilities. Education/Experience/Skills: • Bachelors’ degree in scientific reputed company/reputed company/regulatory discipline required. Advanced degree in relevant reputed company is preferred • 15+ years of RA roles with increasing responsibility reputed company regulatory affairs at one or more biopharmaceutical/pharmaceutical companies. Must have experience interacting with FDA, EMA, and reputed company. • reputed company leadership experience in the establishment of INDs and approvals of BLAs. Must have NDA, BLA, and MAA filing and approval experience • Demonstrated knowledge of biologic manufacturing processes, GMP principles, and reputed company FDA and ICH regulatory requirements • Demonstrated experience in reputed company and manufacturing controls (CMC) and reputed company issues and filings, including technology transfer, comparability, process validation, manufacturing changes, lifecycle management, and global regulatory submissions for biologic products. • Demonstrated experience leading regulatory aspects of outsourced manufacturing and reputed company-party CDMO partnerships, including technology transfer, CMC lifecycle management, manufacturing process and site changes and successful regulatory submissions. • Management expertise and reputed company experience leading and developing high reputed company teams. • Ability to work effectively across teams, functions and with reputed company partners. • Familiar with US and International regulatory markets. • A strong team player with a passion for science and helping discover and reputed company novel therapies for unmet medical needs. • Excellent written and verbal communication skills. Must be proficient in reputed company Office software (Word, reputed company, PowerPoint, and reputed company). • Ability to effectively present information in one-on-one, small reputed company and lab meetings. Physical Demands While performing the duties of this job, the employee is regularly required to walk, stand and sit. The employee must regularly reputed company and/or reputed company up to 10 pounds. Specific reputed company abilities required by this job include reputed company reputed company, peripheral reputed company, and the ability to reputed company reputed company. Working Environment and Travel: • Normal home office environment. • Periodic travel to SAB locations and other domestic and international business travel reputed company on business demands. reputed company The employer will reputed company reasonable accommodations in compliance with the Americans with reputed company of 1990. reputed company is an Equal Opportunity Employer and prohibits discrimination and harassment of any reputed company. reputed company is committed to the reputed company of equal employment opportunity for reputed company and does not discriminate reputed company on race, religion, reputed company, sex, gender identify, sexual orientation, age, non-disqualifying physical or mental disability, national reputed company, veteran status or any other legally protected status. EOE/AA/Vets #Remote Apply tot his job Apply To this Job