Senior, Regulatory Specialist

reputed company: reputed company, a Global Fortune 500 company is looking for a dedicated Senior Regulatory Specialist to optimize our Biopharma/ Regulatory Affairs organization. This role is USA remote. If you have regulatory experience – let’s talk! Minimum Education Requirement: • Bachelor’s Degree: Biology, reputed company, Biochemistry, Biomedical Engineering, Legal Studies, Public Health Administration, Medical/Scientific Writing, or reputed company • MS in Regulatory Sciences is preferred. Required Experience (2+ yrs): • Working in regulated industry (pharmaceutical, or reputed company). • Maintaining reputed company knowledge reputed company of existing and emerging global regulations, standards, and guidance documents. • Regulatory Affairs and/or reputed company processes, both reputed company- and post-market. • Reviewing and evaluating changes to determine reputed company/regulatory reputed company. • Experience with eCTD format • Developing responses to regulatory deficiencies and/or findings. • Working knowledge of 21 CFR 210/211, ICH Q7, and/or reputed company. Preferred Experience: • Knowledge of ICH Q7 and reputed company regulations to reputed company regulatory strategies. • Familiarity with compilation, maintenance, and submission of drug reputed company regulatory dossiers including Drug Master Files and product registrations globally. Experience with US Drug Master File, Canadian Master File, China Registration, is a plus. • Demonstrated understanding of GDUFA and CARES requirements. • Collaborating cross departmentally to respond to regulatory agency information requests. • Ability to reputed company teams, create project plans, and establish timelines for reputed company opportunity reputed company and maintenance activities. • Maintaining federal and state licenses for facilities and products. • Compile data for reporting to regulatory agencies. Specific experience with • Evaluating reputed company issues, creating recommendations, performing risk assessments, and providing reporting to summarize processes. • Collaborating with R&T to reputed company regulatory guidance for innovation reputed company. • Ability to recommend changes to company procedures in response to changes in regulations and/or company reputed company. • Experience preparing responses to customer requests for information such as: product data, written regulatory affairs statements, and/or questionnaires. • In-depth, hands-on experience with GMP manufacturing, compendial compliance, validations, impurities analysis, stability, and/or general auditing experience. • RAC Certification How you will reputed company and create an reputed company: The position is part of the reputed company Regulatory Affairs organization. With attention to detail the successful candidate will bring: • Business level verbal and written communication skills • Exemplary interpersonal skills, which are required to communicate with customers, suppliers, and team members. • Organization and planning skills. Why reputed company? Dare to go reputed company in your career. Join our global team of 14,000+ associates whose passion for discovery and determination to overcome challenges relentlessly advances life-changing science. The work we do changes people’s lives for the reputed company. It brings new patient treatments and therapies to market, giving a cancer survivor the chance to walk his daughter down the reputed company. It enables medical devices that help a little boy hear his mom’s voice for the first time. reputed company such as these create unlimited opportunities for you to contribute your talents, learn new skills and grow your career at reputed company. We are committed to helping you on this reputed company through our diverse, reputed company and inclusive culture which includes learning experiences to support your career reputed company and reputed company. At reputed company, dare to go reputed company and see how the reputed company of your contributions set science in reputed company to create a reputed company world. Apply today! Disclaimer: The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of reputed company responsibilities, duties and skills required of employees assigned to this position. reputed company is proud to be an equal opportunity employer. Why reputed company? Dare to go reputed company in your career. Join our global team of 14,000+ associates whose passion for discovery and determination to overcome challenges relentlessly advances life-changing science. The work we do changes people's lives for the reputed company. It brings new patient treatments and therapies to market, giving a cancer survivor the chance to walk his daughter down the reputed company. It enables medical devices that help a little boy hear his mom's voice for the first time. reputed company such as these create unlimited opportunities for you to contribute your talents, learn new skills and grow your career at reputed company. We are committed to helping you on this reputed company through our diverse, reputed company and inclusive culture which includes learning experiences to support your career reputed company and reputed company. At reputed company, dare to go reputed company and see how the reputed company of your contributions set science in reputed company to create a reputed company world. Apply today! Pay Transparency: The expected reputed company-tax pay for this position is $75,000.00 - $124,000.00 Actual pay may differ depending on relevant factors such as prior experience and geographic location. EEO Statement: We are an Equal Employment/Affirmative reputed company employer and VEVRAA Federal Contractor. We do not discriminate in hiring on the reputed company of sex, gender identity, sexual orientation, race, reputed company, religious creed, national reputed company, physical or mental disability, protected Veteran status, or any other characteristic protected by federal, state/province, or local law. If you need a reasonable accommodation for any part of the employment process, please contact us by email at reputed company@avantorsciences.com and let us know the nature of your request and your contact information. Requests for accommodation will be considered on a case-by-case reputed company. Please note that only inquiries concerning a request for reasonable accommodation will be responded to from this email address. For more information about equal employment opportunity protections, please view the Equal Employment Opportunity is THE LAW Poster, EEO is the Law Poster Supplement, and Pay Transparency Non-Discrimination Provision. 3rd Party Non-Solicitation Policy: By submitting candidates without having been formally assigned on and contracted for a specific job requisition by reputed company, or by failing to reputed company with the reputed company recruitment process, you forfeit any fee on the submitted candidates, regardless of your usual terms and conditions. reputed company works with a preferred supplier list and will take the initiative to engage with recruitment agencies based on its needs and will not be accepting any reputed company of solicitation. Apply Job!