Senior Regulatory Affairs Specialist

Job Description

Job Description Job ID: LIF004430
About Us

Find what drives you on a team with a 70+ year history of being recognized for discovery, determination, and innovation. As a global leader in high-tech filtration, separation, and purification, Pall Corporation thrives on helping our customers protect people. Our portfolio is broad, so if your interests lie along the spectrum of Life Sciences to Industrial, you’ll find a rewarding role here. Our career opportunities are as diverse as our products and they are all focused on creating better lives and a better planet. At Pall, we believe that innovation is our legacy, our privilege, and our destiny. If that resonates with you, join us!

Description
Summary Of Position:

• Responsible for leading all aspects of the domestic and international registrations, supports regulatory submissions and maintains regulatory file documentation particularly for NDA and other 510k products released under CBER
• Meet objectives, goals and timelines as specified in Personal Development Plan.

Knowledge / skills / abilities

• Written and verbal skills must be excellent. Must be able to build clear, concise communications to regulators. Displays effective language and speaking skills to expertly and successfully communicate needs or requirements to others.
• Detail-oriented with a sense of urgency for completing projects on schedule.
• Must be able to analyze technical documents, policies, reports, scientific articles and research work to make informed decisions.

Main duties:

• Prepare the Quality Overall Summary and all eCTD module submission documentation for ANDA filings.
• Prepare responses to information requests, amendments, complete response letters, supplements, etc associated with ANDA submission and submit to FDA.
• Prepare annual reports and Field Alert Reports to align with 21 CFR 314.81
• Works with product development team and management to ensure continued regulatory support of marketed products.
• Lead all quality and regulatory aspects with the contract manufacturing that are: change control including manufacturing and QC process control, audit, investigation, review of stability data, labelling and any needed information to support the submission of annual report or other type of submission (PAS; CBE-30).
• Review documents and interact with multiple departments (QA, AS, Engineering, PD, etc.) which provide information and documentation to ensure accurate reporting to FDA.
• Maintain current knowledge of FDA regulations and guidance's pertaining to changes to approved ANDA regulatory applications. Prepare and submit changes to CBER on ANDA and other 510k products released under CBER.
• Track ANDA commitments made to FDA to ensure they are completed and reported in a timely manner. Maintain and ensure all confidential ANDA documentation is filed accurately.
• Host and coordinate audit with contract manufacturer with external regulatory authorities.
• Other duties as assigned.
• Must be prepared to work unsociable hours on infrequent occasion and be prepared to travel abroad.

Job Requirements
Qualifications
Basic Qualifications:

• Minimum of 6 years experience (minimum) working in regulatory affairs in domestic and international markets. Experience writing, evaluating and reviewing ANDAs required.
• Must have full knowledge of QMS and medical device regulatory requirements.
• Familiarity with drug CGMP (21 CFR Part 211) and application for FDA approval to market a new drug (21 CFR 314.81).
• Valid Driver's License
• Valid U.S. Passport

Preferred Qualifications:

• Candidate to be located in New York office. Reimbursement of moving fees to be figured out by the company.
• RAC (regulatory affairs certification) a plus.
• Experience working with the FDA is a plus.
• Computer and software proficiency, including Microsoft Office to build, edit and handle documents.

Pall is an equal opportunity employer. We evaluate qualified applicants without regard to race, color, national origin, religion, gender, age, marital status, disability, veteran status, sexual orientation, gender identity, or any other characteristic protected by law.

Diversity & InclusionAt Danaher, we are dedicated to building and sustaining a truly diverse and inclusive culture. These are not just words on a page—Diversity and Inclusion is a top priority for the company, and it ties deeply to each of our core values. Danaher Corporation and all Danaher Companies are equal opportunity employers that evaluate applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law.
Danaher Corporation Overview
Danaher is a global science & technology innovator committed to helping our customers solve complex challenges and improve quality of life worldwide. Our world class brands are leaders in some of the most demanding and attractive industries, including life sciences, medical diagnostics, environmental and applied solutions. Our globally diverse team of 71,000 associates is united by a common culture and operating system, the Danaher Business System, which serves as our competitive advantage. We generated $19.9B in revenue last year. We are ranked #162 on the Fortune 500 and our stock has outperformed the S&P 500 by more than 5,200% over 25 years. At Danaher, you can build a career in a way no other company can duplicate. Our brands allow us to offer dynamic careers across multiple industries. We're innovative, fast-paced, results-oriented, and we win. We need talented people to keep winning. Here you'll learn how DBS is used to shape strategy, focus execution, align our people, and create value for customers and shareholders. Come join our winning team. Danaher is committed to competitive compensation that typically has key components including base salary, variable annual incentive compensation based on personal and company performance, and long-term incentive.