Avantor, Inc. Regulatory Affairs Associate, Biopharma in Radnor, Pennsylvania
Job SummaryReports to the Director of Regulatory Affairs or designate. Assists in the management of the global regulatory aspects of new product development and supply chain distribution for biopharma products including active pharmaceutical ingredients and excipients with minimal direction from management. This position will prepare and submit documents necessary to gain US and foreign regulatory approval / clearance to place new or modified products into worldwide commercial distribution.
MAJOR JOB DUTIES AND RESPONSIBILITIES:
Compilation, maintenance, and submission of regulatory dossiers including Drug Master Files, Certificates of Suitability, and product registrations globally.
Prepare or direct the preparation of additional information or responses as requested by regulatory agencies.
Participation in design control, change control, and risk management multi-disciplinary teams.
Development of knowledge of and changes to global regulatory requirements and standards for the Pharmaceutical industry. Maintain current knowledge base of existing and emerging regulations, standards, or guidance documents.
Identify relevant guidance documents, international standards, or consensus standards and provide interpretive assistance.
Determine the types of regulatory submissions or internal documentation that are required to support proposed changes.
Applies for and maintain facility registrations, drug listings, federal and state licenses including Board of Pharmacy requirements.
Recommend changes to company procedures in response to changes in regulations or standards.
Prepare responses to customer requests for information, such as product data, written regulatory affairs statements, surveys, or questionnaires.
Other duties as assigned.
Bachelor’s Degree: Biology, Chemistry, Biochemistry, Biomedical Engineering, Legal Studies, Public Health Administration, Medical/Scientific Writing, or related is required. RAC or MS in Regulatory Sciences is desired.
1-2 years of experience working in regulated industry (pharmaceutical, or related) is desired.
Experience with domestic and international drug regulatory filings is highly desired.
Demonstrated understanding of Regulatory Affairs processes, both pre- and post-marketing is required.
Excellent verbal and written communication. Strong interpersonal skills, required to talk to customers, suppliers and fellow associates.
Attention to detail.
Working knowledge of 21 CFR 210/211, ICH Q7
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 all responsibilities, duties and skills required of employees assigned to this position.Avantor is proud to be an equal opportunity employer.
We are an Equal Employment/Affirmative Action employer. We do not discriminate in hiring on the basis of sex, gender identity, sexual orientation, race, color, religious creed, national origin, 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 TalentManagement@vwr.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 basis. Please note that only inquiries concerning a request for reasonable accommodation will be responded to from this email address.
Avantor® is a leading global provider of integrated, tailored solutions for the life sciences and advanced technology industries. Strengthened by the recent acquisition of VWR, the Company is a trusted partner to customers and suppliers from discovery to delivery. With operations in more than 30 countries and a diverse portfolio that includes more than four million products, Avantor enables customer success through innovation, cGMP manufacturing and comprehensive service offerings. Collectively, we set science in motion to create a better world.
Learn more at www.avantorsciences.com