Associate Director/Director of Regulatory Affairs, CMC & Regulatory Sciences will be responsible for providing regulatory guidance to (Bio)Pharma product development, especially biosimilars, preparing and reviewing submissions. S/he will work closely with cross-functional teams within the Company and across business partners, including development, regulatory, clinical and quality, as well as senior leadership team to develop regulatory strategies for both projects and portfolios in BioPharma, contributing to the transformation and growth of regulatory team to meet the needs of company's business growth toward biopharmaceuticals.
Essential Duties and Responsibilities include the following. Other duties may be assigned.
• Understand US regulatory guidance’s on biosimilars, track and interpret new guidance’s & new requirements for biosimilars, and assess their impact on the product development, including expertise, timeline and budgeting.
• Represent the regulatory function on cross-functional developmental teams for biosimilars, primarily with Operation, Quality, Legal and Marketing groups.
• Prepare, review meeting packages and submissions, including BIA, BPD, INDs, BLAs, etc.
• Serve as an interface with other regulatory groups in development, manufacturing, clinical partners, and consulting services.
• Lead preparation and management of meetings with health authorities, such as US FDA, EMA
• Contribute to the launch readiness and marketing by guiding the project team on the most appropriate regulatory approach from development through approval and provide post market support.
• Provide due diligence and review documents from global business partners for technical and regulatory compliance.
• Work with Head of Regulatory Affairs department to build up the competence and capacity for biosimilar and biologics.
• Provide training on CMC and regulatory sciences for biologics and biosimilar within RA department and cross-functions.
• Provide support to CMC and regulatory sciences of complex generics, especially peptide generics.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
EDUCATION AND/OR EXPERIENCE
Bachelor, Master, or Ph.D. 's degree in life sciences; over 8 years related experience in product development and/or regulatory CMC, with minimum of 3 years in biologics and/or biosimilars. Or equivalent combination of education and experience. Expertise in and experience with Regulatory Affairs of biosimilars are highly preferred.
Equal Opportunity Employer Minorities/Women/Veterans/Disabled.