Regulatory Affairs Specialist II

Review and assess design and CMC changes, and prepare suitable submissions to ensure compliance to pharmaceutical regulatory requirements. Support and provide regulatory input for pharmaceutical quality system deliverables such as batch variation summaries, customer complaints, CAPA, deviations, NCMR, etc. for the manufacturing site(s). Prepare and submit OPDP, NDA and IND submissions and annual reports using eGateway via third party providers for USA submissions. Support clinical, sustaining projects and other product focused teams by giving direction on regulatory impact and requirements for proposed changes. Establish and maintain effective relationships and professional interactions with manufacturing sites CMC and Quality staff, third party suppliers, regulatory authority staff and reviewers. Support filings and maintenance of regulatory files globally. Management of local site licenses for manufacture and importation. Participate in regulatory authority inspections and audits. Monitor regulatory landscape and communicate changes or new requirements that may impact the product or quality system. Degree in Life sciences (e.g., Chemistry, Biology, etc.). Minimum requirement of pharma industry experience 1-3years, ideally in a regulatory capicity. Medical device regulatory experience desirable. Demonstrated leadership and organizational skills. Understanding of commercial business. Demonstrated ability to handle multiple projects. Working knowledge of local regulations and guidelines related to drug development and registration. Excellent verbal and written communication skills. Work successfully within a team environment and as an individual contributor. Flexible and ability to adapt to changing regulatory environment and business needs. Proficient use of technology including MS office programs and Internet resources.