Kowa Pharmaceuticals, Inc. maintains high ethical and professional standards and it all starts with people. This is why Kowa is pleased to announce the new position of Regulatory Affairs Manager and the opportunities it will provide. This position is located at the Kowa Pharmaceutical America, Inc. corporate office in Montgomery, Alabama. Applicants must reside within a reasonable distance of Montgomery, AL or be willing to relocate. Some relocation assistance may be provided. Please find more information about this exciting opportunity below.
The Regulatory Affairs Manager will support the regulatory affairs function by leading projects including regulatory submissions and communications.
Essential Job Functions:
Act as liaison to the FDA for regulatory projects, including acting as the designated US Agent in accordance with 21 CFR 207.69
Contribute to the development and implementation of regulatory strategies, processes, and procedures in a project team environment
Manage the preparation of regulatory submissions, including case report documents, in support of IND, NDA, BLA, ANDA
Manage regulatory activities and maintenance associated with assigned regulatory applications (e.g. IND, NDA) including planned submissions and annual reporting requirements
Submit promotional material to OPDP through eCTD;
Support the department in the preparation, coordination, and management of regulatory agency inspections, internal quality assurance audits, and in-licensing/out-licensing due diligence activities
Manage contracted organization responsible for electronic regulatory submissions;
Document regulatory authority communications
Assist in local (i.e. KPA) and global (i.e. KCL) SOP development and review, as requested
Participate in regulatory intelligence gathering activities and maintains knowledge of regulatory requirements
Responsible for all Regulatory Affairs record keeping
Act as a liaison between KPA and its affiliated companies in the USA, EU and Japan to ensure smooth communication
Display computer proficiency with Microsoft Word, Excel and PowerPoint
Excellent oral and written communications skills, excellent problem solving abilities, accurate data entry, and exceptional organizational skills
Comply with all company policies
Uphold organizational values
Performs other duties as assigned
NOTE: The information presented, while not an exact or exhaustive listing, describes the work, performance standards, and qualifications typically required of employees in this job.A specific position description or employee performance plan may differ as long as it is consistent with the core responsibilities, standards and qualifications for that job.
Kowa is committed to provide equal opportunity, employment, and advancement opportunities to all individuals. Kowa does not discriminate in employment opportunities or practices on the basis of race, color, religion, sex, national origin, age, sexual orientation, gender identity, genetic information, protected veteran, pregnancy, status as a qualified individual with a disability, or any other characteristic protected by Federal, State, or Local Laws. Employment decisions at Kowa will be based on merit, qualifications, and abilities.
Minimum Required Qualifications:
Bachelor’s degree from an accredited university/college required; preferably in life sciences
Regulatory Affairs Certificate (RAC) preferred
Minimum of 6 years of relevant prior experience in pharmaceutical regulatory document creation, management, and submission
Experience in submitting eCTD files
Able to travel to visit partners and attend relevant conferences or meeting outside of the United States.
Internal Number: 1853
About Kowa Pharmaceuticals of America, Inc.
A legacy of trust. A future of care. Established in 2008, Kowa Pharmaceuticals, Inc., is committed to developing and delivering safe, effective solutions in the field of cardiometabolic therapeutics. We do this by maintaining high ethical and professional standards—and it all starts with people. By empowering our employees to live this mission, we can create a healthier vision for the future.
Our Mission Is To:
Develop and commercialize safe, effective and high-quality pharmaceutical products at a reasonable cost
Be customer focused and provide the highest level of customer support and service
Conduct all business with honesty, professionalism and integrity
Maximize human capital by hiring, training and retaining the very best employees
Aggressively seek new marketing opportunities and maximize the potential of current products