The Regulatory Affairs Manager plays a significant role in supporting US and Canada submission related activities. This position will serve as the regulatory consultant to project teams and governmental regulatory agencies, and interacts with internal and external personnel on matters often requiring coordination between organizations. The Regulatory Affairs Manager represents the organization as a key contact on contracts and/or projects.
• Responsible for drug establishment registration and drug product listing activities.
• Maintain FDA, EMA, ICH and related statutory guidelines.
• Interact with regulatory agencies on projects.
• Monitor and improve regulatory compliance/tracking systems.
• Leads regulatory strategy development and implementation planning, including recommending changes for labeling, manufacturing, marketing and clinical protocols.
• Provides guidance and recommendations on regulatory and quality issues as required.
• Reviews all product labeling and marketing materials for assigned products to ensure compliance with regulatory requirements. Or coordinates with colleagues handling marketing materials reviews for assigned products.
• Reviews all document control change requests for regulatory consequences.
• Provides advice to clinical teams on appropriate regulations and interpretations.
• Coordinates reviews and provides input to reports for submission. Review labeling, training, promotional and advertising material.
• Develop and maintain regulatory affairs department procedures.
• Comply with applicable FDA and international regulatory laws/standards and the Santen Business Code of Conduct.
• BS in life science or related pharmaceutical field required; advanced degree preferred.
• Five to eight (5-8) years of pharmaceutical/biotech industry experience.
• Regulatory Affairs Certification preferred.
• Working knowledge of US & Canadians regulations and guidelines.
• Excellent verbal and written communications skills required.
• Experience compiling NDAs and document packages for health authorities.
• Proficiency in MS Office.
• Ability to communicate effectively across all organizational levels, including with Santen Inc. management.
• Previous work experience working cross-culturally, especially with Japanese companies, a plus.
• Ability to work independently as well as collaboratively across functions.
• Highly developed understanding of drug development.
• Must be able to work effectively in a fast-paced work environment, managing multiple priorities and tasks along with being adept in project management.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed are representative of the knowledge, skill, and/or ability required.
• Must be able to spend considerable time at a computer.
• Must be able to stand, kneel, and stoop for filing.
• Must be able to use the telephone and communicate clearly with individuals who are both internal and external.
• Must be able to travel nationally and internationally, when required, up to 10%.