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General Description:

The Director, Regulatory Affairs will be responsible for developing, implementing, and advising on North America (NA) regulatory strategies for development programs to secure and maintain market access in NA for product(s) in line with business objectives, and in coordination with the global regulatory leader and key internal stakeholders. This individual will manage NA regulatory aspects of compounds through all phases of development, post-approval, and life cycle of the product. The incumbent will provide leadership and strategic regulatory oversight from a NA perspective for designated projects ensuring that the latest requirements and standards are met. Externally, the individual will interface with outside regulatory agencies and more specifically, the FDA, and business partners regarding development, regulatory, and registration strategies within the US and Canada. The Director will also provide line management, people development, and performance management as well as support/lead development and implementation of department policies.

Essential Functions of the job:

+ Provides high level regulatory strategic and operational direction for NA and mentorship on projects including, but not limited to general regulatory strategies, regulatory requirements for clinical studies and marketing approval, regulatory strategic development plans and risk assessments, critical issue management and advice for the FDA and Health Canada interactions.

+ Uses extensive knowledge of US, regulatory requirements and applies this knowledge both strategically and operationally to development projects and marketed product regulatory issues to support corporate goals.

+ Oversees the preparation and submission of documentation to support investigational and marketing registration packages within the US and Canada ensuring timelines are met in alignment with the global strategy as determined by the global regulatory leader.

+ Reviews sections of the documents that will be utilized in the US and Canada in support of clinical trials and marketing applications, and their amendments in conformance with local regulatory requirements

+ Liaises and negotiates with the FDA and Health Canada as needed for all aspects pertaining to drug development including resolution of key regulatory issues and to expedite approvals of product and labeling changes

+ Maintains awareness of global regulatory environment and assess impact of changes on business and product development programs. Facilitate policy and development of standard interpretation of global regulation

+ Integrates functional expertise with business knowledge to solve problems and make good decisions for the overall business

+ Trains, develops, and manages an effective regional regulatory team both via direct and indirect reporting structure

+ Builds partnerships with senior key stakeholders from other functions to ensure that strategic business goals are met through the sharing of knowledge and expertise

+ Manages critical issues, taking leadership for the regulatory contribution.

+ Responsible for assisting with the development and implementation of regulatory processes

+ Recruits, develops, manages, and mentors regulatory professionals and helps create a goal-oriented culture

Supervisory Responsibilities:

+ Some supervisory responsibilities for multi-level regulatory team(s)

Computer Skills:

+ Experience with Microsoft Office suite

+ Veeva regulatory publishing

+ PowerPoint presentation authoring and presentation

Other Qualifications:

+ 10+ years of experience in the biotechnical or pharmaceutical industry, and a minimum of 5 years’ experience in a Regulatory capacity with a broad background

+ Bachelor’s degree required; advanced degree preferred

+ Preferred candidates will have experience working as a lead in Regulatory Affairs with the FDA and prior experience with both small molecules and biologics

+ Thorough understanding of drug development process and the pharmaceutical industry and healthcare environment including regulatory requirements and policy trends

+ Extensive regulatory experience with INDs/CTAs, NDAs/BLAs, lifecycle management, interactions with Health Authorities, leading and managing regulatory teams, developing and implementing regulatory strategies with a proven track record of significant regulatory accomplishments

+ Strong business acumen and ability to make sound decisions that contribute positively to the business

+ Very strong strategic skills including creativity and effectiveness in identifying and addressing major strategic challenges (e.g., new competition, shifting market environment) and the ability to balance short-term needs with long-term vision

+ Proven ability to deliver on goals within a cross-functional team/partnership environment with a high level of professionalism

+ Excellent verbal and written skills; Able to analyze, define and effectively convey difficult and complex issues in a way that accurately and persuasively communicates the issues to be internal and external stakeholders

+ Skilled in conflict resolution/negotiation. Fosters open communication. Listens and facilitates discussion

+ Strong negotiating skills and ability to think creatively and develop creative solutions

+ Proven ability to build trust and respect within the organization

+ Ability to prioritize and handle multiple projects simultaneously

+ Interacts with external business partners and Regulatory Agencies

+ Proven ability to build trust and respect within the organization.

+ Ability to prioritize and handle multiple projects simultaneously

Travel:

Business travel to be 10-20% as required

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.