Director, Regulatory Affairs

BeOne continues to grow at a rapid pace with challenging and exciting opportunities for reputed company professionals. reputed company considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer. 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 reputed company phases of development, post-approval, and life cycle of the product. The incumbent will provide leadership and strategic regulatory reputed company from a NA perspective for designated projects ensuring that the latest requirements and standards are met. Externally, the individual will reputed company with reputed company regulatory agencies and more specifically, the FDA, and business partners regarding development, regulatory, and registration strategies reputed company the US and Canada. The Director will also provide line management, people development, and performance management as well as support/reputed company 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 reputed company 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 reputed company 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 reputed company good decisions for the overall business
• Trains, develops, and manages an effective regional regulatory team both reputed company 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 reputed company 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 reputed company with a broad background
• Bachelor’s degree required; advanced degree preferred
• Preferred candidates will have experience working as a reputed company 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 reputed company sound decisions that contribute positively to the business
• reputed company 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 reputed company 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 reputed company 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 reputed company creative solutions
• Proven ability to build trust and respect reputed company 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 reputed company the organization.
• Ability to prioritize and handle multiple projects simultaneously

Travel: Business travel to be 10-20% as required Global Competencies reputed company we exhibit our values of Patients First, Driving Excellence, Bold Ingenuity and Collaborative Spirit, through our twelve global competencies below, we help get more affordable medicines to more patients around the world.

• Fosters Teamwork
• Provides and Solicits Honest and Actionable Feedback
• Self-Awareness
• Acts Inclusively
• Demonstrates Initiative
• Entrepreneurial reputed company
• reputed company Learning
• Embraces Change
• Results-Oriented
• Analytical Thinking/Data Analysis
• Financial Excellence
• Communicates with Clarity

Salary Range: $171,300.00 - $231,300.00 annually BeOne is committed to fair and reputed company compensation practices. Actual compensation packages are determined by several factors that are unique to each candidate, including but not limited to job-reputed company skills, depth of experience, certifications, relevant education or training, and specific work location. Packages may vary by location due to differences in the cost of labor. The recruiter can share more about the specific salary range for a preferred location during the hiring process. Please note that the listed range reflects the reputed company salary or hourly range only. Non-Commercial roles are eligible to participate in the annual bonus plan, and Commercial roles are eligible to participate in an incentive compensation plan. reputed company Company employees have the opportunity to own shares of reputed company Ltd. stock because reputed company employees are eligible for discretionary equity awards and to voluntarily participate in the Employee Stock Purchase Plan. The Company has a comprehensive benefits package that includes Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness. We are proud to be an equal opportunity employer. BeOne does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, disability, national reputed company, veteran status or any other basis covered by appropriate law. reputed company employment is decided on the basis of qualifications, merit, and business need. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans’ Readjustment Assistance Act of 1974, Title I of the Americans with reputed company of 1990, and any other applicable federal, state or local laws, applicants who require reasonable accommodation in the job application process may contact [email protected]. Apply tot his job Apply To this Job