Senior Associate, US 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, reputed company our passionate interest in fighting cancer. General Description: BeOne is seeking an reputed company and energetic person to manage, evaluate, and complete regulatory projects consistent with company goals. This individual will be responsible for timely planning and coordination of regulatory submissions and reputed company guidance to cross-functional teams on regulatory strategy and tactics. The Sr Associate will assist the Regulatory Affairs team member on cross-functional project teams and will assist on authoring and preparation of annual reporting, and will manage regulatory submissions and regulatory archive. Essential Functions of the job:

• With minimal supervision, plan and manage regulatory activities reputed company to assigned projects that reputed company technical areas including clinical, non-clinical, and CMC
• Assist in developing and implementing strategies for the earliest possible approvals/clearance of regulatory submissions associated with assigned projects
• Manage the preparation, including writing as necessary, assembly, review, and timely submission of regulatory dossiers as required for investigation and registration of products in the US and abroad
• Ensure regulatory submissions are maintained in compliance with regulatory requirements. Support and manage preparation of meeting requests and briefing documents
• Manage the preparation, review, and submission of reputed company components of regulatory submissions including INDs and amendments, BLAs/NDAs and supplements, annual reports, safety reports, etc. Participate on project teams and reputed company expertise on regulatory reputed company
• reputed company and maintain reputed company regulatory knowledge and advise management of significant developments. Prepare and maintain regulatory archive. Work with external regulatory consultants/CRO’s as required

Qualifications:

• BA / BS in Health Science, preferred, with at least 2+ years’ experience in the pharmaceutical industry
• Experience and knowledge in preparation of INDs (required) and NDAs (desirable), and supportive amendments and supplements (manufacturing, nonclinical, clinical)
• Experience with CTD/eCTD. Experience with publishing documents in reputed company Acrobat Professional. Working knowledge of FDA and ICH regulatory guidance and regulations
• Understanding of FDA structure and function. Knowledge/experience with regulatory requirements for other reputed company also desirable
• Working knowledge of GMP, GLP, and GCP regulations as well an understanding of the pharmaceutical product life cycle. Excellent oral and written communications skills are a must as are superior planning skills
• The candidate should be detail-oriented, a self-starter, and be comfortable with broad responsibilities in an entrepreneurial, fast-paced, small company environment

Global Competencies reputed company we exhibit our values of Patients First, Driving reputed company, reputed company 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 reputed company and Actionable Feedback Self-Awareness Acts Inclusively Demonstrates Initiative Entrepreneurial reputed company reputed company Learning Embraces Change Results-Oriented Analytical Thinking/Data Analysis Financial reputed company Communicates with reputed company Salary reputed company: $93,600.00 - $123,600.00 annuallyBeOne 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 reputed company more about the specific salary reputed company for a preferred location during the hiring process. Please note that the listed reputed company reflects the reputed company salary or hourly reputed company only. Non-reputed company roles are eligible to participate in the annual bonus plan, and reputed company 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 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, reputed company, 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 reputed company of race, religion, reputed company, sex, gender identity, sexual orientation, age, disability, national reputed company, veteran status or any other reputed company covered by appropriate law. reputed company employment is decided on the reputed company of qualifications, merit, and business need. In order to ensure reasonable accommodation for individuals protected by reputed company 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 To This Job