Regulatory Affairs Senior Associate

BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When 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 Senior Associate, Regulatory Promotional Operations, is responsible for assisting with driving standards, planning, coordination and processing of promotional materials. This person will also support the preparation of regulatory submissions for advertising and promotional materials. Strong communication (written and verbal), and organizational skills are required with a collaborative, hands-on, can-do attitude.

Essential Functions of the Job:

• Assists in acting as a centralized knowledge hub of Promotional Review Committee (PRC) and provides guidance to project owners/agencies/reviewers on the process to streamline material review.

• Collaborates with brand to set prioritization of review and manage review priorities against business needs.

• Assists in triage of materials for appropriate review and provides guidance on submission readiness.

• Reviews materials to ensure readiness according to established criteria and templates as applicable (e.g. proper referencing and annotations).

• Drives the process within the document management system (Veeva PromoMats) for review and management of promotional materials.

• Works in partnership with Global Regulatory Operations to prepare Subpart H and 2253 submissions in accordance with FDA requirements and timelines. 

• Contributes to the modification, development and implementation of company practices and policies for advertising and promotional activities.

• Establishes and maintains effective working relationships with cross-functional partners.

• Assists with periodic regulatory compliance audits to ensure effective proactive adherence to required government and corporate standards.

• Assists in training stakeholders on PRC process.

• Other tasks and responsibilities as assigned.
   

Supervisory Responsibilities:  

• N/A

Computer Skills:

• Experience using electronic content management systems.

• Direct experience with Veeva PromoMats and RIM is highly desirable.

• Proficiency in MS Office Suite applications. Adobe Acrobat.
   

Other Skills:

• BA/BS degree (BS/BSc or BA), (preferably in a scientific or health-related discipline) with a minimum of 2+ years of direct experience in a Regulatory function or equivalent.

• General knowledge of advertising/promotional regulations, guidelines and best practices

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

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

• Excellent oral and written communication skills are a must, as are superior planning skills.

• The candidate should be detailed-oriented, a self-starter, and be comfortable with broad responsibilities in an entrepreneurial, fast-paced environment.
   

Travel: N/A

Global Competencies

When 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 Mindset
• Continuous Learning
• Embraces Change
• Results-Oriented
• Analytical Thinking/Data Analysis
• Financial Excellence
• Communicates with Clarity

BeOne is committed to fair and equitable compensation practices. Actual compensation packages are determined by several factors that are unique to each candidate, including but not limited to job-related 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 base 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. All Company employees have the opportunity to own shares of BeOne Medicines Ltd. stock because all 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 origin, veteran status or any other basis covered by appropriate law. All 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 Disabilities Act 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].