Director, Regulatory Affairs

BeiGene, Ltd.; Cambridge; On-site; USD 171,000 - 232,000; Full time

Job summary

A leading oncology company is seeking a Director of Regulatory Affairs in Cambridge to provide strategic and operational regulatory direction. Responsibilities include overseeing submission documentation, liaising with the FDA, and managing a regulatory team. The role requires extensive experience in regulatory affairs and a strong educational background in relevant scientific disciplines.

Benefits

Medical benefits

Dental benefits

Vision benefits

401(k)

Paid Time Off

Wellness programs

Qualifications

• 8+ years with Master’s degree or 10+ years with Bachelor’s degree in related field.
• Experience with IND and NDA applications.
• Leadership in cross-functional product development teams.

Responsibilities

• Provides regulatory strategic direction and mentorship.
• Oversees submission of documentation for investigational and marketing registration.
• Liaises with FDA for drug development and regulatory issues.

Skills

FDA regulations

Drug development process

ICH guidelines

Clinical protocol/safety amendments

Education

Master’s degree in Biotechnology, Pharmacology, Toxicology

Bachelor’s degree in Biotechnology, Pharmacology, Toxicology

Job description

Director, Regulatory Affairs page is loaded

Director, Regulatory Affairs

Apply locations Cambridge time type Full time posted on Posted 2 Days Ago job requisition id R30233

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.

BeOne Medicines USA, Inc. (f/ka BeiGene) seeks Director, Regulatory Affairs in Cambridge, MA, USA:

Job Duties:

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

• Uses extensive knowledge of US, and ICH 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 ensuring timelines are met.

• Reviews sections of IND, NDA, and other submission documents in support of clinical trials and marketing applications, and their amendments in conformance with local regulatory requirements.

• Liaises and negotiates with FDA 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.

• Trains, develops, and manages an effective 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.

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

Domestic travel to client sites at unanticipated locations across the U.S. may be required 10-20% of the time.

Telecommuting is an option.

Minimum Requirements:

• Master’s degree (or its foreign degree equivalent) in Biotechnology, Pharmacology, Toxicology or a related scientific discipline, and eight (8) years of experience in the job offered or in any occupation in related field, OR

• Bachelor’s degree (or its foreign degree equivalent) in Biotechnology, Pharmacology, Toxicology or a related scientific discipline, and ten (10) years of progressively responsible experience in the job offered or in any occupation in related field.

Special Skill Requirements:

• Supporting and preparing IND and NDA applications including responsibility clinical protocol/safety amendments, supplements, and annual reports;
• Drug development process;
• FDA regulations;
• ICH guidelines;
• Leading cross-functional product development teams. Any suitable combination of education, training and/or experience is acceptable.

Domestic travel to client sites at unanticipated locations across the U.S. is required 10-20% of the time. Telecommuting is an option.

Disregard the below range, the selected candidate will earn a wage of $222,000.00 - $270,000.00 per annum.

Submit resume with references to: Req.#: 24-150829 at: ATTN: Amy Nobriga, [e-mail] .

#LI-DNI

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

Salary Range: $171,300.00 - $231,300.00 annually

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 [e-mail] .

About Us

BeOne is a global oncology company that is discovering and developing innovative treatments that are more affordable and accessible to cancer patients worldwide. With a broad portfolio, we are expediting development of our diverse pipeline of novel therapeutics through our internal capabilities and collaborations. We are committed to radically improving access to medicines for far more patients who need them. Our growing global team of more than 11,000 colleagues spans six continents. To learn more aboutBeOne, please visitwww.beigene.com and follow us onLinkedIn ,X (formerly known as Twitter),Facebook andInstagram .

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At BeOne, how we work is just as important as the work we do. Below are our Values that determine the decisions we make and how we do things.