Associate Director, Regulatory CMC (Small Molecule) job opportunity at BeOne Medicines.

Home Jobs In United States Of America Tag: Regulatory CMC (Small Molecule) Associate Director, Regulatory CMC (Small Molecule) position at BeOne Medicines


DatePosted 29 Days Ago bot
BeOne Medicines Associate Director, Regulatory CMC (Small Molecule)
Experience: 8-years
Pattern: Remote
Country:
apply Apply Now
Salary:
Status:

Regulatory CMC (Small Molecule)

Copy Link Report
degreePhD
loacation Remote (US), United States Of America
loacation Remote (US)....United States Of America

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: BeOne is seeking an experienced and energetic regulatory professional to manage, evaluate, and complete regulatory projects consistent with company goals. This individual will be responsible for development of strategies, planning, drafting, and managing CMC-related regulatory submissions and HA interactions to meet the aggressive timelines for the assigned projects. The individual will provide support to cross-functional teams on CMC regulatory strategies and process optimizations on relevant topics.   Essential Functions of the job: Lead, develop and implement small molecule CMC regulatory strategies as well as authoring CTD CMC sections for the assigned project to ensure on-time and high-quality global submissions for investigational, market, and post-approval applications. Develop regulatory strategy and execute in the preparation of timely responses to small molecule CMC regulatory questions, pre-meeting packages, and interactions with Heath Authorities as needed for the assigned project Work collaboratively with cross-functional leads and communicates CMC regulatory strategies for the assigned projects. Lead regulatory risk assessment, identify key CMC regulatory issues and mitigation activities needed throughout product life cycle. Escalate the critical issues to senior management timely. Lead or contribute to development of internal small molecule CMC regulatory guidance and working instructions. Ensures proper CMC regulatory assessments and actions are taken when recalls or product complaints arise during product lifecycle for the assigned project. Provide CMC regulatory review for clinical protocols and investigator brochures, etc. for the assigned project. Provide comments on new global guidance through company’s commenting process.   Supervisory Responsibilities: The position may or may not manage direct report(s). Computer Skills: Microsoft 360, Familiarity with Veeva is a plus.   Qualifications: 8+ years of related pharmaceutical or biopharmaceutical industry regulatory CMC experience. Education Required: BA/BS Degree in scientific disciplines, MS/PhD preferred. A proven record of leading Health Authority interactions, CTA, NDA/MAA, post-approval preparation, submission, and subsequent response to HA queries. In-depth knowledge of ICH requirements and US/EU regulatory requirements. Knowledge/experience with regulatory requirements for rest of world regions and GMP regulation is a plus. Demonstrated leadership as a people manager. Experience in authoring complex technical documents, CTD M2 and M3 sections, and life cycle management. Educational background in scientific disciplines and expertise in at least one area in pharmaceutical development (chemical process, formulation, manufacturing, QC, QA, etc.). Excellent oral and written communications skills are a must-have. The candidate should be detail-oriented, a self-motivated, and be comfortable with broad responsibilities in an entrepreneurial, fast-paced environment. Travel As needed. 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: $142,000.00 - $192,000.00 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 accommodationsus@beonemed.com .

Other Ai Matches

remote-jobserver Remote
Associate Director, Clinical Biomarker & Translational Medicine for Oncology (Solid Tumor Portfolio, GI franchise) Applicants are expected to have a solid experience in handling Clinical Biomarker & Translational Medicine for Oncology (Solid Tumor Portfolio, GI franchise) related tasks
remote-jobserver Remote
Executive Director, Global Clinical Pharmacology & Development Technology Solutions Applicants are expected to have a solid experience in handling Global Clinical Pharmacology & Development Technology Solutions related tasks
remote-jobserver Remote
Clinical Research Associate Applicants are expected to have a solid experience in handling Job related tasks
remote-jobserver Remote
Associate Director, Medical Writer - Publications Applicants are expected to have a solid experience in handling Medical Writer - Publications related tasks
remote-jobserver Remote
Senior Clinical Research Associate Applicants are expected to have a solid experience in handling Job related tasks
remote-jobserver Remote
Director, Digital Marketing, Market Access Strategic Marketing Applicants are expected to have a solid experience in handling Digital Marketing, Market Access Strategic Marketing related tasks
Senior Analyst, QC Chemistry, Capillary Electrophoresis (Hopewell, NJ) Applicants are expected to have a solid experience in handling QC Chemistry, Capillary Electrophoresis (Hopewell, NJ) related tasks
Data Reviewer, QC, US Site (Hopewell, NJ) Applicants are expected to have a solid experience in handling QC, US Site (Hopewell, NJ) related tasks
remote-jobserver Remote
Summer Internship: US Commercial Learning and Development Intern (Remote) Applicants are expected to have a solid experience in handling Job related tasks
remote-jobserver Remote
Regional Business Manager, Southeast Applicants are expected to have a solid experience in handling Southeast related tasks
remote-jobserver Remote
Study Start-up Specialist Applicants are expected to have a solid experience in handling Job related tasks
remote-jobserver Remote
Associate Director, Regulatory Affairs, CMC Applicants are expected to have a solid experience in handling Regulatory Affairs, CMC related tasks
remote-jobserver Remote
Summer Internship: Corporate Affairs Intern (Remote) Applicants are expected to have a solid experience in handling Job related tasks
remote-jobserver Remote
Vice President, AI & Innovation Applicants are expected to have a solid experience in handling AI & Innovation related tasks
remote-jobserver Remote
Summer Internship: US Field Medical Excellence Intern (Remote) Applicants are expected to have a solid experience in handling Job related tasks
remote-jobserver Remote
Senior Director, Innovation and Commercial AI Enablement Applicants are expected to have a solid experience in handling Innovation and Commercial AI Enablement related tasks
Summer Internship: Strategic Partnerships Intern Applicants are expected to have a solid experience in handling Job related tasks
remote-jobserver Remote
Summer Internship: R&D Quality Business Operations Intern (Remote) Applicants are expected to have a solid experience in handling Job related tasks
Study Start-Up Head, LATAM Applicants are expected to have a solid experience in handling LATAM related tasks
Associate Director/Senior Manager, Business & Strategic Planning & Operations (JAPAC) Applicants are expected to have a solid experience in handling Business & Strategic Planning & Operations (JAPAC) related tasks
Summer Internship: QA Validation Intern - Hopewell Applicants are expected to have a solid experience in handling Job related tasks
(Senior) Associate, Clinical Site Budget Planning Applicants are expected to have a solid experience in handling Clinical Site Budget Planning related tasks
remote-jobserver Remote
Senior Director, SAP Global Order to Cash Applicants are expected to have a solid experience in handling SAP Global Order to Cash related tasks