BeiGene 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.Job Description**Position Summary:**BeiGene 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 small molecule market product CMC-related global post-approval regulatory submissions to meet the aggressive timelines.**Essential Functions of the Job:**+ 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 market product post-approval applications.+ Develop regulatory strategy and execute in the preparation of timely responses to small molecule CMC regulatory questions related to market product post-approval submissions as needed for the assigned project.+ Work collaboratively with cross-functional leads and communicates CMC regulatory strategies for the assigned projects. Provide appropriate regulatory impact assessment on post-approval CMC related change controls.+ Lead regulatory risk assessment, identify key CMC regulatory issues and mitigation activities needed for market product post-approval submissions. 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 comments on new global guidance through companys commenting process.**Qualifications:**+ 4 – 7+ years of related pharmaceutical or biopharmaceutical industry regulatory CMC experience with proven record of leading global submissions for market product post-approval applications and subsequent response to HA queries.+ In-depth knowledge of ICH requirements and US/EU regulatory post-approval requirements. Knowledge/experience with regulatory post-approval requirements for ROW regions and GMP regulation is a plus.+ Experience in authoring complex technical documents and regulatory CTD (M2/M3) sections.+ 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.**Education Required:** BA/BS Degree in sceintific disciplines, MS/PhD preferred. Educational background in scientific disciplines and expertise in at least one area in pharmaceutical development (chemical process, formulation, manufacturing, QC, QA, etc).**Computer Skills:** Microsoft 360**Travel for Work:** 0-5%**Competencies:****Ethics -** Treats people with respect; Inspires the trust of others; Works with integrity and ethically in accordance with BeiGenes Code of Business Conduct and Ethics, policies and procedures.**Planning/Organizing** **-** Prioritizes and plans work activities; Uses time efficiently; Completes administrative tasks correctly and on time; Follows instructions and responds to management direction.**Communication** **-** Listens and gets clarification; Responds well to questions; Speaks clearly and persuasively in positive or negative situations; Writes clearly and informatively; Able to read and interpret written information.**Teamwork -** Balances team and individual responsibilities; Gives and welcomes feedback; Contributes to building a positive team spirit; Puts success of team above own interests; Supports everyone’s efforts to succeed; Contributes to building a positive team spirit; Shares expertise with others.**Adaptability ** Able to adapt to changes in the work environment; Manages competing demands; Changes approach or method to best fit the situation; Able to deal with frequent change, delays, or unexpected events.**Technical Skills** **-** Assesses own strengths and development areas; Pursues training and opportunities for growth; Strives to continuously build knowledge and skills; Shares expertise with others.**Dependability** **-** Follows instructions and responds to management direction; Takes responsibility for own actions; Keeps commitments; Commits to long hours of work when necessary to reach goals; CompletesWe are proud to be an equal opportunity employer and we value diversity. BeiGene 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.
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