Regulatory Affairs Associate

Beigene, Ltd. Apac Emeryville , CA 94608

Posted 2 months ago

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.

General Description:

BeiGene is seeking an experienced 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 provide guidance to cross-functional teams on regulatory strategy and tactics. The 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 related to assigned projects that span 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 all components of regulatory submissions including INDs and amendments, BLAs/NDAs and supplements, annual reports, safety reports, etc. Participate on project teams and provide expertise on regulatory matters.

  • Develop and maintain current regulatory knowledge and advise management of significant developments. Prepare and maintain regulatory archive. Work with external regulatory consultants/CRO's as required.

Qualifications:

  • 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 Adobe 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 regions 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.

Education Required:

BA / BS in Health Science, preferred, with at least one year experience in the pharmaceutical industry

Competencies:

Ethics

  • Treats people with respect; Inspires the trust of others; Works with integrity and ethically; Upholds organizational values.

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, responds to management direction; Takes responsibility for own actions; Keeps commitments; Commits to long hours of work when necessary to reach goals; Completes tasks on time or notifies appropriate person with an alternate plan.

Quality

  • Demonstrates accuracy and thoroughness; Looks for ways to improve and promote quality; Applies feedback to improve performance; Monitors own work to ensure quality.

Analytical

  • Synthesizes complex or diverse information; Collects and researches data; Uses intuition and experience to complement data.

Problem Solving

  • Identifies and resolves problems in a timely manner; Gathers and analyzes information skillfully.

Project Management

  • Communicates changes and progress; Completes projects on time and budget.

We 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, non-disqualifying physical or mental 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.


icon no score

See how you match
to the job

Find your dream job anywhere
with the LiveCareer app.
Mobile App Icon
Download the
LiveCareer app and find
your dream job anywhere
App Store Icon Google Play Icon
lc_ad

Boost your job search productivity with our
free Chrome Extension!

lc_apply_tool GET EXTENSION

Similar Jobs

Want to see jobs matched to your resume? Upload One Now! Remove
Senior Manager Regulatory Affairs

Dynavax

Posted 2 weeks ago

VIEW JOBS 3/14/2020 12:00:00 AM 2020-06-12T00:00 Overview This position will lead the regulatory advertising and promotion activities pertaining to the company's marketed product, HEPLISAV-B®, and will lead specific, and support all, regulatory activities across the company's overall regulatory strategy, clinical regulatory and regulatory-CMC, spanning preclinical and Phase 1 product development to marketed product activities. The duties of the position will include developing and implementing advertising and promotion regulatory strategies for the product. Provide guidance to the Dynavax Commercial and Medical teams and ensure timely preparation external materials. In the leadership and support roles for the company's overall regulatory strategy, clinical regulatory and regulatory-CMC, this position is responsible for generating organized and scientifically valid submissions to regulators, building relationships with regulator contacts and developing internal regulatory strategies based on regulations, guidance, precedents and regulatory landscape. Responsibilities * Partner with project leaders, department heads, and project teams to collaboratively develop and implement the company's advertising and promotion strategies while maintaining regulatory compliance. * Provide strategic input and function as the regulatory lead on project teams, and will provide guidance/advice to the project leader and team on regulatory matters. * Provide US, EU, and/or global operational input and coordination of regulatory strategies. * Manage the assembly, review, and approval of assigned regulatory dossiers and documents (content) of regulatory submissions. * Provide operational input to product lifecycle issues. * Serve as the primary point-of-contact with the regulators. * Lead and/or participate in meetings with regulatory authorities, as appropriate * Manage the regulatory work of CROs and consultants. * May provide regulatory due-diligence support for partnering and licensing activities. * Work closely with and coordinate project-related activities with Regulatory Operations to ensure appropriate regulatory support of projects. * Supports the organization in maintaining a work environment focused on quality and that fosters learning, open communication, collaboration, integration, and teamwork. Qualifications * A BA/BS with 5+ years' regulatory advertising and promotion experience or PharmD with 3+ years' regulatory advertising and promotion experience, and 2+ years of other regulatory strategy experience. * Broad to in-depth understanding of FDA drug regulations and guidelines. * Previous experience working with CDER and/or CBER experience. * Previous experience supporting Regulatory CMC is desired. * Experience and knowledge in the preparation and submission of major regulatory submissions, supportive amendments, and supplements. * Collaborative and team-oriented to foster effective and positive interactions across functions, project teams, regulatory agencies, and corporate partners. * Proven ability to manage and effectively negotiate with project team members. * Demonstrated effective written and verbal communication skills. * Excellent organizational skills, including the ability to prioritize and be flexible to changing priorities. Great attention to detail is a must. Dynavax is an Equal Opportunity Employer Dynavax Emeryville CA

Regulatory Affairs Associate

Beigene, Ltd. Apac