Snr Associate

General Description:_

Reports To: Director, Regulatory Affairs

Essential Functions of the job:

- Manage the preparation, assembly, review, and timely submission of Clinical Trial Application (CTA) and amendments through CTIS; Coordinate the internal response to questions from Health Authorities across Europe and provide guidance as needed.
- Work cross functionally with the project team and assist in the preparation, and review of regulatory documents, such as, IB and protocol
- Ensure regulatory submissions are maintained in compliance with regulatory requirements. Support the preparation of meeting requests and briefing documents for health authority meetings.
- Develop and maintain current regulatory knowledge and advise management of significant developments.
- Support developing and implementing regulatory strategies for the earliest possible approvals/clearance of regulatory submissions associated with assigned projects.
- Support and manage the preparation of meeting requests and briefing documents for interactions with EU Health Authorities.
- Coordinate the preparation, review, and submission of all components of regulatory submissions including ODD, CTAs, and MAAs, annual reports, safety reports, etc.

Skills and Experience:

- Excellent oral and written communications skills are a must as are superior planning, project management and interpersonal skills.
- Working knowledge/experience in preparation of CTA and supportive amendments and supplements (manufacturing, nonclinical, clinical).
- Working knowledge of EMA, European regulatory agencies and ICH regulatory guidance and regulations.
- 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.
- Language: Fluent English required (oral and written).
- Computer skills: proficiency with Microsoft Office (Word, Excel, Power point, OneNote etc.) and with Adobe Acrobat software for publishing.
- Education Required:

- Degree in Science (e.g. Chemistry, Pharmacy, Biochemistry, Biotechnology, Biology) or equivalent

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, 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.