Regulatory Affairs, Europe

BeiGene is seeking a motivated and talented individual to join our 11-week internship program which offers meaningful project experiences that gives interns the opportunity to gain valuable Biotech experience as they complete their academic journey.

The Regulatory Affairs intern will support regulatory projects consistent with company goals by working closely with the hiring manager and cross-functional team members. The focus of the internship is for the intern to develop a deeper understanding of the drug development process and regulatory requirements in a professional work environment, while contributing management of regulatory documents.

Essential Functions of the Internship:

- Archiving documents from Health Authorities in the Veeva Vault system
- Support in preparing dossiers for submissions to Health Authorities
- Support in preparing regulatory documents for submission to health authorities
- Searching for guidelines and other documents in the health authority websites

Supervisory Responsibilities:

- No

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.

Computer Skills: Proficient in Microsoft Office, Internet and willingness to work in internal systems such as Veeva Vault after appropriate training.

Other Qualifications:

- Speaks and understands English language fluently
- Ability to work independently on routine assignments with daily check-ins
- Strong written and oral communication skills
- Organized, responsible, and detail-oriented
- Ability to work in a cross-cultural team environment

Travel: None

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.