Job Description
General Description/Scope of Responsibilities (Internship):
The company is seeking a motivated and talented individual to join our Reg CMC small molecule team which offers meaningful project experiences that gives interns the opportunity to gain valuable Biotech experience as they complete their academic journey.
The Regulatory Affairs CMC Intern will support regulatory projects consistent with company goals by working closely with the hiring manager and cross-functional team members, including Quality Assurance, Supply Chain, CMC, and IT. 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 to process optimization in knowledge management. Specifically, the intern will:
- Be exposed to the broad scope of global Regulatory Affairs and specifically CMC Regulatory Affairs and the role’s contribution to drug development and patients’ access to medicines.
- Learn about the role of global Health Authorities in the drug development process.
- Gain hands-on experience in preparing regulatory documents for submission to global health authorities.
- Raise awareness of the differences in regulatory requirements across regions.
Experience CMC technical product development and manufacturing functions in relation to regulatory affairs.
Essential Functions of the Internship: - Responsible for maintaining accurate CMC information in the Regulatory Information Management system
- Data remediation
- Creation and maintenance of CMC Submission Content
- Uploading HA Correspondence/HA Questions/Commitments
- Maintain internal Regulatory CMC trackers
- Contribute to Reg CMC process improvements
- Support the drafting of CTD CMC sections to ensure on-time and high-quality global applications for direct submission to Health Authorities as needed.
- Provide support to Reg CMC team or hiring manager with Regulatory submissions and other tasks as needed
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
Other Qualifications: - Awareness of processes for working in a regulated field preferred
- Basic knowledge of healthcare industry and strong passion for biotech
- Legally authorized to work in the United States without needing sponsorship for employment now or in the future
- Ability to work independently on assignments with routine check-ins
- Strong written and oral communication skills
- Organized, responsible, resourceful, and detail-oriented
- Able to work in a cross-cultural team environment
- Able to work remotely using MS TEAMS and other collaboration tools
Job Tags
Remote job, Contract work,