Regulatory Affairs Specialist
GE HealthcareSalary not specified
Full Time
Junior (1 to 2 years)
Not SpecifiedCompensation
Entry Level & New GradExperience Level
Full TimeJob Type
UnknownVisa
PharmaceuticalsIndustries
Requirements
- 0-2 years pharmaceutical experience
- Foundational knowledge of global regulatory practices, submission guidelines and requirements
- BA/BS degree, science/technology field preferred
- Proficient in the English language both written and oral, and able to communicate effectively in written form with non-English speakers
- Demonstrates basic presentation skills needed to deliver content to a variety of audiences
- Demonstrates the ability to execute a non-complex project, including the ability to prioritize tasks with strong attention to detail
- Communicates project status and updates, as appropriate, to relevant stakeholders
- Applies critical thinking skills to daily workload decisions, in alignment with group/company objectives
- Seeks to understand stakeholder needs, priorities, working processes, and activities
- Good understanding of desktop application software suites
- Practical knowledge of computer systems in an R&D environment
- Understands the importance of resolving issues in a timely manner
- Escalates questions and issues as they arise
- Engages relevant stakeholders to help address the problem, as appropriate
Responsibilities
- Tracks, collects, and reviews all components for routine submissions to Health Authorities
- Interacts with responsible parties for quality submission documents for routine submissions
- Troubleshoots issues found in components received and interacts with responsible parties for clarification or revision
- Prepare Cover Letter, FDA Forms and submission content plan for routine submissions
- Perform submission verification on published submissions to confirm eCTD compliant
- Update RIM system with US planned submissions and update entries with submitted submissions
- Participates in submission team meeting as applicable
- Coordinate non-eCTD submissions with International Regulatory Team lead
- Other miscellaneous regulatory operational activities as needed
Skills
Key technologies and capabilities for this role
Questions & Answers
Common questions about this position
What experience level is required for the Submission Specialist role?
The position requires 0-2 years of pharmaceutical experience.
What education is needed for this position?
A BA/BS degree in a science or technology field is preferred.
What key skills are necessary for this job?
Candidates need foundational knowledge of global regulatory practices and submission guidelines, strong communication skills including proficiency in English, and the ability to prioritize tasks with attention to detail and critical thinking.
What is the company culture like at Bristol Myers Squibb?
The culture is described as challenging, meaningful, and life-changing, with opportunities to grow alongside high-achieving teams on work that transforms patients' lives, emphasizing balance and flexibility.
Are there any application tips for this role?
Bristol Myers Squibb encourages candidates to apply even if their resume doesn't perfectly match the role.
Bristol-Myers Squibb
Develops and delivers biopharmaceutical medicines
About Bristol-Myers Squibb
Bristol Myers Squibb (BMS) develops and delivers medicines aimed at treating serious diseases, focusing on areas like cancer, autoimmune diseases, and heart conditions. The company conducts extensive research and development to create new drugs, which are sold after receiving regulatory approval. BMS also produces generic drugs, offering affordable alternatives that meet the same quality standards as their branded counterparts. What sets BMS apart from competitors is its dual focus on both innovative and generic medicines, enhancing access to healthcare. The company's goal is to improve patient outcomes while maintaining a commitment to sustainability and corporate responsibility.
New York City, New YorkHeadquarters
1887Year Founded
$33,706.1MTotal Funding
IPOCompany Stage
Biotechnology, HealthcareIndustries
10,001+Employees