Regulatory Affairs Specialist - Pharmaceutical (Remote)
- Compile and submit, in a timely manner, regulatory documents according to regulatory requirements
- Prepare, review, and validation packages and SOPs. Assist lower level team members on complex issues.
- Provide regulatory advice to project teams.
- Provide guidance and coaching for areas of responsibility to lower level team members.
- Respond to regulatory authorities questions with strict deadlines
- Maintain regulatory files in a format consistent with requirements
- Develop and initiate complex regulatory project plans
- Manage regulatory activities relating to specific portfolio of products/projects (product owner)
- Maintain and update existing regulatory authorizations
- Lead or represent Regulatory Affairs in project teams
- To perform this job successfully, an individual must possess the following:
- Exercise independent judgment
- Scientific knowledge
- Written and Verbal communication skills
- Knowledge of regulations
- Strong Negotiation skills
- Technical system skills (e.g. word processing, spreadsheets, databases, online research)
- Manage multiple projects and deadlines
- Ability to identify compliance risks and escalate when necessary
Equal Employment Opportunity
Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.
Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please send an e-mail to Americas_TTA@baxter.com and let us know the nature of your request along with your contact information.