Regulatory Affairs Specialist Jobs

About The Position

Requirements

• Bachelor’s degree or an equivalent combination of education and relevant professional experience.
• Hands-on experience with pharmaceutical submissions and eCTD submissions, including INDs, BLAs, NDAs, and ANDAs, and device submissions, including eCopy and eStar.
• Experience with electronic publishing, document, or data management systems, such as Veeva/RIM, ISI Toolbox, or eCTD Xpress.
• Familiarity with electronic submission regulations and guidance, including 21 CFR Part 11.
• Sound basis of regulatory knowledge.
• Ability to manage complex projects and timelines in a matrix team environment.
• Strong oral, written, and presentation skills.
• Demonstrated interpersonal skills, including strong negotiation skills.
• Ability to independently identify compliance risks and escalate them when necessary.
• Applicants must be authorized to work for any employer in the U.S.; Baxter is unable to sponsor or take over sponsorship of an employment visa.

Nice To Haves

• 1–3+ years of regulatory publishing or regulatory operations experience in the pharmaceutical or medical device industry is an advantage.

Responsibilities

• Manage preparation of regulatory submissions for major markets, including the US, EU, Canada, Australia, and other global regions.
• Perform technical validation and resolve publishing errors before dispatch.
• Support initial applications and lifecycle submissions.
• Drive integration and transition of products into regulatory operations processes.
• Compile technically compliant submission components and manage document formatting.
• Represent Global Publishing on project teams driving timelines for submission document deliverables, as needed.
• Partner with functional peer groups inside and outside the department.
• Provide system and process support, development, and training when necessary.

Benefits

• Medical and dental coverage starting on day one for eligible roles.
• Basic life, accident, short-term disability, long-term disability, and business travel accident insurance.
• Employee Stock Purchase Plan with the ability to purchase company stock at a discount.
• 401(k) Retirement Savings Plan with employee contribution options and company matching.
• Flexible Spending Accounts.
• Educational assistance programs.
• Paid holidays and paid time off ranging from 20 to 35 days based on length of service.
• Family and medical leaves of absence.
• Paid parental leave.
• Commuting benefits.
• Employee Discount Program.
• Employee Assistance Program.
• Childcare benefits.