Your role at BaxterAs a Global Regulatory Publishing Specialist, you will play a critical role in bringing life-saving products to patients by ensuring regulatory submissions are prepared, published, and delivered accurately and on time across global markets. In this role, you'll collaborate with cross-functional teams to support product registrations and lifecycle management activities while maintaining compliance with evolving health authority requirements and electronic submission standards.
What you'll be doing- Manages the preparation of regulatory submissions for major markets such as US, EU, Canada, Australia and other global regions.
- Perform technical validation and resolve publishing errors before dispatch.
- Support initial applications and lifecycle submissions.
- Drives integration and transition of products into regulatory operation processes.
- Compile technically compliant submission components and manage document formatting.
- May represent Global Publishing on project teams driving timelines for submission document deliverables.
- Partner closely with functional peer groups inside and outside the department.
- Provides system and process support, development, and training when necessary.
What you'll bring:- Bachelor's degree or equivalent combination of education and relevant professional experience.
- 1-3+ years of regulatory publishing or regulatory operations experience in the pharmaceutical or medical device industry would be an advantage.
- Hands on experience with pharmaceutical submissions and eCTD (INDs, BLAs. NDAs, ANDAs) and device submissions (eCopy and eStar)
- Experience in electronic publishing/document/data management systems (e.g. Veeva/RIM, ISI Toolbox, 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 and written communication and presentation skills
- Demonstrated interpersonal skills including strong negotiation skills
- Ability to independently identify compliance risks and escalate when necessary
We understand compensation is an important factor as you consider the next step in your career. At Baxter, we are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. The estimated base salary for this position is $72,000 - $99,000 annually. The estimated range is meant to reflect an anticipated salary range for the position. We may pay more or less than of the anticipated range based upon market data and other factors, all of which are subject to change. Individual pay is based on upon location, skills and expertise, experience, and other relevant factors. For questions about this, our pay philosophy, and available benefits, please speak to the recruiter if you decide to apply and are selected for an interview.
Baxter is committed to supporting the needs for flexibility in the workplace. We do so through our flexible workplace policy which includes a required minimum number of days a week onsite. This policy provides the benefits of connecting and collaborating in-person in support of our Mission. The flexible workplace policy is subject to local laws and legal requirements. At its discretion, Baxter may decide to adjust, suspend, or discontinue as business needs change.
Applicants must be authorized to work for any employer in the U.S. We are unable to sponsor or take over sponsorship of an employment visa at this time.
US Benefits at Baxter (except for Puerto Rico)This is where your well-being matters. Baxter offers comprehensive compensation and benefits packages for eligible roles. Our health and well-being benefits include medical and dental coverage that start on day one, as well as insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance. Financial and retirement benefits include the Employee Stock Purchase Plan (ESPP), with the ability to purchase company stock at a discount, and the 401(k) Retirement Savings Plan (RSP), with options for employee contributions and company matching. We also offer Flexible Spending Accounts, educational assistance programs, and time-off benefits such as paid holidays, paid time off ranging from 20 to 35 days based on length of service, family and medical leaves of absence, and paid parental leave. Additional benefits include commuting benefits, the Employee Discount Program, the Employee Assistance Program (EAP), and childcare benefits. Join us and enjoy the competitive compensation and benefits we offer to our employees. For additional information regarding Baxter US Benefits, please speak with your recruiter or visit our Benefits site: Benefits | Baxter
