Regulatory Affairs Specialist-Principal

Aquí es donde salvas y sostienes vidas

En Baxter, estamos profundamente conectados por nuestra misión. No importa tu rol en Baxter, tu trabajo tiene un impacto positivo en la gente alrededor del mundo. Sentirá un propósito en toda la organización, ya que sabemos que nuestro trabajo mejora los resultados para millones de pacientes.

Los productos y terapias de Baxter se encuentran en casi cada hospital del mundo, el clínicas y en los hogares. Por más de 85 años hemos sido pioneros en innovaciones médicas significativas que transforman el cuidado en salud.

Juntos creamos un lugar donde somos felices, exitosos y nos inspiramos mutuamente. Aquí es donde puedes hacer tu mejor trabajo.

Únete a nosotros en la intersección de salvar y sostener vidas-donde tu propósito acelera nuestra misión.

Your role at Baxter

Responsible for the implementation of complex regulatory strategies, obtain and maintain marketing authorizations for product(s) and communication of general regulatory requirements in support of licensing of Baxter’s products. Serves as a consultant to managers.

What you'll be doing

• Compile and submit, in a timely manner, regulatory documents according to regulatory requirements.

• Prepare, review, and approve labeling and SOP’s. 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.

• May review promotional material for compliance with local regulations.

What you'll bring

• Bachelor’s degree or country equivalent in pharmacy or related scientific discipline.

• Masters and/or PhD will be an advantage.

• 5+ years or more of experience in RA or related field (preferably medical device, pharmaceutical, CRO, or similar), including people management or projects.

• Ability to oversee multiple projects in a matrix team environment.

• Excellent oral and written communication and presentation skills.

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 $96,000 to $132,000 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. This position may also be eligible for discretionary bonuses. 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.

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.

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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 compen