Manager, Global Regulatory Affairs - Advertising & Promotion

Baxter Healthcare Corporation; Town of Texas, Round Lake (WI, IL); On-site; USD 112,000 - 154,000; Full time

Job summary

Join a leading healthcare company as the Manager of Regulatory Affairs. You will oversee the review of advertising materials and ensure compliance with regulations, impacting patient outcomes globally. This role requires strong leadership and regulatory knowledge, with a focus on collaboration and communication. Enjoy a competitive salary and comprehensive benefits.

Benefits

Medical and dental coverage

401(k) Retirement Savings Plan

Employee Stock Purchase Plan

Paid time off ranging from 20 to 35 days

Flexible Spending Accounts

Qualifications

• Minimum of 6 years of experience in Regulatory Affairs or Advertising & Promotion.
• Significant Regulatory knowledge in the Ad Prom space.

Responsibilities

• Review and approve advertising and promotional materials.
• Monitor and assure compliance with regulatory requirements.
• Manage complex projects and prioritize workload.

Skills

Proofreading

Writing Skills

Communication

Collaboration

Education

Bachelors degree in related scientific discipline

Tools

Adobe Acrobat

Job description

This is where you save and sustain lives

At Baxter we are deeply connected by our mission. No matter your role at Baxter your work makes a positive impact on people around the world. Youll feel a sense of purpose throughout the organization as we know our work improves outcomes for millions of patients.

Baxters products and therapies are found in almost every hospital worldwide in clinics and in the home. For over 85 years we have pioneered significant medical innovations that transform healthcare.

Together we create a place where we are happy successful and inspire each other. This is where you can do your best work.

Join us at the intersection of saving and sustaining lives where your purpose accelerates our mission.

Your Role at Baxter

The Manager of Regulatory AffairsAdvertising / Promotion reports to the Sr Director Regulatory Affairs and is responsible for the review of Advertising and Promotional (Ad Prom) materials and accountable for all operational aspects of regulatory submissions providing planning and technical support for Baxters products for one or more business units / countries.

What Youll Be Doing

Review and approve advertising and promotional materials such as Medical Devices

Initiate manage and maintain operational activities in support of new and existing marketing authorizations

Plan and manage complex projects and prioritize workload

Monitor evaluate and interpret all applicable regulatory requirements assure compliance with Baxter and external standards

Maintain appropriate communication within the RA function BU marketing and other functions primarily at the project team level

Communicate proactively and report to regulatory authorities

Evaluate technical and scientific information identify deficiencies implement and execute strategies to remediate risks

Assess impact of new regulations and provide feedback.

Set team group or service objectives to assure they align with the Regulatory strategy

Provide technical and strategic input for regulatory decisions

Support Regulatory Affairs teams ownership of the global Ad Prom process and system

May provide direct supervision of individuals including mentoring performance management and staffing decisions.

What Youll Bring

Minimum of 6 years of experience in Regulatory Affairs or Advertising & Promotion preferably managing people or projects.

Significant Regulatory knowledge in the Ad Prom (MLR) space and / or other Regulatory functions

Scientific knowledge

S trong ability to work with crossfunctional teams

Strong ability to oversee multiple projects in a matrix team environment.

Demonstrated excellent interpersonal and collaboration skills including diplomacy to negotiate conflicting priorities.

Excellent oral and written communication and presentation skills.

Ability to accomplish results through others

Ability to lead coach and motivate others

Bachelors degree or country equivalent in related scientific discipline

Experience with Veeva Promomats is a plus.

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 inperson in support of our Mission. The flexible workplace policy is subject to local laws and legal its discretion Baxter may decide to adjust suspend or discontinue as business needs change.

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 $112000 $154000 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. #LIASR2

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 wellbeing matters. Baxter offers comprehensive compensation and benefits packages for eligible roles. Our health and wellbeing benefits include medical and dental coverage that start on day one as well as insurance coverage for basic life accident shortterm and longterm 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 timeoff 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 additional information regarding Baxter US Benefits please speak with your recruiter or visit our Benefits site : Benefits Baxter

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.

Know Your Rights : Workplace Discrimination is Illegal

Reasonable Accommodations

Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If because of a medical condition or disability you need a reasonable accommodation for any part of the application or interview process please click on the link here and let us know the nature of your request along with your contact information.

Recruitment Fraud Notice

Baxter has discovered incidents of employment scams where fraudulent parties pose as Baxter employees recruiters or other agents and engage with online job seekers in an attempt to steal personal and / or financial information. To learn how you can protect yourself review our Recruitment Fraud Notice.

Required Experience :

Exec

Key Skills

Proofreading,Adobe Acrobat,FDA Regulations,Manufacturing & Controls,Biotechnology,Clinical Trials,Research & Development,GLP,cGMP,Product Development,Chemistry,Writing Skills

Employment Type : Full-Time

Experience : years

Vacancy : 1

Yearly Salary Salary : 112000 - 154000

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Regulatory Promotion • Round Lake, Texas, USA