Senior Director Global Regulatory Affairs, Advanced Surgery, medical devices and biologics (REMOTE)

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.

You’ll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.

Baxter’s 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 :

Baxter’s Advanced Surgery, a $1B business and part of our Medical Products and Therapies Global Business Unit (GBU), offers a product portfolio of hemostats, sealants and adhesion prevention products to enable surgeons to act with speed and precision.

As the Senior Director Regulatory Affairs, Advanced Surgery you will be responsible for global strategic direction and performance (strategy and execution) of the Regulatory Affairs (RA) function within the division including development, implementation and management of global regulatory strategies and proactively influencing and shaping the regulatory environment in support of business goals and strategies.

You will interface with a variety of management levels on significant matters, often requiring the coordination of activity across multiple functions, and at times, across different divisions and segments.

You will manage all regulatory activities associated with Advanced Surgery. You will also participate in the Advanced Surgery Leadership Team as a key business partner to provide regulatory strategy and guidance for new product development (NPD) and business growth and expansion strategies, as well as to ensure the alignment of regulatory priorities with the business objectives.

What You’ll Be Doing :

• Proactively develop new innovative approaches for new products and expanded indications
• Accountable for alignment of regulatory strategy to business strategy
• Anticipate regulatory obstacles and emerging issues throughout the product lifecycle and develop solutions with members of Regulatory and other cross-functional teams
• Accountable for regulatory strategy and vision within the business unit
• Identify risk areas within the global business unit and develop alternative courses of action including anticipation of regulators responses through scenario planning and development of contingency plans working with cross-functional partners
• Effectively communicates through presentations and written communications regulatory strategies and project developments to project teams, colleagues, line management, and key stakeholders for alignment and to ensure awareness of issues that may impact regulatory success.
• Negotiate and interact with the regulatory authorities including the oversight, planning and leadership of meetings
• Maintains awareness of the global regulatory environment and assess the impact of changes on business and product development programs.

Facilitates policy and development of the standard interpretation of global regulation.

• Oversee development and negotiation of overall plans regarding safety, efficacy, and quality to assure viability for global registrations
• Accountable for ensuring that regulatory submissions meet appropriate standards and content requirements
• Identify potential strategic / tactical decisions that will affect the company's success for long term range planning (LRP)
• Develop and manage budget for the business unit RA group
• Recruit, develop and lead a team of regulatory professionals in development of strategic plans and regulatory submissions
• Oversee team management and development
• Engaged in policy development within organization and with external groups
• Guide proactive relationships with regulatory authorities to facilitate interactions for critical issues
• Influence the direction of the regulatory function; ensure development of competencies and capabilities for current and future goals
• 25% travel

Your Team :

The Senior Director Regulatory Affairs, Advanced Surgery reports to the Vice President, Global Regulatory Affairs. As the Senior Director you will have a geographically dispersed team of approximately 25.

You will collaborate and interface with other GBU and regional RA, marketing, NPD R&D, sustaining engineering, business operations, service, sales, corporate engineering, Advanced Surgery cross-functional Leadership Team, etc.

Finally you will be a member of Regulatory Affairs Leadership Team (RALT).

Your Location :

The role is located at our global corporate headquarters in the greater Chicago, IL area northern suburb of Deerfield. Consideration will also be given to remote work from a US location.

What You’ll Bring :

• Bachelor’s degree is required; Advanced degree or country equivalent; Masters and / or PhD will be an advantage
• Minimum of 12 years experience in Regulatory Affairs; experience with Class II or Class III medical devices ideal; PMA experience strongly preferred
• Minimum of 7 years of leadership experience to ensure team engagement; recruiting, hiring and retaining the best candidates;

managing employee performance; as well as mentoring and providing guidance to the team

• International experience / exposure preferred Japan experience is strongly preferred with extensive US FDA experience
• Exercises judgement independently
• Strong strategic skills including the ability to make complex decisions and willingness to support difficult positions
• Solid knowledge and understanding of global and US regulations and the US pharmaceutical commercial landscape
• Solid knowledge and understanding of complex medical and scientific subject matter as well as evolving regulatory policy and guidance
• Direct hands-on experience with preparation and submissions of IND, (s)NDA / BLA to US FDA
• Experience with labeling and PMC / PMR negotiations with US FDA
• Ability to work effectively in multinational / multicultural environment
• Sound basis of Scientific (Training / Communications) knowledge
• Excellent written and verbal communication, presentation, and facilitation skills
• Expert knowledge of regulations, current industry practices, and strong experience with interpretation and application
• Extensive familiarity with Industry and knowledge of forces impacting function
• Ability to lead, mentor, and develop others for future growth and development
• Proven negotiation skills and significant experience in interacting with regulatory authorities
• Established credibility with regulatory authorities
• Expert risk management skills

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