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.



Summary



The Global Regulatory Lead of the Baxter Pharmaceuticals Global Business Unit (GBU) is responsible for strategic direction, regulatory innovation and lifecycle management for the portfolio of products within this GBU, including biosimilar, combination products, conventional and complex generic injectable and compounded products. The lead is a key member of the Global Pharmaceuticals Leadership Team. Therapeutic areas include anaesthesia, anti-invectives, cardiology, and oncology products.



This position will collaborate with R&D, clinical, manufacturing, quality, business and regulatory teams around the world to ensure strategic and operational objectives are met. The role provides regulatory strategic oversight and utilizes the successful candidates technical expertise and leadership skills to guide a team of highly skilled and experienced regulatory professionals. S/he will provide results-oriented leadership focused on maximizing developmental opportunities in a collaborative manner. This position will provide the opportunity to be a true business partner to the GBU, while being a change agent committed to unlocking organizational potential through strategy and development initiatives. S/he will have the mandate to continuously upgrade core competencies of the regulatory organization as part of the Regulatory Leadership Team.





Essential Duties and Responsibilities



* Primary regulatory leadership role for the Baxter Pharmaceutical Global Business Unit (GBU); member of Global Pharmaceuticals leadership team

* Utilize expert technical regulatory skills and experience to collaborate on strategies and influence regulators on program issues with impact for Baxter

* Set global regulatory strategy for complex programs and/or interrelated portfolios

* Guide, direct, and manage regulatory professionals in development of global strategic plans and executing global regulatory submissions for new products

* Accountable for ensuring that regulatory submissions meet appropriate standards and content requirements

* Assess competitive influence on development programs and adapt strategy

* Provide subject matter experience and expertise for due diligence assessments

* Escalation point for regulatory related issues globally for the GBU

* Manage GBU RA staff. This includes goal setting, talent development and identifying appropriate performance measures

* Act as liaison to ensure alignment with other parts of the regulatory organization (Regions and Shared Services)





Education and Experience



* Advanced Degree or country equivalent in related scientific discipline

* Pharm.D. or Ph.D. will be an advantage



* Minimum of 12 years of experience in RA, including at least 5-7 years of experience leading teams and managing people

* Track record of managing product development of complex sterile generic injectable drugs and biosimilars

* Track record of successful negotiations with regulatory agencies resulting in timely and accelerated product approvals

* Significant experience with submissions and approvals of ANDAs and 505(b)2 applications (and international equivalents)

* Experience with submissions and approvals of 351(k) biosimilar applications (and international equivalents) is a plus

* Global submissions experience required including successful submission and approval of product license applications and other dossiers

* Experience supporting investigational products and regulatory filings (INDs, CTAs), including development of clinical trial protocols required

* Experience with combination products and drug compounding preferred

* Strategic and technical expertise required to develop and guide execution of global regulatory strategy for CMC issues

* Established credibility with regulatory authorities.

* Expert knowledge of regulations, current industry practices and experienced application of same

* Strategic thinker capable of executing on strategy across entire portfolio; demonstrated success in setting regulatory strategy and in obtaining worldwide product approvals

* Ability to manage complex issues and provide guidance to subordinates, peers and senior management on product development strategies through all stages of the product development cycle

* Solid basis in scientific approach and an ability to deal with in depth technical information for a variety of disciplines and to foster a high degree of scientific credibility, both within the technical community inside the organization and with regulatory agencies.

* Demonstrated ability to maintain positive and proactive collaborations cross-functionally with line functions; to bring about change and manage and mentor high level team members and serve as a champion for others success

* Flexible, positive and creative thinker with the proven ability to develop and implement innovative programs and processes; competence in researching and solving problems

* Inspirational, organized leader who sets clear goals and standards of accountability.

* Team player, who understands that success is only possible in conjunction with departmental and cross functional peers.

Equal Employment Opportunity

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.

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Reasonable Accommodations

Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please send an e-mail to [email protected] and let us know the nature of your request along with your contact information.