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Manager Regulatory Affairs

Req #: 1800005T_en
Location: Mississauga, ON CA
Job Category: Regulatory Affairs
Date Posted: 2/6/2018 2:51:50 PM
Baxter International

Description

Baxter provides a broad portfolio of essential renal and hospital products, including home, acute and in-center dialysis; sterile IV solutions; infusion systems and devices; parenteral nutrition; surgery products and anesthetics; and pharmacy automation, software and services. The company’s global footprint and the critical nature of its products and services play a key role in expanding access to healthcare in emerging and developed countries. Baxter’s employees worldwide are building upon the company’s rich heritage of medical breakthroughs to advance the next generation of healthcare innovations that enable patient care.

 

The Manager, Regulatory Affairs is responsible for:

 

Driving and leading Regulatory strategies for growth opportunities and product development in alignment with business priorities.

 

Utilizing a global perspective to build relationships with key advocates, regulators, and internal/external stakeholders to ensure that Baxter’s position is understood and given consideration to ensure product viability.

 

Coaching, mentoring and influencing cross functional teams to ensure a smooth transition of strategic plans related to Canadian initiatives and regulatory filings.

 

Lead communications and serve as a principle point of contact with senior management and business units as regulatory strategies are developed and implemented in order to achieve business success, while accounting for regulatory risks, opportunities, constraints and future changes.

 

Lead Canadian Regulatory Teams  to support the Regulatory vision and develop operational plans to support key product development projects as well as portfolio of existing products.

 

Lead multiple large scale submissions, including, management of deliverables from various functional areas to meet business goals.

 

Utilize expert technical regulatory skills of self and others to collaborate on strategies and influence Regulators on complex issues with significant future implications to global business decisions.

 

Lead risk identification, contingency planning and consensus building strategies for complex programs and ensure communication/ escalation of key areas of risk to reach favorable outcomes.

 

Apply understanding of scientific disciplines and methodologies to meet expectations of Regulators and effectively negotiate final outcomes based on analysis of data and rigor of scientific evidence.

 

Provide guidance and direction on complex or high risk projects and influence decisions at critical agency meetings to ensure a positive outcome.

 

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

 

Educate externally and influence Regulators about critical process/project standards and develop Baxter positioning.

 

Educate and influence internal stakeholders to adopt quality standards to meet regulatory requirements.

 

Oversee and successfully drive teams using clear, measurable and achievable goals to produce high quality submissions.

 

Coach, mentor and develop team members to excel at RA competencies and Baxter leadership expectations.

 

Manage lifecycle compliance, taking into account the possible evolution of the regulatory environment and business needs.

 

Effectively lead regulatory change management in close collaboration with Quality, Pharmacovigilance, Business Operations and successfully drive major continuous improvement initiative to completion.

 

Collaborate with Legal to provide perspective to legal interpretation.

 



Qualifications

Education Level

Required:

• Bachelor’s degree in a related scientific discipline

• Post Graduate Certificate in Regulatory Affairs

Preferred:

• Higher Degree will be an advantage

 

Major Subjects / Specialties

Required:

• Sciences (example: Chemistry, Biology, Pharmacology)

Preferred:

• Business

•  Project Management

 

Type of Experience

Required:

• Regulatory knowledge in the area of drugs/ biologics and medical devices

• Results-oriented with ability to work in an autonomous and proactive manner with skills to adhere to firm deadlines

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

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

• Thoroughness, commitment, attention-to-detail

• Excellent oral and written communication, and presentation skills

• Ability to accomplish results through others

• Ability to lead, coach and motivate others

• Strong Strategic and Problem Solving/Critical Thinking skills 

• Self-motivated with demonstrated leadership skills

• Working knowledge of cGMP requirements

Preferred:

• Expert Regulatory knowledge in the area of drugs, biologics and medical devices.

•  Expert knowledge of cGMP requirements

• Ability to generate innovative solutions to complex problems

• Working knowledge of electronic submission tools

• Demonstrated negotiation skills

 

Years of Experience

Required:

• Minimum of 5 years experience in Regulatory Affairs

• Record of achievement in area of responsibility and demonstrated success in interactions with regulatory authorities

• Minimum 3+ years of successful  people leadership experience

Preferred:

• Minimum7+ years of experience in the pharmaceutical and/or biologics industry dealing with regulatory issues and related industry matters

 

Additional Skills / Special Training / Technical Skills Required

Required:

• Business acumen

• RA and Agency knowledge

Preferred:

•  Business Excellence experience

•  Project Management Tools

•  Working knowledge and experience with computer  software applications for submissions

• Expert RA and Agency knowledge

 

A Career That Matters

Baxter’s employees are united in a mission to save and sustain lives. We are passionate about applying scientific innovation to meet the needs of the millions of people worldwide who depend on our medically necessary therapies and technologies. We focus on increasing access to healthcare, innovating in crucial areas of unmet need, and pursuing creative collaborations that bring our mission to life for patients every day.
 
Thank you for your interest and application to Baxter.  All applications will be reviewed and those candidates selected for consideration will be contacted directly.
 
Baxter is committed to creating and maintaining a barrier-free environment for all employees and customers. We believe in integration and equal opportunity and we are committed to treating all people with dignity and respect.

 
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