Manager Regulatory Affairs
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.
• Bachelor’s degree in a related scientific discipline
• Post Graduate Certificate in Regulatory Affairs
• Higher Degree will be an advantage
Major Subjects / Specialties
• Sciences (example: Chemistry, Biology, Pharmacology)
• Project Management
Type of Experience
• 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
• 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
• 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
• 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
• Business acumen
• RA and Agency knowledge
• 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