Job Description

Are you looking to make a difference in a patient's life? At AmerisourceBergen, you will find an innovative and collaborative culture that is patient focused and dedicated to making a difference. As an organization, we are united in our responsibility to create healthier futures. Join us and Apply today!

What you will be doing

PRIMARY DUTIES AND RESPONSIBILITIES:

• Responsible for preparing client proposals and generating new business for TPIreg, including leading presentations to potential RA clients, and participating in multifunctional presentations
• Prioritize and manage multiple simultaneous projects to meet budget (including invoice review), timelines and client expectations; anticipate and resolve emerging issues
• Responsible for development and implementation of RA activities including assessments, strategies, submissions and agency interactions, applying expert knowledge in core area of regulatory practice (e.g., CMC, Medical Devices, CTAs, US etc.) and at least basic knowledge outside of core area
• Maintain target billables by obtaining new business
• Creates opportunities to build agency relationships by participating in professional activities such as offering industry training, conference presentations, publications and webinars
• Leads client and agency interface, with responsibility for strengthening relationships and growing the business. Responsible for the quality of deliverables, by ensuring compliance with Innomar and client review and approval processes; identifies and implements opportunities for process improvement
• Develop and maintain partnerships with senior decision-makers to build the business, resolve significant issues, and create opportunities
• Analyze data, the regulatory environment and business objectives to make and implement recommendations, using judgement to identify innovative solutions while managing unertainty.
• Lead and advise clients and cross-functional teams on agency interactions Leads decision-making and conflict resolution surrounding regulatory issues within cross-functional teams
• Proactively identifies, shares and interprets regulatory intelligence
• Manage multiple simultaneous projects to ensure that they are on budget, meet timelines and client expectations.
• Engages in continuous learning activities in order to provide effective consulting services and be a sought-after resource.
• Develop and manage 0-2 regulatory direct reports at Manager level or below, as assigned including but not limited to assignment delegation, time and budget management, skill and knowledge development
• Travel as required
• Other related duties as assigned

What your background should look like

EXPERIENCE AND EDUCATIONAL REQUIREMENTS:

B.Sc. degree in life sciences (Pharmacology, Molecular Biology, Biology, Chemistry or Pharmacy) or Engineering.

Advanced Degree in related field is preferred

12+ years of relevant experience in regulatory affairs or related functions in pharmaceutical/biologic/medical device development/manufacturing. In-depth experience in a designated area of specialization (e.g. Medical devices, clinical trials, CMC) may be required

Regulatory Affairs Certification (RAC) and other certifications are an asset

Prior consulting experience is preferred.

Leadership skills required

MINIMUM SKILLS, KNOWLEDGE AND ABILITY REQUIREMENTS:

Broad understanding of international regulations, processes and issues in drug/biologics/medical device development. Includes sound knowledge of ICH, Health Canada, FDA, EMA, and other relevant guidelines with focus in area of specialization such as CMC, biologics, pharmaceuticals, Clinical Trials, OTC/NHPs medical devices, or FDA..

In depth experience of successfully managing Health Authorities interactions on a regional basis

In depth regulatory expertise in the area of regulatory specialization required for the role, such as medical devices, CMC, or advertising/promotion

Extensive experience and working knowledge of a wide range of regulatory submission types.

Superior project management skills to manage multiple concurrent projects within established timelines in a dynamic environment

Advanced strategic planning and complex problem-solving skills to resolve complex issues with innovative solutions effectively and efficiently

Demonstrated senior leadership abilities in a cross-functional, multi-disciplinary team environment.

Ability to drive results in a team environment

Strong business and financial acumen

Strong analytical and mathematical skills

Ability to communicate effectively both orally and in writing;

Excellent presentation skills

Excellent leadership and interpersonal skills

Effective organizational skills; attention to detail

Ability to consistently meet deadline

Knowledge of computers, to operative effectively with Adobe Acrobat, Microsoft Word, Excel spreadsheets, and Microsoft Outlook Ability to develop professional networks that will drive business development and regulatory intelligence

What AmerisourceBergen offers

We offer competitive total rewards compensation. Our commitment to our associates includes benefit programs that are comprehensive, diverse and designed to meet the various needs across our associate population.

Throughout our global footprint and various business units, we take a balanced approach to the benefits we offer. Many benefits are company-paid, while others are available through associate contributions. Specific benefit offerings may vary by location, position and/or business unit.

Schedule

Full time

Affiliated Companies: Affiliated Companies: Innomar Strategies

Equal Employment Opportunity

AmerisourceBergen is committed to providing equal employment opportunity without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, age, disability, veteran status or membership in any other class protected by federal, state or local law.

COVID-19 Vaccine Policy

As of October 18, 2021, AmerisourceBergen requires all Canadian team members to be fully vaccinated and show proof of completed vaccine status at time of hire. If you cannot receive the COVID-19 vaccine due to a qualifying medical condition or sincerely held religious belief you will be required to follow AmerisourceBergen's policy and process to apply for an exemption/accommodation.

Accessibility Policy

AmerisourceBergen is committed to fair and accessible employment practices. When requested, AmerisourceBergen will accommodate people with disabilities during the recruitment, assessment and hiring processes and during employment.