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Regulatory affairs Jobs in Innisfil, ON

Last updated: 20 hours ago
Manager, Regulatory Affairs (Temporary Full Time)

Manager, Regulatory Affairs (Temporary Full Time)

CB CanadaOntario, Canada
CA$80,000.00–CA$100,000.00 yearly
Show moreLast updated: 30+ days ago
Manager of Environment & Regulatory Affairs

Manager of Environment & Regulatory Affairs

CSG TalentThunder Bay District, Ontario
CA$140,000.00–CA$163,000.00 yearly
Permanent
Show moreLast updated: 30+ days ago
Chief of Staff / Executive-Vice President, Medical Affairs, Niagara Health

Chief of Staff / Executive-Vice President, Medical Affairs, Niagara Health

Odgers BerndtsonNiagara, Ontario
serp_jobs.job_card.currency_salary_dayly
Show moreLast updated: 30+ days ago
Principal Technical Consultant, Biologist / Regulatory Specialist, Power and Renewables (Senior Level)

Principal Technical Consultant, Biologist / Regulatory Specialist, Power and Renewables (Senior Level)

The ERM International Group LimitedOntario, CA
CA$106,480.00–CA$132,250.00 yearly
Full-time
Show moreLast updated: 18 days ago
Director of Engagement

Director of Engagement

Royal Victoria Regional Health CentreBarrie, ON, CA
CA$67.30–CA$79.17 hourly
Show moreLast updated: 30+ days ago
Associate Director of Care | RAI Coordinator | RN |Temporary, Full-Time

Associate Director of Care | RAI Coordinator | RN |Temporary, Full-Time

Cedarvale Lodge Community and Retirement LivingKeswick, ON
Full-time
Quick Apply
Show moreLast updated: 14 days ago
Associate Director of Student Affairs (52638)

Associate Director of Student Affairs (52638)

International Education CorporationOntario, CA
CA$62,400.00–CA$80,000.00 yearly
Show moreLast updated: 30+ days ago
Community Engagement Advisor

Community Engagement Advisor

STRABAG INCON, Kanada
Full-time
Show moreLast updated: 8 days ago
  • Promoted
Chef de liaison médicale, SNC / Medical Science Liaison, CNS

Chef de liaison médicale, SNC / Medical Science Liaison, CNS

Otsuka Canada Pharmaceutical Inc.Ontario, Canada
Full-time
Show moreLast updated: 4 days ago
Manager, Regulatory Affairs

Manager, Regulatory Affairs

Innomar StrategiesRemote, ON
CA$151,600.00–CA$281,500.00 yearly
Remote
Full-time
Show moreLast updated: 30+ days ago
Associate Validation Engineer

Associate Validation Engineer

Sotera HealthON, Canada
CA$130,000.00–CA$160,000.00 yearly
Full-time
Show moreLast updated: 30+ days ago
Environmental Planner / Engineer

Environmental Planner / Engineer

Hydro One Networks IncON, CA
CA$500,000.00 yearly
Show moreLast updated: 30+ days ago
Director, Communications And Public Affairs

Director, Communications And Public Affairs

Meridia Recruitment SolutionsOntario
CA$39,040.00–CA$43,200.00 yearly
Show moreLast updated: 30+ days ago
  • New!
Wilfrid Laurier University Vice-President, Student Affairs

Wilfrid Laurier University Vice-President, Student Affairs

BoydenONTARIO, CA
Permanent
Show moreLast updated: 20 hours ago
Medical Scientist, HIV (Ontario)

Medical Scientist, HIV (Ontario)

Gilead SciencesOntario, Canada
CA$48.06–CA$54.91 hourly
Show moreLast updated: 30+ days ago
Manager Scientific and Regulatory Affairs Compliance and Innovation

Manager Scientific and Regulatory Affairs Compliance and Innovation

Coca ColaOntario,ON,Canada
CA$108,000.00–CA$126,000.00 yearly
Full-time
Show moreLast updated: 30+ days ago
Reporter

Reporter

Canadian Affairs News Inc.Ontario, CA
CA$32.00 hourly
Remote
Show moreLast updated: 30+ days ago
Director, Regulatory Affairs

Director, Regulatory Affairs

ParexelRemote, Ontario, Canada
Remote
Full-time
Show moreLast updated: 30+ days ago
Senior Medical Manager, Liver Diseases

Senior Medical Manager, Liver Diseases

Gilead Sciences Canada, Inc.Ontario, Canada
CA$76,499.00–CA$95,628.00 yearly
Full-time
Show moreLast updated: 30+ days ago
  • Promoted
General Manager

General Manager

Bass Pro ShopsNiagara, ON, Canada
Full-time
Show moreLast updated: 4 days ago
Manager, Regulatory Affairs (Temporary Full Time)

Manager, Regulatory Affairs (Temporary Full Time)

CB CanadaOntario, Canada
30+ days ago
Salary
CA$80,000.00–CA$100,000.00 yearly
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 :

  • Co-ordinate and compile regulatory submissions, responses to agency questions and other correspondence in accordance with requirements for assigned projects
  • Implement an agreed upon action plan to achieve timely approval of regulatory submissions which ensure compliance with applicable regulations, policy and guidance.
  • Participate in and support project teams
  • Effectively prioritize, coordinate and complete multiple projects within established timeframes.
  • Identify client and dossier issues and develop effective strategies to address them consulting with others as needed.
  • Build and maintain a positive and productive liaison with internal and external contacts, including interfacing with clients / agencies.
  • Pro-active project management skills to ensure that assigned projects meet budget / quote timelines and client expectations;
  • Responsible for the quality control of documents and / or data, as required.
  • Responsible for completion of other activities in support of products and processes as assigned
  • Maintain and expand professional regulatory knowledge (Health Canada and FDA) in order to provide effective consulting services.
  • Support of client proposals and new business activities as needed.
  • Train or mentor others to build team expertise.
  • Proactively improve business process and tools to expedite core services.
  • Ability to travel as necessary, passport required.

What your background should look like

EXPERIENCE AND EDUCATIONAL REQUIREMENTS :

  • B.Sc. (advanced degree preferred) in Life Sciences (Microbiology, Biology, Chemistry or Pharmacy preferred) or extensive equivalent experience and related training.
  • Certification in Regulatory Affairs (RAC) and / or Prior consulting experience an asset.
  • 5 - 8 years Regulatory Affairs or related relevant experience within the health care products industry, or consulting.
  • Experience with FDA submissions an asset
  • MINIMUM SKILLS, KNOWLEDGE AND ABILITY REQUIREMENTS :

  • Direct experience and working knowledge of a range of health care products
  • Strong working knowledge of local Health Authority regulations, guidelines and policies
  • Maintenance of work processes in line with customer needs and expectations.
  • Well organized, time management and multi-tasking skills.
  • Effective project management skills.
  • Excellent problem-solving skills; ability to resolve issues effectively and efficiently
  • Strong business and financial acumen
  • Strong analytical and mathematical skills
  • Self-motivated and proactive Effective organizational skills; attention to detail
  • Ability to consistently meet deadlines
  • Excellent interpersonal, verbal and written communication skills.
  • Demonstrated ability to work in a cross-functional, multi-disciplinary team environment.
  • Excellent computer skills with training in current software applications (MS Office, Adobe Professional).
  • 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.