Manager, Regulatory Affairs (Temporary Full Time)

CB Canada; Ontario; On-site; CAD 60,000 - 95,000; Full time

Job summary

An established industry player is seeking a dedicated Regulatory Affairs Specialist to join their innovative team. In this role, you will coordinate regulatory submissions and ensure compliance with health authority regulations. Your expertise will help shape the future of healthcare products, making a significant impact on patient lives. The ideal candidate will have a strong background in life sciences and project management, with excellent problem-solving and communication skills. This is a fantastic opportunity to work in a collaborative environment where your contributions will be valued and recognized.

Benefits

Comprehensive benefit programs

Competitive total rewards compensation

Diverse benefits tailored to associates' needs

Qualifications

• 5-8 years of experience in Regulatory Affairs or related fields.
• Strong knowledge of Health Authority regulations and guidelines.

Responsibilities

• Coordinate regulatory submissions and responses to agency questions.
• Implement action plans for timely approval of submissions.

Skills

Regulatory Affairs

Project Management

Problem-Solving

Communication Skills

Analytical Skills

Education

B.Sc. in Life Sciences

Certification in Regulatory Affairs (RAC)

Tools

MS Office

Adobe Professional

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.
• 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

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.

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.