Manager, Regulatory Affairs

- What you will be doing
Why choose Innomar Strategies_
- _ “Remote-First” culture - flexible opportunities to work from home_
- _ Competitive Total Rewards Package:_
- _ Base salary + bonus programs_
- _ RRSP matching_
- _ Employee Share Purchase Plan_
- _ Flexible benefits program (in effect on day one), including:_
- _ Healthcare Spending Account_
- _ Wellness Account - to focus on your nutrition, fitness, health and well-being_
- _ Parental Leave Top Up, 24/7 Employee Assistance Program, and Virtual Healthcare_
- _ Tuition Reimbursement + Employee Referral Programs_
- _ Growth opportunities for career advancement_
- _ Learning Programs, Leadership Training and Mentorship Programs to further your professional development_
- _ Ability to make an impact in creating healthier futures_
- _ We value diversity, equity and inclusion to foster a culture of belonging_
- PRIMARY DUTIES AND RESPONSIBILITIES:_
- Co-ordinate and compile high quality regulatory submissions, responses to agency questions and other correspondence in accordance with requirements for assigned projects
- Effectively prioritize, coordinate and complete multiple projects within established timeframes and budget.
- Maintain and expand professional regulatory knowledge (Health Canada, and U.S. FDA) in order to provide effective consulting services

Other Duties and Responsibilities:

- 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
- 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.
- Responsible for the quality control of documents and / or data, as required.
- Support of proposals to clients and other 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
- Participate in Agency interactions
- 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.
- Experience with Health Canada and/or FDA agency meetings an asset
- Certification in Regulatory Affairs (RAC) an asset.
- 5+ years Regulatory Affairs or related relevant experience within the health care products industry, or consulting
- MINIMUM SKILLS, KNOWLEDGE AND ABILITY REQUIREMENTS:_
- Strong working knowledge of Health Canada and/or FDA regulations, guidelines and policies
- Excellent interpersonal, verbal and written communication skills.
- Self-motivated and proactive
- Effective organizational skills; attention to detail
- Ability to consistently meet deadlines
- Direct experience and working knowledge of a range of health care products
- Excellent problem-solving skills; ability to resolve issues effectively and efficiently
- Demonstrated ability to work in a cross-functional, multi-disciplinary team environment.
What your background should look like
- 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
- 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._