Strategist, Regulatory Affairs Consultant

Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds….

ClinChoice is searching for a Regulatory Affairs Coordinator Consultant to join one of our clients.

ClinChoice is a global full-service CRO with a strong focus on quality, professional development, and supportive culture. As a client-facing role, we are looking for confident candidates with the ability to work independently whilst establishing a high-trust environment with the client’s counterparts.  

Main Job Tasks and Responsibilities:

OTC:

Establishment Registration (New and/or updates)

Product Registration (New and/or updates)

OTC Monograph Fee

OTC Amount reporting

Establishment and Product annual certification

Louisiana product Registration.

Cosmetics:

Facility Registration (New and/or updates)

Product (Formula) Registrations (New and/or updates)

Louisiana product Registration

Devices:

Facility and product registration (New and/or updates)

Facility and product annual certification.

SOPs (Local and Global)

Regulatory Affairs Management and Tracking of Post Marketing Commitments to Health Authority (Global)

1. Create, manage and distribute metrics.


2. Provide monthly reports to QPPV Office.

 Role of Global Regulatory Affairs to Support Product Registration/Notification and/or Launch (Global)

Direct Healthcare Professional Communications (DHPCs) (Global)

State Registrations (Board of Pharmacy State Registration)

1. QA representatives per site- Responsible for State Registrations


2. Supply Chain- budget


3. RA Compliance- I manage Contract and PO creation and Approve invoices

 US Legal Entity Simplification

15% INV Reduction, (Global)

Education and Experience:

• Minimum years of working experience in Regulatory Affairs in preparing and reviewing technical documentation and submissions per local regulations.


• Basic knowledge regulations (as applicable)


• Proficient in Microsoft Office (e.g., Word, Excel, PowerPoint).


• Fluency in English.


• Have a good understanding of current Good Documentation Practices in regulatory environment.


• Strong organizational skills including attention to detail, good planning and communication skills are required.


• Self-starter with ability to work in team environment and projects of diverse scope where analysis of a situation or data requires evaluation of various factors with minimal supervision.


• Must possess excellent written and verbal communication skills.


• Detail oriented with strong critical thinking and analytical skills and keen on producing results.

The Application Process

Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step.  Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.

Who will you be working for?

About ClinChoice    

ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services, with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific.           

Our Company Ethos

Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset and they are  the fulcrum around which all ClinChoice activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives all personnel the clear tools needed to manage both internal and client processes with the same methodology.   The success of these core values is evidenced by our below industry average turnover rates.

ClinChoice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent guided by diversity and inclusivity. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate it.

The following disclaimer for CA must be included (remove the equal opportunities wording from the advert template in the bottom paragraph and replace with the following):

ClinChoice Canada Inc. is proud to be an equal opportunity employer, valuing and respecting diversity.  We are committed to inclusive, barrier-free recruitment and selection processes. We will accommodate the needs of qualified applicants under the Human Rights Code and the Accessibility for Ontarians Disabilities Act, in all aspects of the hiring process, upon request by calling + 1 (647)724-5709 x 301. 

We thank all applicants for their interest; however, only those being considered for an interview will be contacted. In accordance with Federal Personal Information Protection and Electronic Documents Act ("PIPEDA") , personal information is collected under the authority of the Act and will only be used for candidate selection.