Regulatory Affairs Manager

PUB325439

About this role: Regulatory Affairs Manager

About this role: Regulatory Affairs Manager

IntroductionWe have an exciting new role that just popped up for one of the big 5 Global Pharmaceutical companies for a 6-month contract.
This role would be perfect for someone who:
Doesn't mind working a contract but also wouldn't mind if the role became full time and perm
Is looking to make a step up in their career but sees no growth in their current companyLooking to work one of the biggest pharma companies in the world
Is just looking for a change, new environment and needs to shake it up a littleSomeone who retired and still wants to stay relevant to what's going on in their field.
Likes to work remotely but is also okay with the possibility of it evolving into a hybrid model (Mississauga area)
Key Client Attributes: (some of our MUST haves)- with SOME room for flexibility
Has worked with all 5 modules of regulatory CMC submissions
Someone with experience with Clinical Trial Applications, post-market changes, for RX and Biological drugs.
Someone who is able to challenge their submission and provide Health Canada with some alternative solutions should they say "no"
Experience with Biologicals and vaccines would be a strong asset. Not just natural health or food
They are also open to whatever salary you're open to (how awesome is that?)

· Develops regulatory strategies for rapid approvals with optimal labeling for products within therapy or for submissions within the specialization area
· Accountable for a portfolio of products, including the preparation, filing and approval of regulatory submissions (NDSs, SNDSs, CTAs, NCs, etc) to aggressive targets
· Ensures compliance with applicable Health Canada, industry, and codes and guidelines in alignment with business needs
· For Therapy Area: Builds trust with Health Canada contacts to improve submission approval times, achieve competitive labeling and resolve product-related issues impacting submissions, or compliance activities
· For CMC: Builds trust with Health Canada contacts to improve submission approval times and resolve product-related issues impacting submissions, supply continuity, or compliance activities.
· Communicates with and influences multiple local and global functions, to achieve regulatory objectives
· Identifies and responds to issues related to assigned projects and/or products
· Interprets Canadian regulations, guidelines, and policies as they apply to regulatory activities
· Mentors junior staff

Requirements

Requirements

Qualifications Required:
· B.Sc. in life science or relevant scientific field (e.g. pharmacology, toxicology, chemistry)
· CRITICAL ** For Therapy Area: Extensive Canadian regulatory affairs experience leading multiple submissions at all stages of the product lifecycle
· CRITICAL ** For CMC: Extensive Canadian CMC Regulatory experience leading multiple submissions at all stages of the product lifecycle. Experience with small molecules, vaccines, and other biologics is an asset.
· Must possess a thorough understanding of the Canadian Food & Drug Regulations, relevant guidelines and policies
· Must possess a thorough understanding of drug development and commercialization process
· Highly innovative (strategic and functional) and creative problem solver and decision-maker who can apply continuous improvement techniques to gain efficiencies in submission preparation, product approval process, and resolving issues
· Agile and able to effectively navigate change
· Demonstrated ability to develop effective regulatory strategies aligned with commercial objectives
· Working knowledge of global regulatory agencies and their practices
· Excellent oral and written communication skills including the ability to present information and contribute ideas in small and large groups
· Good influencing and relationship management skills
· Excellent negotiation skills
· Fully developed project management skills
· Must act with integrity and demonstrate a strong and effective risk management perspective
· Ability to provide and receive feedback, raise issues, share experiences and lessons learned.
· Proactive and seeks to constantly learn and develop, ensures that skills meet changing business needs
· Fosters strong team collaboration, with the ability to engage constructively with others and demonstrate a positive mindset. Open to diverse ideas, styles and perspectives.
· Strong commitment to quality mindset
· Strong computer literacy and computer skills including Word, Excel, PowerPoint, Outlook

Benefits

Benefits

What We Offer
Why work with Brunel? We are proud to offer exciting career opportunities from over 100 offices globally in 42 countries. Advancing your career takes time and effort – let us match you to your ideal position.

Join the Brunel Family

Career interview session

Join the Brunel Family

Brunel has a reputation for working with some of the best in the business. That’s what we continually strive for. Over 45 years, we’ve created a global network of interesting clients and talented individuals working together through a vast array of services.

Start applying immediately

Start applying immediately

Sending an application is quick and easy. Just make sure you have the required documents ready to go.

  • Certifications (optional)
  • Job references (optional)
  • Motivation Letter (optional)
  • Resume or up-to-date LinkedIn / Xing profile
Apply now

Any questions remaining?

Your consultant, Sabrina Morris is happy to clarify anything about this vacancy. When reaching out, use the pub number:
PUB325439

Account manager

Sabrina Morris
Brunel Canada - Calgary
s.morris@brunel.net

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