Senior Manager Regulatory Affairs

ICON is currently recruiting for a Senior Manager, Regulatory Affairs to join our Strategic Regulatory & Safety Consultancy group that forms part of a wider Commercialization and Outcomes group. Our regulatory consulting team serves clients around the globe—from biotech startups to big pharma—as well as the research firms that serve them. We’re headed by industry leaders who bring more than three decades of regulatory affairs experience to your projects. They, in turn, are backed by an unsurpassed team of more than 100 professionals and staff.

The Senior  Manager,  Regulatory Affairs  has  responsibility  to provide  comprehensive regulatory  services   for  clients  requiring   support for  registration  and  maintenance activities  in  for pharmaceuticals,  biologics, and other product types.  This role involves leading  the preparation,  filing  and  maintenance of regulatory  submissions  as well as management of clients. The work will entail primarily working with Health Canada submissions and assessments.

This role  is  responsible for ensuring  project/  program  timelines and budgets  are  met and maintaining  client  relationships  in  support of future  business.  The role  is responsible for support of activities to secure  new  clients/business.  This  position  may or  may not  have  direct  reports.

The primarily responsibilities of this job include:

•  Effectively-prepare    regulatory   files   and    provide    support   for   maintenance activities   in   adherence with   applicable   legislation,   and   guidelines facilitating approvals and continued client compliance. Assess and update clinical and non-clinical sections of the dossier to meet Canadian requirements.

• Manages  and  ensures  maintenance  of  a   positive  and   productive  liaison  with internal and external contacts, including regulatory agencies,  clients, and  related institutions.

• Lead/attend   formal   interactions   (face-to-face   meetings,   teleconferences,   etc.) with  clients  and,  government agencies. Prepare pre-submission meeting requests, packages, and priority-review requests.

• Develops  initial  or alternative  regulatory  strategies  consulting  with  other  resources  within  the  organization  as  needed.   Provide  clients  with strategic  advice  in  response  to their queries,  based on regulatory  experience  and area  of expertise.

• Responsible    for    managing    project   workflow    including    prioritizing    project objectives, and establishing timeframes for projects with clients.   Responsible for overseeing  progress  and  completion  of  projects  with  project  team  members, ensuring  timeframes  and  deadlines are  met.

• Lead, participate in and support project teams related to regional filings and maintenance activities  across  a range  of product types.

• Effectively    prioritize    and    complete    multiple    projects    within    established timeframes.

• Proactively monitors for new regulatory requirements and shares  key learnings.

• Train or mentor others to build team expertise across various  product types.

• This  role   will  prepare  quotations  for  projects  that  may  cross  multiple  service areas within the company and  manage projects within  budget preparing  change orders  as needed.

• Proactively improve business processes  and  tools to facilitate  provision  of core services.

• Ability to work  off site  at client occasionally may be needed.

• Ability to travel  (10%)  as necessary,  passport  required.

• Expectations  and  responsibilities  as outlined  in  the Mapi  Manager Job  Description if direct  reports  as assigned.

• Provide business development support and presentation of services to clients.

Required experience:

• Undergraduate degree preferably in science, nursing  or healthcare field or equivalent qualification/experience. Relevant advanced degree  (M.Sc., Ph.D.,  M.D.,  Pharm.D,  MBA) beneficial.
• Certification in regulatory affairs (RAC) or post-secondary  institution is beneficial.
• Minimum eight years of relevant experience i.e. pharmaceutical, biologics.
• Experience in consulting, supporting business development activities and people management is beneficial.

Benefits of Working in ICON

Other than working with a great team of smart and energetic people, we also offer a very competitive benefits package.  This varies from country to country so a dedicated recruiter will discuss this with you at interview stage.

We care about our people as they are the key to our success. We provide an open and friendly work environment where we empower people and provide them with opportunities to develop their long term career.   

What’s Next?

Following your application you will be contacted by one of our dedicated recruiters and if successful we will be able to provide you with more details about this opportunity.

ICON is an equal opportunity employer - Minorities/Females/Disabled/Veterans and committed to providing a workplace free of any discrimination or harassment.

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