Senior Manager, Regulatory Affairs CMC
About the role
This vacancy has now expired. Please see similar roles below...
Senior Manager, Regulatory Affairs, CMC
ICON plc, a leading Clinical Research Organization, employing 14,500 people across 97 offices in 38 countries - our mission is to help our clients to accelerate the development of drugs and devices that save lives and improve the quality of life!
Location
The position may be remote across Canada or US, or a mixture of office and remote based.
We are looking for passionate, resilient, and inspiring individuals to join our Global Regulatory Affairs, Chemistry Manufacturing and Controls (RA, CMC) team, part of the Strategic Regulatory Services (SRS) group. SRS are a global team of regulatory strategists from (bio)pharma, consulting, CRO, and Agency backgrounds, with expertise in drug development, regulatory strategy and operational implementation, CMC, and Quality Services/QA.
As a Senior Manager, RA, CMC you will be responsible for working with clients to define and execute, technical and regulatory CMC strategy with and on behalf of clients, on a global basis.
Activities encompass early and late stage drug development, marketing application and approval, and product maintenance.
You will act as a regulatory expert both to clients and to the rest of the CMC team, often leading CMC strategy for clients to support registration (new and maintenance) in Canada the US, and internationally. You will also lead projects, ensuring on-time and on-budget delivery of project deliverables, as well as contributing to business development activities.
Responsibilities and Accountabilities
- Effectively manage/execute/oversee the preparation of regulatory CMC submission documents demonstrated by a deep knowledge of applicable legislation and guidelines for submission to government agencies and continued client compliance.
- Facilitate submission approvals and amendments through leading communications (face to face meetings, teleconferences, etc.) and negotiations with client, government agencies, and project teams. Build positive working relationships with clients, and government agency contacts.
- Actively anticipate and develop initial or alternative regulatory strategies, consulting with other resources within the organization as required. Provide clients with strategic advice in response to their queries, based on regulatory experience and area of expertise.
- Effectively manage workflow; prioritizing project objectives, and establishing timeframes for projects, as well as overseeing progress and completion of projects with project team members, ensuring timeframes and deadlines are met.
- Train, coach, and develop assigned individuals to build team expertise across various product types (technical CMC development, preparation of files, regulatory strategy, client management, agency/client communications and project management).
- Enthusiastically monitors for new regulatory requirements and shares key findings.
- Lead and/or participate in the preparation of quotations for projects that may cross multiple service areas within the company and manage projects within budget, preparing change orders as needed.
- Participate actively in other business related projects (business opportunities, client specific issues etc.)
Education/Experience
- Bachelors degree in a relevant discipline, preferably in a life sciences, or other healthcare field.
- Advanced degree (MSc., PhD., M.D., Pharm.D., MBA) in the biological, medical, chemical or engineering field may be beneficial.
- Relevant experience i.e. pharmaceutical, biologics with regulatory experience in the local environment
- Experience supporting business development activities and people management an asset.
- Certification in regulatory affairs (RAC) or post-secondary institution beneficial.
Application process
Once you find a job opening that fits your skills and interests, you can create an account, apply and check back on the progress of your application or apply for other roles. Once your application has been received, a confirmation email will be sent to your email.
Remember: this is our first time meeting you. Read the job description and highlight on your CV those experiences that we should learn about.
One of our experienced recruiters will read your profile and determine if you're fit for the role and the company. We are aware of instances where fake recruitment text messages and emails that can appear to come from ICON have been received by individuals. Always delete suspicious text messages or emails. Never give out personal financial information.
Reasonable AccomodationsDay in the life
Teaser label
Inside ICONContent type
BlogsPublish date
04/18/2024
Summary
Endometriosis Awareness: A Vital Cause In March, ICON, through its Networking Organization for Women (NOW) employee resource group, joined the global effort to raise awareness about endometriosis
Teaser label
IndustryContent type
BlogsPublish date
04/18/2024
Summary
Introduction to Data Management in Clinical Trials In the field of clinical research, data management plays a crucial role in ensuring the success and accuracy of clinical trials. Clinical trials
Teaser label
IndustryContent type
BlogsPublish date
04/12/2024
Summary
Introduction to the Clinical Research Supply Chain The clinical research supply chain plays a crucial role in the successful execution of clinical trials. It encompasses a complex network of activ
Who we are
Similar jobs at ICON
Salary
Location
Mexico, Mexico City
Department
Full Service - Development & Commercialisation Solutions
Location
Sao Paulo
Mexico City
Remote Working
Office Based
Business Area
ICON Full Service & Corporate Support
Job Categories
Project/ Program Management
Job Type
Permanent
Description
ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotech
Reference
JR118270
Expiry date
01/01/0001
Author
Ana LuciaAuthor
Ana LuciaSalary
Location
Mexico, Mexico City
Department
Full Service - Development & Commercialisation Solutions
Location
Mexico City
Remote Working
Office Based
Business Area
ICON Full Service & Corporate Support
Job Categories
Clinical Project Management
Project Management
Job Type
Permanent
Description
JR118149Laboratory Proj. CoordinatorSite: Mexico, Mexico CityOffice BasedAt ICON, it’s our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us
Reference
JR118149
Expiry date
01/01/0001
Author
Fernanda BezerraAuthor
Fernanda BezerraSalary
Location
Boston
Department
Clinical Operations Roles
Location
Boston
Remote Working
Remote
Business Area
ICON Strategic Solutions
Job Categories
Clinical Trial Support
Job Type
Permanent
Description
ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us
Reference
2024-109962
Expiry date
01/01/0001
Salary
Location
Poland
Department
Clinical Monitoring
Location
Poland
Remote Working
Remote
Business Area
ICON Strategic Solutions
Job Categories
Clinical Monitoring
Job Type
Permanent
Description
ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us
Reference
2024-109995
Expiry date
01/01/0001
Author
Michal CzyrekAuthor
Michal CzyrekSalary
Location
UK, Reading
Department
Full Service - Development & Commercialisation Solutions
Location
Reading
Swansea
Remote Working
Hybrid: Office/Remote
Business Area
ICON Full Service & Corporate Support
Job Categories
Project/ Program Management
Job Type
Permanent
Description
At ICON, it’s our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients’ lives. Our ‘Own I
Reference
JR119273
Expiry date
01/01/0001
Author
Hannah PetitjeanAuthor
Hannah PetitjeanSalary
Location
US, Salt Lake City (PRA)
Department
Full Service - Early Clinical and Bioanalytical Solutions
Location
Salt Lake City
Remote Working
Office Based
Business Area
ICON Full Service & Corporate Support
Job Categories
Nurse
Job Type
Temporary Employee
Description
At ICON, it’s our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients’ lives. Our ‘Own I
Reference
JR118252
Expiry date
01/01/0001
Author
Meris MyersAuthor
Meris Myers