Regulatory Affairs Associate
Regulatory Affairs Associate
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Salary Not Disclosed
1 Vacancy
Job Description
At Roche you can show up as yourself embraced for the unique qualities you bring. Our culture encourages personal expression open dialogue and genuine connections where you are valued accepted and respected for who you are allowing you to thrive both personally and professionally. This is how we aim to prevent stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche where every voice matters.
The Position
Job Title: Regulatory Affairs Associate
Location: Mississauga Campus Hybrid
A healthier future. Its what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come. Creating a world where we all have more time with the people we love. Thats what makes us Roche.
The Regulatory Affairs Chapter is committed to ensuring patients have access to improved outcomes more quickly. Our strategic focus is on building submitting and obtaining authorizations for clinical trial applications New Drug Submissions and new indications. Additionally we collaborate with external partners to shape regulatory policies that eliminate barriers enabling faster access to medications and therapies for patients.
The Regulatory Affairs Associate role is an integral part of the Regulatory Affairs Chapter working strategically and collaboratively across local and global networks to file timesensitive postNOC safety labelling and chemistry and manufacturing (CMC) submissions to Health Canada. This role is also responsible for leading special projects aimed at enhancing processes driving change management and actively participating in regulatory consultations and modernization initiatives.
We are currently seeking a collaborative and motivated individual to join our team as a Regulatory Affairs Associate. In this role you will be responsible for the strategic planning and timely preparation and approval of postauthorization changes (Supplemental New Drug Submissions Notifiable Changes Level III/IV changes) and support various components of New Drug Submission filings. Your responsibilities will also involve collaborating and actively participating with local and global crossfunctional submission teams and contributing to the development and maintenance of local Standard Operating Procedures (SOPs) process maps and operating guides aligned with Canadian regulatory requirements. Additionally you will stay updated on relevant systems used for regulatory filings and support crossfunctional processes.
The Opportunity
You are accountable for planning strategizing preparing and managing timely approvals as necessary for safetyrelated submissions such as safety label updates in line with CDS DHCPs/DILs Risk Management Plan preparation and maintenance PBRER submissions reporting of foreign action as well as supporting promotional material reviews.
You are accountable for planning strategizing preparing and managing timely approvals as necessary for chemistry and manufacturing (CMC) submissions impacting the Certified Product Information Document (CPID) QOS and Module 3 lead Yearly Biologics Product Report (YBPR) preparation and filing and conduct environmental monitoring.
You lead or support preparation and of presubmission meetings with Health Canada as necessary.
You review artwork for product packaging including inner and outer labels and the package insert for compliance with Canadian requirements
You maintain uptodate knowledge of and work within internal regulatory systems and platforms used for compliance tracking to efficiently execute daytoday activities and support crossfunctional processes.
You actively engage with the Regulatory Affairs Associate team and the Regulatory Affairs chapter and are comfortable speaking up and challenging when necessary.
You work collaboratively sharing expertise within the Regulatory Affairs chapter and across the organization to eliminate silos and duplication ensuring efficient use of skills.
You lead and manage implementation of improvements to regulatory processes for more efficient and successful regulatory submissions.
Who you are:
You hold a Bachelors Degree in a sciencerelated field and possess a minimum of 5 years work experience in the pharmaceutical/biotech industry in Regulatory Affairs.
You have indepth knowledge of Health Canada regulations and guidelines with experience executing Canadian submissions. Additionally knowledge of the EU and FDA regulations and guidelines are an asset to understand where the Canadian regulations align or contrast.
You have the necessary knowledge of Microsoft Office and Google Suite
Preferred:
You have a Pharmacy degree or hold a Masters degree or Graduate certificate in Regulatory Affairs
You demonstrate strong communication and problemsolving skills
You have experience in process management planning and strong ability to meet tight deadlines
You demonstrate the ability to collaborate and work as a team
You demonstrate an enterprise mindset and the ability to work effectively across crossfunctional areas in a fastpaced environment.
Relocation benefits are not available for this position.
Who we are
A healthier future drives us to innovate. Together more than 100000 employees across the globe are dedicated to advance science ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities foster creativity and keep our ambitions high so we can deliver lifechanging healthcare solutions that make a global impact.
Lets build a healthier future together.
Roche is an Equal Opportunity Employer.
Required Experience:
IC
Employment Type
Full-Time
