Technical Regulatory Team Member (CMC)

Job description

·  Job facts

Title: Technical Reg ulatory Team Member (CMC)

Department: Pharma Technical Regulatory (PTR)- Global

Location: Mississauga Campus

Objective:

In this role you are contributing to the development and execution of regulatory strategies, the sustainment of regulatory compliance at manufacturing sites, and the representation of PTR within internal functions and external groups. The focus of this role is on enabling global CMC-development leading to successful global commercial registration and/or effective management of post-approval changes and product life-cycle, including dossier preparation.

Responsibilities:

·  Responsible for submission of high quality CMC regulatory documents to global health authorities in accordance with current Good Manufacturing Practices (cGMP), Roche corporate standards and the requirements of applicable health authorities and other regulatory agencies.
·  Contributing to the timely regulatory approval of Roche products.
·  Actively contribute to the success of the technical regulatory team (TRT) objectives.
·  Support the development and communication of the regulatory strategy to ensure cross-functional alignment.
·  Help ensure cross-functional coordination and escalation, as needed.
·  Ensuring cross-functional PTR deliverables (including assignments delegated by the Technical Regulatory Leader(TRL)) are completed compliantly, accurately, thoroughly and in a high quality and timely manner.
·  Keeping the TRL fully apprised of project status and potential submission risks and impact to defined regulatory strategies and timelines.
·  Managing regulatory aspects of change control and ensuring appropriate communication to the TRT team regarding management of technical changes. Provide regulatory support for relevant quality systems such as change control, discrepancy management, as well as Health Authority inspection support as required and/or serving as a liaison with the local health authority on behalf of the site.
·  Contributing to regulatory excellence by identifying opportunities, mitigating risks and supporting continuous improvement.
·  Supporting TRT team in making clear decisions.
·  Supporting product related maintenance and Quality System activities as assigned (e.g., health authority commitments, health authority inspections, discrepancy assessments)
·  Support departmental business processes to document and improve best practices and work efficiencies.
·  Serving as a TRL designate or PTR regulatory compliance representative as requested by representing PTR on site, cross-functional, or leadership teams and boards. May act as TRL for programs of lesser comple
·  As applicable: Coordinate submission authoring as Submission Lead or Section Lead

Qualifications:

·  Bachelor’s Degree in life sciences is a minimum requirement and a Post Graduate Degree is preferred.
·  3 or more years’ work experience in the pharmaceutical, biotechnology or related industry in CMC Regulatory. Additional exposure to Quality, R&D, Manufacturing, Supply Chain Management or related would be a plus.
·  Experience and effectiveness leading strategic regulatory activities for product development from entry into humans through to life-cycle management and marketed products is a plus.
·  Experience participating in global product teams is a plus.
·  Experience as a contributor for global filings in the US or Europe is a plus.
·  Experience with medical devices is a plus.

T echnicalKnowledge

·  Knowledge ofregulationsandguidelines ofmajorregions(e.g. ICH,FDA,EMA,WHO) or access to expertknowledgefor otherregions.
·  Proficiencywith a widerange of data/information(CMC,clinical, non-clinicalsafety, DMPK, quality,manufacturing, business operationsin this area)

Qualified candidates please apply no later than September 17, 2020.

This position is not eligible for relocation support.

NOTE: All employment is conditional upon the completing and obtaining a satisfactory background check, including educational, employment, references and criminal records (for which a pardon has not been granted) checks.

Roche is an equal opportunity employer and prohibits unlawful discrimination based upon any legally protected ground. Roche will make a good faith effort to accommodate the individual needs of applicants with disabilities in our recruitment process

AGENCY NOTICE: Please note that Roche Canada does not accept unsolicited resumes from recruiters or employment agencies. In the absence of a signed Services Agreement with agency/recruiter, Roche Canada will not consider or agree to payment of any referral compensation or recruiter fee. In the event a recruiter or agency submits a resume or candidate without a previously signed agreement, Roche Canada explicitly reserves the right to pursue and hire those candidate(s) without any financial obligation to the recruiter or agency.

Roche is an equal opportunity employer.
Regulatory Affairs, Regulatory Affairs > General Regulatory Affairs

·  Who we are

Roche Pharma Canada has its office in Mississauga, Ontario and employs over 850 employees. The Mississauga facility is bright, vibrant, fosters collaboration and teamwork, and is reflective of Roche's truly innovative culture.

Roche is an equal opportunity employer.