Technical Regulatory Team Member

Job description

·  Job facts

Title: Technical Reg ulatory Team Member (CMC)

Department: Pharma Technical Regulatory (PTR)- Global

Location: Mississauga Campus

Hiring for 2 Levels:

Associate Technical Regulatory Team Member

Technical Regulatory Team Member

Multiple Positions Available!

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-approvals changes and product lifecycle including dossier preparation.

Responsibilities:

·  Responsible for submission of high quality CMC regulatory documents to 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 complexity
·  As applicable: Coordinate submission as Submission Lead or Section Lead

Qualifications:

·  Master's Degree in life science disciplines is preferred; Post Graduate Degree is a plus. Bachelor's Degree in pharmaceutical industry is also appropriate.
·  3 or more years' work experience in the pharmaceutical, biotechnology or related industry in CMC, Regulatory, 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 lifecycle management and marketed products is a plus.
·  International or global work experience 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.

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 applicants are encouraged to apply no later than February 21, 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

·  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.