Technical Regulatory Leader (CMC)

Canada, Ontario, Mississauga

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Title: Technical Regulatory Leader (CMC)

Department: Pharma Technical Regulatory (PTR)- Global

Location: Mississauga Campus

Multiple Positions Available!

Objective:

In this role you are responsible and accountable for leadership in the development and execution of regulatory strategies and represent PTR within internal functions and external groups. The focus of the Technical Regulatory Leader (TRL) is on enabling global CMC development, dossier preparation and regulatory risk mitigation leading to successful clinical trial applications, global commercial registration and/or effective management of post-approvals changes in consideration of business needs and life-cycle management for the specific program.

Responsibilities:

  • Accountable for development, communication and execution of sound regulatory strategies that meet global regulatory requirements and enable business objectives, including identification and communication of regulatory risks and development and execution of risk mitigation strategies in concert with technical functions.
  • Act as a single point of contact with knowledge of the global Chemical Manufacturing Controls (CMC) regulatory requirements.
  • Accountable 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.
  • Effective management of regulatory changes through the product lifecycle. Provide regulatory support for relevant quality systems such as change control, discrepancy management, as well as Health Authority inspection support as required.
  • Ensuring cross-functional alignment on regulatory strategies
  • Coordinating and/or leading health authority interactions for assigned projects; representing Technical Regulatory at multidisciplinary meetings with health authorities.
  • Representation of PTR on other cross-functional teams, such as Technical Development Teams (TDTs), Technical Product Teams (TPTs) and Regulatory Affairs Functional Teams (RAFTs).
  • Responsible for project planning, scheduling, resourcing and communicating of project updates to PTR Management and External Stakeholders for the team.
  • Contributing to regulatory excellence by identifying opportunities, mitigating risks and supporting continuous improvement. Driving and making clear decisions in the project team environment.
  • If applicable, leading a Technical Regulatory Team (TRT) of one or several technical regulatory professionals (depending on complexity of the program. The TRL effectively delegates to team members and compiles the resource needs for centralized planning. Provides timely performance feedback to GL/managers; aligns where possible the development goals of team members with the project activities.
  • Support departmental business processes to document and improve best practices and work efficiencies.

Qualifications:

  • Master’s Degree in life science disciplines is preferred; Post Graduate Degree is a plus. Bachelor’s Degree plus appropriate working experience in pharmaceutical industry is also appropriate.
  • 5 or more years work experience in the pharmaceutical, biotechnology or related industry as appropriate and CMC, quality, regulatory or related experience.
  • Proven experience and effectiveness leading strategic regulatory activities for product development.
  • Experience in the principles of data analysis, interpretation and clinical relevance.
  • International or global work experience is a plus.
  • Experience participating in global product development teams is a plus.
  • Experience as a regulatory contributor for global original filings in the US or Europe is preferred; for marketed products, experience as a submission lead for complex global changes filed in EU or Europe is preferred.

Technical Knowledge

  • Advanced knowledge of regulations and guidelines of major regions (e.g. ICH, FDA, EMA, WHO) or access to expert knowledge for other regions.
  • Advanced proficiency with a wide range of data/information (CMC, clinical, non-clinical safety, DMPK, quality, manufacturing, business operations in this area)

This posting will remain opened until all roles are filled.

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