Roche Singapore Technical Operations Pte Ltd

Senior / Regulatory Manager

Roche Singapore Technical Operations Pte Ltd Date Posted: 13-Nov-2017

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Job Nature:
Permanent
Position Level:
Experienced, Senior Manager
Job Category:
Qualification:
Bachelor's / Honours, Masters / PhD

Job Description

Responsibilities:
  • Provide regulatory support and oversight to the RSTO, Tuas facility as well as to regulatory products teams in support of regulatory submissions primarily to US FDA, in support of the scope of work assigned to Bio Marketed U.S. 
  • Lead site-specific regulatory submissions as well as product related regulatory submissions. 
  • Work closely with Roche Singapore Technical Operations (RSTO) Quality colleagues, technical and manufacturing key stakeholders, and the global PTR network to assure Genentech/Roche product and compliance to regulatory dossier are met. 
  • Provide regulatory support for the RSTO change management, discrepancy management quality systems, specifically, the incumbent will complete regulatory impact assessments for change control and discrepancies within the TrackWise system. 
  • Participate in Quality Review Boards and change review boards, as appropriate. 
  • Support timely compilation and submission of FDA notifications for significant issues as required.
  • Represent PTR during on-site health authority inspections as required. 
  • Lead US submissions and generate CMC regulatory submission information in support of product license applications/supplements, including participation in filing strategy development and readiness activities. 
  • Support and participate in communications with FDA as needed to facilitate review and approval of submissions. 
  • Assist with coordination of regulatory commitments related to the site. 
  • Provide regulatory support for RSTO manufactured products through close collaboration with PTR Technical Regulatory Leaders and regulatory product teams (TRT teams). 
  • Collaborate with regulatory product teams (TRT teams) in support of product activities such as technology transfer teams.
  • Lead and/or participate in cross-functional project teams and work effectively with multiple disciplines and across levels within the Roche organization. 
  • Additional responsibilities will include supporting and leading departmental operational excellence and business process initiatives, as well as proactively communicating with regulatory and cross-functional personnel in support of internal goals.

Who you are
You’re someone who wants to influence your own development. You’re looking for a company where you have the opportunity to pursue your interests across functions and geographies. Where a job title is not considered the final definition of who you are, but the starting point.

Requirements:
  • Minimum a Bachelor’s degree with at least 10 years or more experience in biotechnology and/or the pharmaceutical industry. 
  • Strong experience in Regulatory CMC as well as biologics manufacturing. 
  • Detail oriented with demonstrated strong leadership, interpersonal, and communication skills.
  • Able to work on flexible work schedule to accommodate the global nature of regulatory activities and associated time zones.   
  • Able to travel internationally, approximately 10% of the time per year.
  • Able to maintain a high level of professionalism, efficiency, and follow-through in support of the product and site work they support.
  • Possess a strong understanding of regulatory, regulatory compliance, and quality system requirements, and demonstrate effective problem solving, excellent interpersonal skills, and the ability to prioritize multiple tasks. 
  • Proven ability to communicate effectively in both a written and verbal format, and demonstrated effective partnering on projects and issue resolution.
  • Able to work both independently as well as collaboratively in a team structure, along with a proven track record of working well under pressure. 
Appointment to this position will be on local Singapore salary and benefits package.
Responsibilities:
  • Provide regulatory support and oversight to the RSTO, Tuas facility as well as to regulatory products teams in support of regulatory submissions primarily to US FDA, in support of the scope of work assigned to Bio Marketed U.S. 
  • Lead site-specific regulatory submissions as well as product related regulatory submissions. 
  • Work closely with Roche Singapore Technical Operations (RSTO) Quality colleagues, technical and manufacturing key stakeholders, and the global PTR network to assure Genentech/Roche product and compliance to regulatory dossier are met. 
  • Provide regulatory support for the RSTO change management, discrepancy management quality systems, specifically, the incumbent will complete regulatory impact assessments for change control and discrepancies within the TrackWise system. 
  • Participate in Quality Review Boards and change review boards, as appropriate. 
  • Support timely compilation and submission of FDA notifications for significant issues as required.
  • Represent PTR during on-site health authority inspections as required. 
  • Lead US submissions and generate CMC regulatory submission information in support of product license applications/supplements, including participation in filing strategy development and readiness activities. 
  • Support and participate in communications with FDA as needed to facilitate review and approval of submissions. 
  • Assist with coordination of regulatory commitments related to the site. 
  • Provide regulatory support for RSTO manufactured products through close collaboration with PTR Technical Regulatory Leaders and regulatory product teams (TRT teams). 
  • Collaborate with regulatory product teams (TRT teams) in support of product activities such as technology transfer teams.
  • Lead and/or participate in cross-functional project teams and work effectively with multiple disciplines and across levels within the Roche organization. 
  • Additional responsibilities will include supporting and leading departmental operational excellence and business process initiatives, as well as proactively communicating with regulatory and cross-functional personnel in support of internal goals.

Who you are
You’re someone who wants to influence your own development. You’re looking for a company where you have the opportunity to pursue your interests across functions and geographies. Where a job title is not considered the final definition of who you are, but the starting point.

Requirements:
  • Minimum a Bachelor’s degree with at least 10 years or more experience in biotechnology and/or the pharmaceutical industry. 
  • Strong experience in Regulatory CMC as well as biologics manufacturing. 
  • Detail oriented with demonstrated strong leadership, interpersonal, and communication skills.
  • Able to work on flexible work schedule to accommodate the global nature of regulatory activities and associated time zones.   
  • Able to travel internationally, approximately 10% of the time per year.
  • Able to maintain a high level of professionalism, efficiency, and follow-through in support of the product and site work they support.
  • Possess a strong understanding of regulatory, regulatory compliance, and quality system requirements, and demonstrate effective problem solving, excellent interpersonal skills, and the ability to prioritize multiple tasks. 
  • Proven ability to communicate effectively in both a written and verbal format, and demonstrated effective partnering on projects and issue resolution.
  • Able to work both independently as well as collaboratively in a team structure, along with a proven track record of working well under pressure. 
Appointment to this position will be on local Singapore salary and benefits package.

Company Overview

Roche Singapore Technical Operations Pte Ltd
Roche Singapore Technical Operations Pte Ltd
Roche Singapore Technical Operations Roche Singapore Technical Operations is Roche’s first biologics manufacturing site within Asia region, and the first company in Singapore to produce US FDA licensed bio therapeutics using recombinant DNA technologies. Our Vision and Mission We will be the most admired biotechnology production operation, respected for our world class innovation, engrained quality inspired people and operational excellence. Quality is every patient’s right and every employee’s responsibility. Quality provides a competitive advantage and is engrained in everything we do, from concept through continuous improvement. Because Roche’s products touch human lives, quality is the true measure of our success. The Business of Improving Human Lives With over 500 employees, two state-of-the-art facilities, using two different production technology platforms to manufacture bacterial and mammalian cell-based products – all within a 12.6 hectare biomedical space. Here