Pharma Technical Regulatory Submission Manager

Job description

  Job facts

As Pharma Technical Regulatory Submission Manager you are part of the Pharma Technical Regulatory department in Pharma Technical Operations, Basel.

Behind every presentation of each product sold by Roche is the involvement of Pharma Global Technical Operations (PT). Starting with Phase I of the development process and continuing through to product maturity, PT makes medicines at sites around the world and includes more than 10 000 employees worldwide.

Pharma Technical Regulatory (PTR) provides the strategy, expertise and guidance to ensure world-class technical regulatory support for clinical trial applications, new molecular entity market applications, and post-approval change submissions. PTR's primary roles are to develop and implement technical regulatory strategies, to deliver Chemistry, Manufacturing and Controls (CMC) dossiers and to provide expertise to technical development and technical product teams. Furthermore, PTR collaborates with health authorities and industry groups and supports the relevant pharma quality systems.

Purpose of the position is to support PTR product managers by managing the flow of regulatory documents through the submission preparation and review processes. You will be editing complex, often lengthy technical documents for clarity, grammar, spelling and punctuation, for adherence to applicable regulatory (e.g., CTD) and Roche guidelines, and for consistency within the dossier. You will coordinate the flow of documents via document-sharing systems (e.g., SharePoint) and ensure version control throughout the submission generation process (writing, review, and internal approval).

In this role you will represent the Submission Management Group (SMG) in Technical Regulatory Teams and in Technical Development Teams, as well in cross-functional meetings, projects and initiatives, as needed, and collaborate with internal partners (e.g., regulatory publishing). In this context you will participate in SMG and PTR initiatives by providing input on future system enhancements, business process updates, and submission model documents.

Your main responsibilities include, but are not limited to:

·  Editing of regulatory documents
·  Support PTR product managers in generating submission timelines; plan and track submission generation activities, and evaluate submission-support strategies, as appropriate
·  Communicate with technical subject-matter experts to ensure that content is delivered according to schedule and to provide status updates. You will coordinate and provide training on documentation systems and tools, and you will collect relevant submission related data
·  Facilitate submission reviews and review adjudication meetings and perform live editing to capture stakeholders' decision

·  Who we are

Basel is the headquarters of the Roche Group and one of its most important centres of pharmaceutical research. Over 8,500 people from approximately 90 countries work in Basel, which is one of Roche`s largest sites. Read more .

Roche is an equal opportunity employer.

Desired profile

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.

You have a BA or BS (or equivalent) in English, Biology, Chemistry, Pharmacy, or a related field and a strong track record as an editor, including at least three years of professional editing experience, preferably in a scientific or technical field. Previous experience with regulatory documents (e.g., in CTD structure and other ICH, FDA, and EMA guidelines) and global submission dossiers or in the biotech or pharmaceutical industry is beneficial.

In addition you bring the following skills and competencies:

·  Tenacious attention to detail and consistency, especially with respect to grammar, usage, spelling, punctuation, and style; familiarity with standard style guides
·  Ability to communicate clearly and professionally, both orally and in writing, in English; German is a plus; ability to communicate in an international environment
·  Expert-level use of Word, Excel, PowerPoint, and Adobe Acrobat and experience with document management systems (e.g., Documentum) and document sharing systems (e.g., SharePoint)
·  Excellent teamwork skills and the ability to interface effectively with a wide range of stakeholders, including PTR submission leads, scientific subject-matter experts, reviewers at all levels within the company, and colleagues located in other countries
·  Strong organizational and time management skills; the ability to deliver under pressure; and the ability to work flexibly to support changing assignments and priorities in an independent and reliable manner

Please apply until: 12 November 2017.

·