Job Description

Duration - 18 Months

The Submission Manager delivers high quality regulatory submissions to Health Authorities worldwide. They have responsibilities for varying regulatory submission projects, as business needs dictate. They apply submission management skills to their work and contribute to the daily business of Pharma Technical Regulatory submissions. They have the knowledge and ability to work with all submission types across Health Authorities globally

Primary duties and responsibilities :

Edit complex technical documents for clarity, grammar, spelling, and punctuation. Ensure adherence to applicable regulatory (e.g., CTD) and Roche guidelines

Support and provide coordination, compilation and submission management in the preparation of new and existing regulatory applications, in compliance with health authority regulations

A key member of local filing teams, provide ongoing expertise regarding regulatory submissions and guidance on compliance, timing and other relevant matters

Facilitates communication and collaboration to meet submission timelines and plan future requirements.

Manage the flow of documents via document-sharing systems (e.g., SharePoint) and document management-systems (e.g., Documentum) and ensure version control throughout the submission generation process (writing, review, and internal approval)

Communicate with technical subject-matter experts to ensure content is delivered according to schedule and provide status updates.

Coordinate and provide training on documentation systems and tools and collect relevant submission related data

Facilitate submission reviews and review adjudication meetings and perform live editing to capture stakeholders\xe2\x80\x99 decisions

Collaborate with internal partners (e.g., Regulatory Publishing, Project Management, Business Systems, etc.)

Providing input on future system enhancements, business process updates, and submission model documents

Additional Responsibilities

Facilitate knowledge sharing and best practice workshops contributing to continuous improvement

Lead or is an active member of teams for special or ongoing initiatives and project

Participates in and/or otherwise supports development and implementation of new or updated PTR and/or -specific systems, processes, or other relevant tools.

Includes supporting user acceptance testing for new or updated systems or electronic tools

Ability to travel and work internationally

Quality Related Job Accountabilities

Stays abreast of internal and external developments, trends and other dynamics relevant to the work of PT and PTR. Expected to develop and maintain his/her knowledge base of laws, regulations and guidelines governing the development, licensure and marketing of drugs and biologics.

Contributes to development and maintenance of policies and/or Standard Operating Procedures and related document management processes.

Ensure compliance with Roche standards, ICH, and other guidelines for incorporation into eCTD submissions

Follows regulations and company policies, and complies with all Roche Standard Operating Procedures

Demonstrates a continuous improvement mindset, with identifying and recommending opportunities to streamline or improve processes

Qualifications:

Minimum BA or BS (or equivalent) in English, biology, chemistry, pharmacy, or related field

Proficiency in RIM - Regulatory Information Management system - preferred but not mandatory

Strong track record as an editor , including at least three years of professional experience, in a scientific or technical field preferred but not mandatory

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

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 and colleagues located in other countries

Strong organizational and time management skills and ability to deliver under pressure and work flexibly to support changing assignments and priorities in an independent and reliable manner

Competencies & Skills

Strong written and verbal communication skills

Listens well and expresses ideas fluently and eloquently, is open to the input of others, can be depended on to tell the truth regardless of the circumstances

Understands the perspectives of different functional areas in the organization

Gathers information and thinks through problems clearly and logically, and makes timely decisions

Effectively manages change; explaining the context, answering questions, and patiently listening to concerns

Project management: consistently achieves multiple tasks and goals on-time

Proactively manages issues as, or before, they arise

Recognizes and rewards hard work and dedication to excellence (e.g., contributions of peers).

Fosters an exchange of ideas and support amongst colleagues

Able to help others link and prioritize their work with the mission of PTR and Roche

Articulates long-term objectives and strategies, and is good at promoting an idea or vision

Qualified candidates are encouraged to submit a cover letter and resume asap. This position will remain open 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.

Genentech is an equal opportunity employer, and we embrace the increasingly diverse world around us. Genentech prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin or ancestry, age, disability, marital status and veteran status.

Genentech requires all new hires to be fully vaccinated against COVID-19 as of their start date. This requirement is a condition of employment at Genentech, and it applies regardless of whether the position is located at a Genentech campus or is fully remote. If you are unable to receive the vaccine due to a disability or serious medical condition, or because it is prohibited as a result of your sincerely held religious beliefs, you will have an opportunity to request a reasonable accommodation.

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