Job Description

The Position

PDRL is part of the broader PDR organization that interprets the needs of worldwide health authorities and provides regulatory intelligence necessary to generate and present information that meets the needs of health authorities, patients, purchasers and prescribers for Roche\xe2\x80\x99s global Pharma Medicines Division, which includes all therapeutic areas and all phases of product development from early development to post-marketing. PDR is responsible for the timely submission of applications to health authorities for approval of new products and line extensions. PDR is committed to regulatory strategies that are the most innovative, ethical, and influential in the industry. Regulatory Labeling Associate Program Managers are assigned their responsibilities by products, across varying product development phases, as business needs dictate. Regulatory Labeling Associate Program Managers are responsible for providing strategic and operational leadership for labeling of pharmaceutical products and devices, including the generation and revision of global core data sheets (CDS), U.S. package inserts (USPI), and package labeling. Associate Program Managers are typically assigned less complex responsibilities and perform their work with increased supervision by comparison to Regulatory Labeling Program Directors. Associate Program Managers may also provide support to Regulatory Labeling Program Directors who are directly responsible for leading and managing PDRL activities.

Cross-Functional Teams

Participates in site, regional and/or global PDRL departmental meetings

As appropriate, may participate as a standing or ad hoc member in the Regulatory Affairs Functional Team (RAFT) for relevant, less complex products. When assigned, represents PDRL and supports effective and efficient cross-functional PDR coordination, appropriate resources, and timely, thorough and compliant execution

As needed, may advise as an ad hoc member in various teams, dependent upon assigned projects and the associated development phase, such as early development core teams, global development teams and lifecycle teams

As assigned, may act as a standing or ad hoc member of other teams for special or ongoing initiatives and projects

Regulatory Labeling

Stays abreast of internal and external developments, trends and other dynamics relevant to the work of PD and PDR to maintain, at all times, a fully current view and perspective of internal/external influences and/or implications for Roche therapeutic areas and products. Continues to expand his/her knowledge base of laws, regulations and guidelines governing the development, licensure and marketing of drugs and biologics

Obtains and applies in-depth knowledge of Roche and regulatory guidelines, procedures and best practices

Supports development of the cross-functional regulatory strategy for each product or related assignment by providing regulatory labeling expertise, insights, perspective and recommendations

Participates in and supports the process for timely development, maintenance and revisions for product labeling for pharmaceutical products and devices, including:

Coordinating preparation of documentation package supporting proposed CDS or USPI changes

Communicating CDS changes to internal partners and stakeholders, including affiliates

Supporting the implementation of CDS changes into the local labels

Tracking local label-CDS compliance and recording reasons for difference

Collecting and archiving the supporting documentation package for initial development and subsequent updates of CDS/USPI in appropriate internal database systems

Supporting creation and maintenance of CDS templates

Supports or otherwise compiles background packages (competitor labels, relevant guidelines, etc.) for internal labeling working group discussions

May participate in ongoing RAFT meetings. Including providing ongoing expertise regarding regulatory labeling, guidance on compliance, timing and other relevant matters

As requested, provides support to Regulatory Labeling Program Directors pre-and post- cross-functional meetings, other interactions and communications, which may include support in generating meeting minutes, distributing information, conducting post-meeting follow-up, etc

Supports or otherwise provides competitive labeling comparisons to RAFT and other USPI teams, as required for CDS/USPI preparation, submission and completion

Works collaboratively with global labeling personnel at other sites to ensure sharing of best practices and to enhance quality and consistency of processes

Participates in and/or otherwise supports development and implementation of new or updated PDR and/or PDRL-specific Standard/Department Operating Procedures (SOPs/DOPs), systems, processes, or other relevant tools. Includes efforts to build greater efficiency into the Promotional Review Committees (PRC) process

Other

May complete routine and ad hoc analysis and reporting. Responsible to keep all internal customers, partners and stakeholders abreast of progress and interim updates. Does so by following prescribed departmental procedures, practices and protocols and by using standardized reporting and communications tools/templates and other resources

Participates in other special projects, as and when assigned, or otherwise requested

Participates in routine and ad hoc departmental meetings and other business reviews or meetings to remain, at all times, fully abreast and apprised of evolving internal and external needs and requirements. Expected to share best practices within the department and cross-functionally, identify and communicate opportunities for departmental enhancements and efficiencies

Consistently complies with all governing laws, regulations, Roche SOPs and other guidelines

QUALIFICATIONS & EXPERIENCE:

Bachelors Degree required (life sciences disciplines strongly preferred)

Advanced Degree in related field is preferred

Average of 3 or more years\xe2\x80\x99 work experience in the pharmaceutical, biotechnology or related industry. Previous regulatory affairs experience, including labeling experience, is preferred

Demonstrated understanding of international regulations, processes and issues in drug/biologics development is preferred. Includes GxP (Good Practices for quality guidelines and practices in the pharmaceutical/biotechnology or related industry), GCP (Good Clinical Practice), ICH, FDA, EMEA, NICE and other relevant guidelines

Strong computer skills, including Microsoft Office Suite (Word, PowerPoint and Excel), Adobe Acrobat, relevant publishing and document management systems/software

Fluent English and other language skills as needed

ABILITIES:

Has impeccable ethics. Demonstrates, or has proven abilities to demonstrate,

Outstanding attention-to-detail

Has working knowledge of the multidisciplinary functions involved in pharmaceutical/biotechnology product development, e.g., clinical development, clinical operations, biostatistics, commercial operations, etc.

Excellent project management skills: can prioritize multiple tasks and goals to ensure the timely, on-target and within-budget accomplishment of such

Good interpersonal, verbal communication and influencing skills: can influence without authority

Strong written communication skills

Good business presentation skills: is comfortable and effective when presenting to others, internally and externally

Good negotiation skills: knows how to complete deliverables by working effectively with others internally and externally

Good judgment and decision-making skills: knows how to make trade-off decisions while balancing ethics and efficacy

Works well within teams and is effective in collaborating with others internally and externally

Ability to travel (
10%)

Who we are

At Roche, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we\xe2\x80\x99ve become one of the world\xe2\x80\x99s leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.

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.

As of January 4, 2022, Roche requires all new employees who work in Canada to be fully vaccinated against COVID-19 on the date they take office. This requirement is a condition of employment at Roche that applies regardless of whether the position is on a Roche campus or remotely. If you have a valid reason for not being fully immunized, which is limited to certain specific medical reasons or other valid reasons protected by applicable human rights laws, you may request an exemption and / or adaptation measures regarding this vaccination requirement.

Roche is an Equal Opportunity Employer.

Roche