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 Program Directors are assigned their responsibilities by moderate to higher complexity products, across varying product development phases, as business needs dictate.
Regulatory Labeling Program Directors are responsible for providing strategic and operational leadership for labeling of pharmaceutical products and devices, including the generation and revision of package inserts (USPI), and package labeling.
Associate Program Directors are expected to perform their responsibilities with increased independence.
EXAMPLE DUTIES AND RESPONSIBILITIES :
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
Leads and / or participates in the process for timely development, maintenance and revisions for product labeling for pharmaceutical products and devices, including :
Coordinating preparation of documentation package supporting proposed labeling changes
Communicating labeling changes to internal partners and stakeholders, including affiliates
Supporting the implementation of labeling changes into the local labels
Collecting and archiving the supporting documentation package for initial development and subsequent updates of labeling in appropriate internal database systems
Supporting creation and maintenance of systems that support labeling
Participates in ongoing RAFT meetings. Including providing ongoing expertise regarding regulatory labeling, guidance on compliance, timing and other relevant matters
Works collaboratively with 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 CML-specific Standard / Department Operating Procedures (SOPs / DOPs), systems, processes, or other relevant tools.
Includes efforts to build greater efficiency into the labeling process
As assigned, may precept / mentor interns and provide oversight on intern projects
Responsible for embodying a culture of compliance in all aspects of job performance. Completes required compliance training as assigned.
Identifies and escalates any potential compliance violations immediately to ensure they are addressed appropriately
QUALIFICATIONS & EXPERIENCE :
Bachelors Degree required (life sciences disciplines strongly preferred)
Advanced Degree in related field is preferred
Average of 5 or more years’ work experience in the pharmaceutical, biotechnology or related industry. Previous regulatory affairs experience, including labeling experience, is preferred
Demonstrated understanding of 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 is preferred
Familiar with competitive activity in the field
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
As required, ability to travel
Has impeccable ethics. Demonstrates, or has proven abilities to demonstrate, Roche Values & Leadership Competencies
Has sound knowledge and understanding of the multidisciplinary functions involved in pharmaceutical / biotechnology product development, clinical development, clinical operations, biostatistics, commercial operations, etc.
Excellent project management, organization and time management skills : has a track record of consistently meeting or exceeding assigned goals and objectives
Good interpersonal, verbal communication and influencing : can influence without authority
Good negotiation skills : knows how to complete deliverables by working effectively with others internally and externally
Strong written communication skills
Good judgment and decision-making skills : knows how to make trade-off decisions while balancing ethics and efficacy
Demonstrated orientation to teamwork : has been effective in the past working in cross-functional teams
Works well within teams and is effective in collaborating with others internally and externally