Program Director, Regulatory Labeling at Genentech


Los Angeles
California, United States of America

The Position

GENERAL POSITION SUMMARY/PURPOSE:

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’s 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 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 global core data sheets (CDS), U.S. package inserts (USPI), and EU Annexes. Associate Program Directors are expected to perform their responsibilities with increased independence.
JOB DESCRIPTION – PRIMARY DUTIES AND RESPONSIBILITIES:

Intact &* Cross-Functional Teams

  • Participates in site, regional and/or global PDRL departmental meetings
  • As appropriate, participates as a standing or ad hoc member in the Regulatory Affairs Functional Team (RAFT) for relevant products. Represents PDRL and supports effective and efficient cross-functional PDR coordination, appropriate resources, and timely, thorough and compliant execution
  • As needed, advises 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
  • 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 CDS, USPI, and EU Annex 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/EU Annexes in appropriate internal database systems
    • Supporting creation and maintenance of CDS templates
  • Compiles background packages (competitor labels, relevant guidelines, etc.) for internal labeling working group discussions
  • Participates in ongoing RAFT meetings. Including providing ongoing expertise regarding regulatory labeling, guidance on compliance, timing and other relevant matters
  • Provides competitive labeling comparisons to RAFT and other USPI teams, as required for CDS/USPI/EU Annex 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
  • As assigned, may precept/mentor interns and provide oversight on intern projects

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 and/or otherwise leads 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

ABILITIES:

  • Has impeccable ethics. Demonstrates, or has proven abilities to demonstrate,
  • Outstanding attention-to-detail
  • Is regarded as a subject matter expert, is respected by others, and can effectively contribute to long-range product development
  • Strong business acumen: has in-depth knowledge of the pharmaceutical/biotechnology industry, the multiple functions and roles involved in the product development process
  • Excellent project management skills: can prioritize multiple tasks and goals to ensure the timely, on-target and within-budget accomplishment of such
  • Strong interpersonal, verbal communication and influencing skills: can influence without authority and has proven experience building and cultivating relationships with key partners and stakeholders, both internally and externally
  • Outstanding written communication skills
  • Strong business presentation skills: effective at summarizing and presenting the key considerations and decision-points
  • Confident and competent when interacting with varying levels of internal/external management: stays focused and on-point, is able to raise problems or challenges in a productive and mature manner
  • Strong negotiation skills: can effectively drive discussions and decisions toward desired end-results
  • Proven track record of effective decision-making: makes good business decisions and exercises sound judgment. Consistently and effectively balances decisions with imperatives for ethics and efficacy
  • Strong cross-functional teaming skills: has consistently excelled in cross-functional teams and regularly demonstrated him/herself as a leader among peers
  • Aptitude or proven ability to guide the work of others (can lead and motivate others, as well as prioritize and oversee their work through to successful outcomes)
  • Ability to travel (<20%)

QUALIFICATIONS & EXPERIENCE:
Candidates for this position should hold the following qualifications, have the following experience, and be able to demonstrate the following abilities to be considered as a suitable applicant. Please note that except where specified as “preferred,” or as a “plus,” all points listed below are considered minimum requirements.
  • Bachelors Degree required (life sciences disciplines strongly preferred)
  • Advanced Degree in related field is preferred
  • Average of 7 or more years’ work experience in the pharmaceutical, biotechnology or related industry. Previous regulatory affairs experience, including labeling experience, is preferred
  • Broad 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
  • 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
  • Previous people management (matrix management) experience is a plus
  • International or global experience is a plus
  • Fluent English and other language skills as needed

#LI-PDAB1
#ptcareers

Who We Are

A member of the Roche Group, Genentech has been at the forefront of the biotechnology industry for more than 40 years, using human genetic information to develop novel medicines for serious and life-threatening diseases. Genentech has multiple therapies on the market for cancer & other serious illnesses. Please take this opportunity to learn about Genentech where we believe that our employees are our most important asset & are dedicated to remaining a great place to work.
The next step is yours. To apply today, click on the "Apply online" button.
Genentech is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital & veteran status. For more information about equal employment opportunity, visit our .
Los Angeles
California, United States of America
  • Job Function

    Quality Compliance & Audit
  • Location

    • Los Angeles
      California, United States of America
  • Company/Division

    Pharmaceuticals
  • Schedule

    Full time
  • Job type

    Regular
  • Additional Locations

    • Mississauga
      Ontario, Canada

Remember to mention that you found this position on Graduateland