Associate Director, Regulatory Affairs: Labeling

10 Jul, 2022

Jobs

Associate Director, Regulatory Affairs: Labeling

Novavax
Gaithersburg, MD

Job Details

Description

**Except where prohibited by applicable state law, this position requires that you be fully vaccinated against COVID-19 unless you need a reasonable accommodation or qualify for an exemption.**

If you find science, speed, and success exhilarating, you have come to the right place.

Novavax, Inc (Nasdaq:NVAX) is a biotechnology company that creates transformational vaccines that address some of the world’s most pressing infectious diseases.  We have more than a decade of experience contending with some of the world’s most devastating diseases, including COVID-19, seasonal influenza, RSV, Ebola, MERS, and SARS. Hard-won lessons and significant advances illustrate that our proven technology has tremendous potential to make a substantial contribution to public health worldwide.

Our scientists are committed to developing vaccine candidates for some of the world’s toughest viral threats by utilizing the power of our innovative recombinant nanoparticle vaccine platform.  Our vaccine technology combines the power and speed of genetic engineering with the immunogenicity enhancing properties of our Matrix-M™ adjuvant to efficiently produce highly immunogenic particles targeting some of the most pressing viral infectious diseases.

Novavax, Inc. is headquartered in Gaithersburg, Maryland with additional facilities in Uppsala, Sweden and Bohumil, Czech Republic.

Summary of the Position:

We are seeking a highly motivated and experienced individual for an Associate Director position with experience leading daily operations for a global labeling group within the Regulatory Affairs organization. This position will report to the Director, Regulatory Affairs: Labeling. The Associate Director, Global Labeling is responsible for the leadership and oversight of the Labeling function within Global Regulatory Affairs (GRA).  This position will provide expertise on regulations governing the labeling of products globally and will actively contribute to the development and implementation of regulatory labeling strategy. In this role, the Associate Director will provide strategic input into the development and approval of company product Company Core Data Sheets (CCDSs) and country/ regional labels and will lead teams in the development of labeling documents for pre- and post-marketed products. This position will also be responsible for the oversight of assigned labeling operations and the Labeling Manager and Specialist team.

Location: Fully Remote/ Hybrid

Major tasks and responsibilities include but are not limited to:

  • Leads cross-functional teams in the timely development of content for all new or revised CCDSs and local labeling for assigned products and countries/regions in various vaccine areas.
  • Authors new or revised CCDSs and local product labeling (i.e., assimilates relevant clinical and scientific information into the product labels), obtaining input and approval from all relevant functional areas with appropriate annotation and supporting documentation.
  • Contributes to the development of Regulatory strategy for all labeling variations and supplements to ensure labeling is globally and regionally aligned.
  • Ensures tracking for labeling updates and the timely distribution/implementation of core and local country product labeling (e.g., for safety changes in local labels, posting to internal and local databases, SPL submissions, etc).
  • Ensures submission readiness activities for labeling, including translations, are aligned with submission content plans and are completed within timeframes for different procedure types (e.g., US Changes Being Effected (CBEs)/Prior Approval Supplements (PASs), EU Type I/II post-approval variations, etc.).
  • Ensures labeling updates for periodic aggregate reports are accurate and provided within timeframes.
  • Acts as a liaison between SMEs, company stakeholders and partners in the labeling process.
  • Accountability for establishing and maintaining processes and standards for global labeling.
  • Ensure a centralized labeling repository within electronic document management system (eDMS) is maintained per procedures for all global labels at various stages of development, review, and approval.
  • Supervises Labeling Managers and Specialists to effectively operationalize labeling activities; develops and mentors direct reports on both operational and strategic aspects of labeling.
  • Oversees and contributes to content reviews and QC checks for artwork control and approval.
  • Ensures consistency of labeling globally and compliance with company policies, procedures and applicable regulatory authority requirements and regulations.
  • Analyzes competitor labeling to determine precedence and ensure company products have most competitive labeling.
  • Continuously develops and maintains expertise regarding key labeling requirements and comparator updates globally and educates/guides authoring team and reviewers with this knowledge.
  • Represents regulatory strategy when interacting with GRA and other workstreams or project teams.

Minimum requirements:

  • Bachelor’s degree preferably in a scientific field. An advanced degree is desirable.
  • A minimum of 8 years in the drug development industry with 4-6+ years in Regulatory Affairs with focus on labeling expertise.
  • Pharmaceutical industry knowledge across key functional areas relevant to labeling (e.g., Regulatory Affairs, Regulatory Operations, Clinical Operations, Manufacturing, Quality Assurance, Supply Chain, Advertisement and Promotional Review, and Marketing).

Key Skills and Competencies:

  • Proficient knowledge of global/regional regulations and guidelines pertaining to labeling and demonstrated ability to decipher and understand implications of label changes on pending and approved labels across the regions.
  • Demonstrated ability to understand how updating one section of a label may impact another and to propose recommendations to the Labeling Team.
  • Proven understanding of the dynamics and purpose of CCDSs, Company Core Safety Information (CCSI).
  • Excellent communication skills (oral, written, and interpersonal); critical-thinking and ability to identify and recommend solutions to problems.
  • Adept at navigating eCTD file structure and referencing data within eCTD Modules and within reports
  • Excellent verbal and written communication skills required
  • Attention to detail and proofreading skills required.
  • Experience using an electronic document management system (e.g. Veeva Vault) is preferred.
  • Demonstrated project management skills with the ability to prioritize and ensure multiple projects are progressing.
  • Demonstrated knowledge of GXPs
  • Ability to develop strong and positive working relationships across multiple cultures and locations.
  • Experience leading cross-functional labeling review teams.
  • Flexible and willing to work in a dynamic and fast-paced environment while managing multiple priorities.
  • Shows strong initiative and drive. Must be an organized self-starter.
  • Proven ability to work well both within a team and independently and interact effectively across cross-functional departments; proactive and communicative
  • Ability to embrace a culture of learning and growth.

Novavax offers a base salary, annual bonus, equity grants, professional career development/growth opportunities, and a comprehensive benefits package including medical, dental, vision, Rx, STD, LTD, Life, Optional Life, 401(k) plan.

Equal Opportunity Employer/Veterans/Disabled

Novavax is an equal employment opportunity employer. Employment and advancement opportunities are available to all individuals on an at-will basis, regardless of their race, color, national origin, religion, ancestry, citizenship status, military or veteran status, sex, sexual orientation, gender identity or expression, age, marital status, family responsibilities, pregnancy, disability, genetic information, protective hairstyle, or any other characteristic protected by applicable federal, state, or local law.

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Job posted: 2022-07-10