Manager/Senior Manager, Regulatory Affairs: Labeling

10 Jul, 2022

Jobs

Manager/Senior Manager, 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 a Manager/Senior Manager position with experience executing daily operations for a global labeling group within the Regulatory Affairs organization. This position will report to the Associate Director, Regulatory Affairs: Labeling. The Manager/Senior Manager for Regulatory Affairs Global Labeling will function as the regulatory expert for labeling on the Global Regulatory Affairs (GRA) and other teams to ensure that regulatory labeling requirements are met for product submissions and potential future development. This position will report to the Associate Director of Global Regulatory Affairs (GRA) Labelling involve close collaboration with the Global Regulatory Affairs team and cross-functional project teams for all aspects of labeling management in support of the global development of Novavax’ products through licensure and beyond.

Location: Fully Remote/ Hybrid

Major tasks and responsibilities include but are not limited to:

The Manager/Senior Manager of Labeling has the following responsibilities:

  • Support of local Regulatory Affairs (RA) Regional Lead and RA Labeling with all regulatory labeling activities for registered products and potentially other markets throughout the product lifecycle
  • Participate in the development and execution of global labeling strategies in collaboration with RA Regional Lead and RA Labeling.
  • Liaise with Global Project Management (GPM) to ensure that project timelines for assigned regions support the coordination and preparation of timely regulatory submissions.
  • Coordinates with submission team to identify and provide all labeling related Module 1 documents to be included within submission content plans.
  • Recommend concise labeling language for inclusion in product labels consistent with information in the CCDS and source files; obtain input and approval from all relevant functional areas with appropriate annotation and supporting documentation.
  • Prepare and provide of content with relevant supporting materials for labeling governance reviews; ensures outcome from reviews is reflected in final labeling prior to submission to local HA.
  • Ensure regulatory labeling documents are in accordance with local Health Authority (HA) requirements and content reviews and QC checks are performed for all labeling, including artwork.
  • Leading the regulatory evaluation of change control requests and participates in discussions for change controls related labeling impact for assigned regions, provide regulatory input for planned and ongoing changes, support risk assessment of the change controls.
  • Act as regulatory representative on internal workstreams/project teams.
  • Author or contribute to and manage key supporting documents for labeling updates (e.g., summary of changes documents, justification documents, HA response documents)
  • Analyze relevant competitor labeling to ensure the most competitive labeling possible; maintain awareness of recent therapeutic area or class approvals.
  • Contribute to the development and review of processes and procedures to ensure continuous improvement of the global labeling program and compliance.
  • Participate in training regulatory and labeling review teams on relevant labeling policies and procedures, as needed

Minimum requirements:

  • Bachelor’s degree preferably in a scientific field. An advanced degree is desirable.
  • A minimum of 6 years in the drug development industry with 4 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:

  • Possesses and understanding of the drug development process and global regulatory environment
  • 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.
  • Strong communication skills (oral, written, and interpersonal); critical-thinking and ability to identify and recommend solutions to problems.
  • Attention to detail and proofreading skills
  • Familiarity with eCTD file structure and referencing data within eCTD Modules highly desired.
  • Experience using an electronic document and artwork management systems is highly desired.
  • 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