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Regulatory Affairs Senior Manager

  • Location: New Jersey, 99999
  • Job Type:Contract

Posted 2 months ago

Our client is a global professional services firm that drives digital-led innovation and digitally-enabled intelligent operations for customers. Join their team today to help transform Fortune 500 companies around the world.

Position: Technical Project Manager

Location: Virtual, New Jersey 99999

Term: 11 Months

Experience - 7-12 Years

Responsibilities

  • The Regulatory Affairs (RA) Senior Manager is responsible for maintaining or obtaining Health Authority (HA) approval for our client’s pharmaceutical portfolio.
  • They will guide regulatory strategy in line with regional, national and international requirements and establish dossier timelines from authoring through to submission and approval at the HA.
  • They will be responsible for end-to-end management of regulatory submissions including Planning, module 1, 2 & 3 authoring/review/publishing & dispatch.
  • In parallel, the person assumes responsibility to assure dossier status through timely and accurate maintenance of dossier information in regulatory planning and document management systems.
  • Works with colleagues from multiple regions in order to deliver a dossier that meets the technical requirement (such as but not limited to eCTD, NeES and Paper) and regional/local regulatory requirements for which the submission is targeted (Asia Pacific, Australia/New Zealand, Africa - Middle East, Europe, East Europe, Latin America and the United States)
  • Proactively enters and maintains critical regulatory information relating to assigned submissions within required systems and to required standards and timelines.
  • Through active management of status and expected deliverables, identifies risks and formulates a strategy to mitigate those risks to quality and timeliness of submissions
  • Delivers electronic and paper regulatory submissions through coordination and execution to requirements and standards of each submission and national markets.
  • Maintains a working knowledge of electronic and paper publishing systems and tools and how these are applied; fluency with multiple dossier formats and translation requirements as required.
  • Assists with the interpretation of regulatory technical guidelines in order to produce business requirements and ensure that those requirements are implemented where appropriate at a local level.
  • Adheres to the required use of technical tools, through the use of working practices and QC/QA regimes, such that regulatory and internal compliance is preserved.
  • Manages and leads a team of Reg Affairs professionals to deliver quality, first-time right, regulatory content.
  • Project manages a team to ensure deliverables and service levels are met and within the agreed timelines.
  • Works with the client to develop a clear and detailed plan for reporting metrics.
  • Acts as the liaison/single point of contact to the client for all process-related items and participates in client governance meetings on a regular basis.

Qualifications

  • Bachelor's degree required in science, engineering or related field (advanced degree preferred).
  • Experience in global regulatory affairs and regulatory operations. Proven success in compiling and filing regulatory submissions and Marketing Authorizations end to end.
  • Proven and relevant regulatory affairs experience in a pharmaceutical, vaccine, or biological products; or related fields.
  • Proven experience in managing a regulatory team successfully, including duties such as providing regulatory strategy and guidance, reporting, tracking SLAs, training and managing client/pharma company expectations.
  • Demonstrated superior oral and written communication skills in multicultural settings and the ability to communicate complex issues in a succinct and logical manner. Strong listening skills.
  • Demonstrated ability to generate innovative solutions to complex regulatory problems and effectively work with and communicate with key stakeholders.
  • Demonstrated flexibility in responding to changing priorities or dealing with unexpected events.
  • Demonstrated effective leadership, communication, interpersonal and negotiating skills.
  • Ability to prioritize tasks to meet deadlines and collaborate with a team when help is needed.
  • Skilled at fostering customer relationships and driving collaboration.

Candidates will be responsible for following the client's COVID-19 protocols. Please refer to your MATRIX representative for specifics.

About Us

At MATRIX, we expertly match talented professionals with job opportunities to elevate careers. Since 1983, we have placed thousands of professionals at innovative clients across every industry ranging from small startups to Fortune 50 companies. It’s why we’re consistently in the top 25 of all U.S. IT staffing firms and why our consultants rate us well above the industry average, earning us ClearlyRated's Best of Staffing awards year after year. People come to us for a job, and stay with us because of our top-notch consultant care.

MATRIX is and Equal Employment Opportunity employer including disability and veteran and provides reasonable accommodations for all qualified individuals.  Supporting medical or religious documentation will be required where applicable. If you are a qualified individual you may request a reasonable accommodation under the American Disability Act (ADA). If you are a person with a disability needing assistance applying, or at any point in the hiring process, please email us at MATRIX_HR@MatrixRes.com. To ensure a quick response to your request, please use the words “Accommodation request” as the subject line of your email.