(Contractor) Regulatory Affairs Specialist

The (Contractor) Regulatory Affairs Specialist responsibilities encompass the support of international drug product applications. Support of regulatory activities including but not limited to:

• Plan/author/compile drug product dossiers in CTD format for expansion to international markets
• Plan/author/compile/submit/manage variations for marketed products outside the United States
• Respond to health authority information requests and comments to achieve approval
• Review and assess CMC regulatory impact and provide regulatory strategy for post-approval changes proposed at the manufacturing site
• Participate in cross-functional teams and provide health authority requirements needed for support of initial international filings and post-approval changes
• Facilitate the creation of foreign language labeling content to meet local health authority requirements
• Maintain regulatory knowledge of current guidelines and regulations
• Maintain current regulatory databases and produce various reports as needed
• Provides mentorship for entry-level regulatory associates
  
  

• Authoring, organization, and preparation of CTD regulatory filings; also includes peer review of filings
• Understand, identify potential regulatory risks and recommend strategies based on current ICH and health authority requirements
• Manage multiple priorities
• Attend necessary trainings and seminars to keep abreast of new and/or changes in the Regulatory profession.
• Process, interpret, and provide recommendations for complex, unusual issues.
• Critically review documentation for regulatory submissions and provide input for necessary revisions.

• Bachelor Degree in scientific discipline required or equivalent work experience.
• 3 or more years ofRegulatory experience or related field required.
• Self-starter who takes initiative to learn, grow and excel as a Regulatory Affairs professional.
• Background in manufacturing, research and development, or quality assurance sufficient to understand how products are produced and marketed.
• Strong organizational skills, strong attention to detail, ability to problem solve and to work well with others and cross-functionally.
• Cross-functional interaction experience, coordinating activities, driving assigned submissions to completion, and working to align communications with other departments is required.
• Excellent written and oral communication skills.
• Use of software system to manage change controls.
• Strong background using Microsoft Office tools and Adobe Acrobat.
• Travel Time Required - up to 10% (May vary depending on region/site)

Working Conditions:

• Standard office environment
• Willingness to work in a team-based environment.
• Close attention to detail required.
• May be required to sit or stand for long periods of time while performing duties.
• Must be able to work outside of regular work hours.
• Responsibilities also include the ability to lift, walk, bend, stoop, push, pull, reach, and climb stairs with or without accommodation.
• Must possess good hand-eye coordination.

Curium offers a comprehensive and competitive Total Rewards Package built on a pay-for-performance philosophy and designed to promote employee growth and success. The annual base salary for this role is $65,000 - $68,000. The base pay range reflects the target for new hire salaries where individual pay is determined by work location and additional factors, including job related skills, experience and relevant education or training. This is the range that we in good faith anticipate relying on when setting wages for this position. We may ultimately pay more or less than the posted range, which may also be modified in the future. Your HR contact can share more details about the base salary range during the hiring process.