Regulatory Affairs Associate

Responsibilities

• The Associate, Regulatory Affairs Submission Management, manages low to medium impact submission projects involving multiple cross-functional regulatory submission teams.
• With input from the submission teams, this individual establishes and maintains submission content planners and associated timelines, facilitates tactical submission team meetings, prepares content planners for publishing, interfaces with publishing vendor, and fulfills Submission Management functions on Project Teams in support of Development, Marketing, and post-marketing regulatory authority applications.
• This individual is recognized as a very knowledgeable in their discipline expert and in regulatory affairs submission management.
• Manages low to medium impact (with respect to internal visibility, risk, complexity and criticality) submission projects to ensure the timely delivery of high-quality dossiers that meet technical specifications defined by regulatory authorities and can be easily navigated and reviewed by a regulatory agency.
• Acts as RA Submissions support to project teams providing guidance and communication of established submission processes and standards.
• Provides input to project publishing timelines and deliverables.
• Participates in submission team meetings.
• Expedites, manages, and coordinates multiple concurrent interrelated activities for submission projects in the delivery of low to moderately complex published submissions within the required timelines.
• Anticipates obstacles and proposes solutions within the team.
• Coordinates submission publishing with offsite publishers/provides notification to ensure all required resources are available to meet submission timelines.
• Prepares content planner for publishing and works with vendor to resolve publishing issues.
• May perform in-house publishing tasks
• Facilitates the creation or procurement of submission content deliverables such as cover letters and forms
• Performs detailed quality reviews of published output to ensure compliance with Regulatory Standards and Health Authority guidance's including verification of content, bookmarks, hypertext links and tables of content in low to moderately complex submissions. Facilitates team reviews.
• Contributes to the development of optimal business processes and standards within the department to ensure high levels of customer support and to achieve high quality submissions.
• Contributes to the implementation of internal process and standards documents relating to publishing and publishing deliverables.
• Suggests and contributes to process improvements, including changes to software and business processes.
• May participate on internal project teams to update business software.
• Demonstrates ability to influence without direct authority.
• Builds and maintains positive relationships internally and externally.
• Receives project assignments from manager but has responsibility for managing own projects with oversight.
• Reviews project progress with manager on a regular basis with direction provided by manager.
• May assist with onboarding staff.
  
  

Qualifications

• Required Education: Bachelor's Degree
• Required Experience: Two years pharmaceutical or industry related experience
• Preferred experience: Publishing related software tools e.g. Documentum, eCTDXPress/ISIPublisher, ISI Toolbox/DocuBridge/Insight platform, Adobe Acrobat.
  
  

Benefits

Healthcare Insurance: Synectics offers eligible employees and their dependents healthcare coverage through BlueCross BlueShield of Illinois. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics. Premiums are subsidized by Synectics.

Dental Insurance: Synectics offers eligible employees and their dependents a dental plan through MetLife. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics.

Vision Insurance: Synectics offers eligible employees vision insurance through VSP. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics.401(k) Plan: The Synectics Inc. Investment Savings Retirement Plan. Synectics offers all employees who are 21 years of age or older the opportunity to invest in the 401(k) Plan on the first enrollment date that is at least 30 days after employment begins. Enrollment dates are each January 1st, April 1st, July 1st, and October 1st.

Technical Certification Bonus: Synectics is pleased to award its employees a bonus of up to $500 for an approved professional certification. In determining the bonus amount, Synectics will consider the cost of the test(s) for any certification relating to your current position, achieved during your employment with us. Only one Certification Bonus per calendar year may be awarded per employee. Only current, active employees will be eligible to receive this bonus. It will be awarded 90 days after the Synectics office has received documentation confirming the successful completion of the certification.

Synectics is an equal opportunity employer.