This Senior Specialist will be responsible for compiling and submitting regulatory submissions to Health Authorities and maintaining submission data in Regulatory Affairs systems.

Key Responsibilities:

• Responsible for publishing regulatory submissions in various formats including eCTD/NeeS, performing quality control reviews of publishing outputs, and dispatching submissions to the relevant Health Authorities including the US FDA and Health Canada.
• Responsible for preparing, dispatching and archiving 2253 submissions for OPDP.
• Communicating with RA Strategy and/or CMC Leads to ensure content accuracy and identify issues that could be incompliant with health authority guidance or impact compliance timelines.
• Ensuring final documents are submission-ready and compliant with applicable health authority requirements while addressing any advanced document or technical issues as needed.
• Archiving regulatory submissions and related correspondence in accordance with established archiving and document retention strategies and maintaining accurate records in RIM systems.
• Assisting in development and maintenance of Regulatory Operations best practices and contributing to process improvements to enhance efficiency and quality.
• Performing other responsibilities as assigned.

Qualifications:

• Bachelor’s degree preferred.
• Experienced technical skills for the preparation, publishing, and archiving of regulatory documents including tracking the status in RIM systems such as Veeva RIM.
• Knowledgeable about the FDA and Health Canada eCTD submissions lifecycle management, as well as the associated guidance, specifications, and regulations.
• Proficient in eCTD format and regulatory submission requirements.
• Working knowledge of document management systems and regulatory publishing tools, preferably with Veeva RIM and docuBridge.
• Ability to balance multiple tasks while meeting priorities and timelines.
• Experienced in leading the management of submissions and timelines and collaborating with team members.
• Demonstrate strong communication skills and the ability to work effectively within a team.
• A minimum of 3 years of combined pharmaceutical and regulatory experience is preferred.

This role is hybrid based out of Bridgewater, NJ (Tuesday, Wednesday, Thursday in office)

The range of starting base pay for this role is 98K-135K.  Actual starting pay will be based on a wide range of factors including, but not limited to, relevant skills, experience, qualifications, education and location. In addition to base pay, this position is eligible for participation in either (i) our annual bonus program or (ii) a sales incentive plan.

Benefits package includes comprehensive Medical (includes Prescription Drug), Dental, Vision, Flexible Spending Accounts, 401(k) with matching company contribution, 3-weeks paid time off plus paid sick time, stock purchase plan, tuition reimbursement, parental leave, short- and long-term disability,  life insurance, accidental death & dismemberment insurance, 12 paid holidays (including floating holidays), employee referral bonuses and employee discounts.

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