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Associate Director, Regulatory Operations job in Lower Gwynedd Township at Organon

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Associate Director, Regulatory Operations at Organon

Associate Director, Regulatory Operations

Organon Lower Gwynedd Township, PA Full Time

This role will provide support across Regulatory Operations activities in the Latin America region spanning the submission planning and publishing work. The role will be accountable for the delivery of timely and high-quality regulatory dossiers from planning through to delivery at Country RA or submission to the authorities and serve as the primary contact for submission activities within the region.

It will be important for this role to be a conduit of information between the broader Global Reg Ops Regional Teams (EU/EEMEA, APAC, Americas) to the Regional (Product Registration) Regulatory Teams. There is also an expectation to coordinate with other Strategic Operations leads (e.g. PV Ops, Label Ops, Information Management, Business Development & Vendor Management, Portfolio Planning and Execution) and Manufacturing/CMC.

A key focus will be providing leadership, support and subject matter expertise (SME) to partner planners and publishers.

Organizational Relationships

  • This position will report to the Director of Regulatory Operations within Regulatory Operations within Strategic Operations in the Research and Development.

  • This is an individual contributor role.

Primary Responsibilities may span both Submission Publishing and Planning Capabilities:

  • PLANNING SPECIFIC:

  • Actively manages submission timelines and has a clear understanding of dependencies and critical path activities

  • For assigned products, works closely with the Regulatory Lead to assess the overall program and manages the sequencing of submissions as needed

  • Facilitate meetings effectively and clearly communicate decisions and action items to team members and relevant stakeholders

  • Assemble a cross-functional team and drive identification, planning, and execution of regulatory and safety submissions, with an end-to-end mindset

  • PUBLISHING SPECIFIC:

  • Lead the production of high quality submission assemblies utilizing submission-ready documents that adhere to internal and external electronic submission guidelines

  • Ensure submission assemblies meet the level of technical integrity required for our Company and health authority validation tools

  • Assist submission project teams with the identification of submission ready content requirements and applicable timeline milestones for execution of right-first-time submission assemblies

  • GENERAL:

  • Independently identify, assess and actively resolve or escalate where necessary any risks or issues that could impact the successful completion of regulatory submissions

  • Proactively and creatively problem-solves, makes effective and timely decisions while skillfully negotiating to resolve conflicts

  • Ensures project data, including information used to maintain compliance and aid with submission planning, is accurately reported in databases

  • Assume the lead role in the development of processes and documentation, including user acceptance testing for new and updated tools. Delegation of these project activities to planners/publishers within the department as needed.

  • Assume the role of subject matter expert for specific functions or processes, interacting and mentoring both within the department and with external stakeholders

  • Assume the lead for training/mentoring internal and external staff

  • Assist with departmental metrics by tracking status of projects, day-to-day production activities, and anomalies.

  • Continuously develops and improves leadership and project management skillsets, understanding of drug/vaccine/biologics/device development, and regulatory practices

Education:

  • Required: Bachelor’s degree plus 5 years of regulatory operations experience

  • Preferred: Bachelor’s degree plus 8 years of regulatory operations experience

  • Proven bilingual proficiency in both English and Spanish

Skills & Experience

  • In depth working knowledge of industry standard publishing systems and desktop applications including MS Word and Adobe Acrobat Professional

  • Detail-oriented with the ability to understand the “big picture” and overall strategy of projects/programs

Preferred Experience:

  • Experience with the Liquent InSight Publisher application

  • Experience with industry standard electronic document management system

  • Experience with project management and leading teams

  • Must have proven track record to be able to think critically, strategically, independently and problem solve

  • Must have high level of motivation, drive, and demonstration of Organon leadership values

  • Excellent written and verbal communication skills including ability to write clearly and concisely

  • Top notch interpersonal skills in difficult situations

  • Driver of change and innovation

  • Ability to work seamlessly with all levels of personnel

  • Demonstrated sensitivity and knowledge of cultural differences with experience in multi-country, multi-cultural environments and demonstrated success with cross-geographically based cultural collaborations

  • Excellent word processing, SharePoint, Excel, e-mail, and online meeting tool skills

  • Ensure global regulatory compliance (FDA, MDD, CMDR)
  • Address regulatory compliance and other regulatory policy issues
  • Lead worldwide regulatory affairs and develop regulatory strategy, implement strategy and manage efforts of regulatory staff
  • Ensure a global regulatory strategy
  • Identify and implement process improvements for regulatory affairs
  • Build a regulatory affairs department to support current and future clients in regulatory oversight and support regulatory filings
  • Manage timelines for regulatory submissions
  • Assist Denmark, German regulatory affairs
  • Develop and oversee the strategic plan for regulatory affairs
  • Establish national regulatory affairs and market development strategy and plan
  • Develop global regulatory strategies and update based upon regulatory changes
  • Provide strategic state government affairs guidance
  • Direct and prepare regulatory submissions
  • Facilitate meetings with regulatory agencies
  • Support regulatory product submissions or registrations
  • Provide support for international registrations and support to global regulatory affairs teams
  • Facilitating compliance with all regulatory requirements, including interface with regulatory agencies
  • Manage all regulatory projects, developing and executing regulatory plans
  • Direct the reimbursement and regulatory affairs of client facilities
  • Manage the regulatory group that perform regulatory and quality compliance functions

Recommended Skills

Bilingual English/Spanish
Regulatory Operations

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