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Associate Director, Regulatory Operations
hace 3 meses
This role will provide support across Regulatory Operations activities in the Latin American (LATAM) 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 Regulatory Affairs (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 Regional Operations 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/Chemistry, Manufacturing and Control (CMC).
This position will report to the Director of Regulatory Operations LATAM within Regulatory Operations within Strategic Operations in the Research and Development organization of our Company.
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 crossfunctional team and drive identification, planning, and execution of regulatory and safety submissions, with an endtoend mindset.
Publishing Specific:
- Lead the production of highquality submission assemblies utilizing submissionready documents that adhere to internal and external electronic submission guidelines.
- Ensure submission assemblies meet the level of technical integrity required for Merck and health authority validation tools.
- Assist submission project teams with the identification of submissionready content requirements and applicable timeline milestones for the execution of rightfirsttime 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 problemsolves and 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 lead for training/mentoring internal and external staff.
- Assist with departmental metrics by tracking the status of projects, daytoday production activities, and anomalies.
- Continuously develops and improves leadership and project management skillsets, understanding of drug/vaccine/biologics/device development, and regulatory practices.
Education Minimum Requirements:
- Required: Bachelor's degree plus 5 years of regulatory operations experience.
- Preferred: Bachelor's degree plus 8 years of regulatory operations experience.
Required Experience and Skills:
- Detailoriented with the ability to understand the "big picture" and overall strategy of projects/programs.
- Advanced English and Spanish,
fully bilingual.
Preferred Experience and Skills:
- Experience within industrystandard 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.
- Topnotch interpersonal skills in difficult situations.
- Driver of change and innovation.
- Ability to work seamlessly with all levels of personnel.
- Portuguese Language Skills.
Who We Are:
Organon delivers ingenious health solutions that enable people to live their best lives.
We are a $6.5 billion global healthcare company focused on making a world of difference for women, their families and the communities they care for.
We have an important portfolio and are growing it by investing in the unmet needs of Women's Health, expanding access to leading biosimilars and touching lives with a diverse and trusted portfolio of health solutions.
Our Vision is clear:
A better and healthier every day for every woman.
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