Job Detail

JOB DESCRIPTION

Job Description

Our Regulatory Affairs team bring new medical advancements to the world by facilitating communications and procedures that allow swift, organized compliance partnering with external regulatory agencies. We are on the leading-edge of healthcare breakthroughs that help provide new, reliable, and compliant medical products, practices and solutions to the world.

We are looking for an Associate Director Regulatory Operations EU/EMEA.

This role will provide support across Regulatory Operations activities in the EMEA 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. 

Primary Responsibilities:

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


• 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 

Qualification, Skills & Experience 

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


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


• 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 

#NewCo

Search Firm Representatives Please Read Carefully 
Merck & Co., Inc., Kenilworth, NJ, USA, also known as Merck Sharp & Dohme Corp., Kenilworth, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.  No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. 

Employee Status:

Regular

Relocation:

No relocation

VISA Sponsorship:

No

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Number of Openings:

1

Requisition ID:R71200