Senior Specialist, Regulatory Affairs

With limited guidance of the (Senior) Principle Scientist, Distinguished Scientist or Executive Director of Regulatory Affairs, depending upon project, the incumbent is responsible for providing procedural, administrative and planning support for new submissions and variation submissions in the EU, UK, Switzerland and the non-EU Balkan countries for products approved through the centralized and decentralized/MRP procedures.

Primary Activities:

• Provides administrative regulatory support during filing and review of new submissions, variations, in order to safeguard submissions according to EU requirements.
• Plans and coordinates new submissions, variations, CHMP referrals, FUM. to ensure timely submission.
• Drafts of module 1 components and organizing the gathering of the module 1 components.
• Collaborates closely with Regulatory Operations to establish submission timelines and content of Module 1.
• Collaborates closely with Country RA Registration Managers in order to ensure timely submission.
• For the centralized procedure, supervises and coordinates the translation process to ensure timely submission to EMA.
• Provides other administrative support related to Marketing Authorization Applications to the Executive Director, Distinguished Scientist, Senior Principal Scientist, Associate Principal Scientist or Senior Scientist as needed.
• Ensures updates to regulatory databases.
• Keeps up to date with EU procedural requirements and legislation.
• Participates as SME in relevant workstreams/projects as deemed appropriate by Regulatory Affairs Europe Senior Staff .

Qualifications, Skills & Experience

University degree (or similar such as A1 in Belgium), preferably in a science related to medicine, and at least four years of experience in the pharmaceutical industry with knowledge of the drug development and/or approval process.

• Good organizational skills, proven ability to multi-task, excellent written and verbal communication skills in English.
• Can work across boundaries, demonstrates the ability to act as intermediary across boundaries.
• Demonstrates the ability to evaluate new ideas and proposed methods for practicality and ease of implementation.
• Demonstrates ability to coordinate tasks with others for timely completion and to avoid setbacks
• Demonstrates the ability to check regulatory documents to determine accuracy and find potential errors.
• Understands the end-to-end pharmaceutical lifecycle.
• Considers the recent innovations when formulating recommendations.
• Evaluates activities and business processes across functions, identif ies areas in need for improvement and leads efforts for solution design and implementation.
• Applies and advises on policies and procedures and applicable regulations and standards.

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Employee Status:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Requisition ID:R155832