Senior Specialist Regulatory Affairs

Job Description

The Shared Services Delivery Model (SSDM) Senior Specialist role reports to the SSDM Associate Director and will partner cross functionally within Global Regulatory Affairs and Clinical Safety and cross divisionally where applicable to ensure the regulatory post-approval operations in scope of SSDM (Renewals, Deletions, Mergers, Acquisitions, Transfers, Legal Entities changes, Site name changes, Tender Bids and artwork implementation) are planned, managed, and executed timely and accurately, issues are identified and resolved, and opportunities for improvement of the business processes are pursued.

Specific responsibilities include:

• Act as the process steward by monitoring that the established procedures, roles and responsibilities and the data entries are being followed; serve as a point of contact for any process related queries, escalate any major issues to the business process owner;
• Prepares the metrics for the designated business process;
• Facilitates necessary process documentation updates and periodic revisions;
• Supports training, education, knowledge sharing and communication activities for the process;
• Contributes to improvement or re-engineering/simplification of the business process and related tools;
• Supports Regulatory Oversight Lead with the regulatory impact assessment, overall planning, validation of change scope and regulatory intelligence;
• Partners very closely with Country Regulatory Affairs and the Outsourcing Partner (for some processes) during the planning and execution of the business process or a project to collect necessary inputs for the accurate planning, confirms country unique requirements;
• Participates in the country or sub-regional meetings to drive necessary strategy alignment among the stakeholders, involved in the change management by driving the alignment between country and regional or global stakeholders;
• Represents Regulatory in cross functional/divisional projects for planning and implementation of Marketing Authorizations Transfers (MATs), legal entity changes, site name changes, mergers & acquisitions, and advice/facilitates product transition plans execution jointly with country Regulatory Affairs;
• Identifies and reports regulatory risks;
• Drives and oversees regional scheduling and planning activities, ensures high level accuracy;
• Secure continuous follow-up & interaction with Regulatory Affairs International stakeholders on execution status and on tracking milestones’ achievements of the project plans;
• Reports monthly and quarterly project updates by using the designated communication dashboards;
• Prepares high quality labeling, artwork packages, and conducts assessments of captioning and artwork management.

These activities are aimed at supporting the timely submission of new Marketing Authorization Applications, variations, and supplementary marketing authorizations. These tasks are associated with labeling and artworks activities. Partnering with local Clinical Research Associates to be able to submit to local authorities, maintains local files, updates tracking systems, databases, and handles minor translations.

Required Qualifications/Experience:

• Bachelor’s degree in life science, engineering, business or a related field;
• Excellent verbal and written communication skills in English;
• Previous experience within the Pharmaceutical Industry;
• Previous experience in Regulatory Affairs, Chemistry, Manufacturing and Control (CMC), compliance management or Quality, working with external partners and/or dealing directly with regulatory agencies is preferred;
• Good organizational skills with a proven ability to simultaneously balance diverse activities for multiple projects;
• Strong interpersonal/communication skills and capacity to work across the geographies with the high number of stakeholders;
• To be familiar with local and regional legislation frameworks, procedures and guidelines governing pharmaceutical products;
• Understanding of Operational Excellence principles;
• Ability to work through the matrix approach in a culturally diverse environment and communicate effectively, both verbally and written, with others across all levels of the organization;
• Innovative mindset and design thinking skills are preferred.

We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.

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Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, 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:

No Travel Required

Flexible Work Arrangements:

Hybrid

Shift:

1st - Day

Valid Driving License:

No

Hazardous Material(s):

n/a

Requisition ID: R271160