Sr Specialist Product Change Management

Job Description

Role Description 

The Senior Specialist - Product Change Management & Implementation will support the Lead of the department in ensuring compliance with regulatory requirements and executing strategies for managing international (ex-US) post-approval changes within the pharmaceutical supply chain.

The senior specialist will collaborate with various departments, including Human Health, Supply Planning, Demand Management, SC Fulfillment, Market Planning, internal/external manufacturing sites, Regulatory Affairs, Global Artwork, Serialization, Master Data, Finance, Global Logistics, and Quality. This role requires a strong understanding of regulatory frameworks, attention to detail, and the ability to work collaboratively with cross-functional teams.

Responsibilities Primary activities include, but are not limited to:

• Leading cross functional projects, managing complex information flow, coordinating, and integrating the functional/ tactical project management activities for Network Changes and Regulatory driven changes with Artwork impact, in close collaboration with Value Chain Management, Product Source management and partner with Planners, other Supply Chain functions, and stakeholders across divisions.

• Lead and coordinate activities to mitigate risks related to the different milestones across the SKU change management and implementation stages including, but not limited to: Code Creation, Initial RCT update, Forecast Positioning, Artwork Readiness, First Packaging/ Pack-by Readiness, in line with the Regulatory Implementation Definition, last packaging to guarantee successful post approval change by ensuring system readiness to allow execution.

• Responsible for and providing end to end visibility for all projects within assigned product portfolio to all stakeholders throughout all divisions.

• Coordinate activities to mitigate risks related to Artwork Readiness. Liaise with Regulatory Affairs, Artwork Centers, and Quality for timely execution.

• Drive process improvement initiatives when needed.

• Implement, track and report KPls mitigating risks to minimize impact to business; participate and provide input to the IBP process (Demand Reviews, Site Supply Reviews).

• Understand & translate the packaging lead times, capacity issues, process reliability issues, sourcing flows, market specific requirements (e.g., TOI, shelf-life requirements, etc.) and regulatory issues impacting supply into appropriate risk mitigation actions.

Change Management Execution:

• Assist in the development and implementation of strategies for managing post-approval regulatory changes in the supply chain.

• Collaborate with cross-functional teams to assess the impact of regulatory changes on the supply chain.

• Support the execution of change control processes and procedures to ensure compliance with regulatory requirements.

• Contribute to the implementation of post-approval change initiatives, including risk assessment and mitigation strategies.

Network & Source Changes:

• Ensure early engagement with Product Source Management group for robust implementation of Source of supply Changes by translating existing source change project into tangible supply chain system readiness milestones while minimizing impact on service and cost

• Identify scope of change and analyze impact on resource planning

• Assessing and influencing target dates from an end-to-end perspective.

Regulatory Driven Artwork Changes:

• Responsible for the coordination and tracking of Artwork Milestones

• Tracking and reporting upon the initiatives and projects in the overall portfolio using information available in Regulatory tools

• Work with project lead to use process toolset to construct, deploy and maintain the methodology which is used to manage large scale initiatives/projects including Serialization, Corporate initiatives, Divestitures.

• Execute Phase in/ Phase out of SKUs related with material proliferations required due to Regulatory requirements/ Serialization/ Harmonization

• Manage the Last Authorized Shipping Date Process for the assigned product portfolio

Regulatory Compliance Support:

• Monitor global regulatory requirements related to post-approval changes in the pharmaceutical industry.

• Analyze and interpret regulatory guidelines to assess their impact on the supply chain.

• Provide support and recommendations to internal stakeholders regarding compliance matters.

Project Support:

• Manage projects related to regulatory change management and implementation.

• Support resource coordination, timeline tracking, and deliverable completion.

• Identify and report project risks and propose solutions.

Data Analysis:

• Collect, analyze, and summarize data to support decision-making and project evaluation.

• Prepare reports and presentations on SKU change status, milestones, and key findings.

Cross-Functional Collaboration:

• Collaborate with regulatory affairs, quality assurance, manufacturing, logistics, and other relevant departments to support the implementation of regulatory changes.

• Support the assessment and resolution of post-approval changes' impact on product quality, supply, and distribution.

• Foster collaboration and communication across cross-functional teams.

Documentation and Reporting:

• Maintain accurate and up-to-date records of post-approval regulatory changes in the supply chain.

• Prepare reports and documentation for regulatory agencies, internal audits, and senior management.

• Ensure proper documentation and archiving of regulatory filings, correspondence, and other relevant documents.

Professional Education and Skills

• Bachelor's degree in biopharmaceutical supply chain, regulatory affairs, or a related field.

• 3 to 5 years of relevant experience in regulatory affairs, supply chain management, or a related field within the pharmaceutical industry.

• Strong knowledge of global regulatory frameworks and guidelines related to post-approval changes in the pharmaceutical supply chain.

• Attention to detail and ability to analyze and interpret regulatory guidelines.

• Good communication and interpersonal skills to collaborate with cross-functional teams.

• Ability to work both independently and as part of a team.

• Familiarity with regulatory information management systems and document control processes.

• Proficient in the use of business software (including MS Excel, MS PowerPoint, MS PowerBI, MS Apps)

THE COMPANY

Our company has had a presence in Switzerland since 1963. With a regional office and manufacturing/packaging facility, Lucerne is considered the center of operations. Approximately 1,000 people work collaboratively at the four Lucerne locations (Tribschenstrasse, Citybay, Schachen and Kriens). A fifth location has been established in Zurich, aimed at accelerating the development and commercialization of many of our company's medicines and vaccines, which supports our mission to save and improve lives around the world.

We are proud to be certified as a "Top Employer Switzerland" and "Top Employer Europe" showing the company's commitment to our employees and the community around us.

Required Skills:

Adaptability, Adaptability, Analytical Thinking, APICS CPIM, Biopharmaceutical Industry, Budgeting, Change Control Management, Change Control Processes, Data Analysis, Demand Forecasting, Detail-Oriented, Inventory Management, Logistics Management, Manufacturing Compliance, Microsoft PowerPoint, Mitigated Risks, Order Management, Personal Initiative, Process Improvement Projects, Process Improvements, Production Scheduling, Regulatory Affairs Compliance, Regulatory Change Management, Regulatory Compliance, Regulatory Frameworks {+ 4 more}

Preferred Skills:

Current Employees apply HERE

Current Contingent Workers apply HERE

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:

Not Applicable

Shift:

Not Indicated

Valid Driving License:

No

Hazardous Material(s):

N/A

Job Posting End Date:

12/4/2025

*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Requisition ID:R374255

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