Manager, Regulatory Affairs - CMC

Job Description

Manager, Regulatory Affairs - CMC

The incumbent is expected to be knowledgeable in project management principles, manufacturing change control management and CMC dossier structure with demonstrated ability to work with cross-functional project teams. The individual will be required to gather, review, update and report routine data and CMC related information and maintain regulatory tools and databases on a routine schedule to ensure visibility to the status of assigned activities.

As part of the Global Regulatory Affairs & Clinical Safety (GRACS) CMC Change Control & Dossier Management team, the CMC Submission Planning Scientist will be responsible for the integrated delivery of CMC submissions in alignment with program objectives by supporting the planning, preparation, and HQ release of regulatory submissions and administering associated GRACS-CMC system/process maintenance.  The CMC Submission Planning Scientist will support progression of CMC submissions from authorization, assessment, project definition, execution and implementation by managing detailed CMC timelines and content deliverables in partnership with CMC product teams.

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

Your role at our organization is integral to helping the world meet new breakthroughs that affect generations to come, and we’re counting on your skills and inventiveness to help make meaningful contributions to global medical advancement.

Primary responsibilities include, but are not limited to:

• Operates as a member of the CMC Product team to, provide project management support for development and maintenance of timelines and collection of CMC deliverables related to preparation of Chemistry, Manufacturing, and Controls information for new product registrations or post-approval changes including annual reports, registration renewals, supplements, variations, commitments, tender bids and responses.
• Lead the planning and creation of a detailed project plan in GRACS planning tool for CMC submissions with input from identified stakeholders and the CMC Product Lead. Manage project deliverables during all phases of submission preparation (e.g. authorization, assessment, execution and close-out).   Ensure project tasks are completed against plan.
• Utilizes and maintains GRACS and/or our Manufacturing Division systems to support compliant operational execution of activities related to change control and dossier preparation (GCM, RCAM, ORION, USPT, Red Compass, etc), as needed.
• Lead discussions and negotiate resolution of scheduling conflicts with our Manufacturing Division and Site/International CMC stakeholders to provide visibility to project constraints
• Support CMC scientists in collection of information to support change assessments and dossier strategy.  Liaise with our Manufacturing Division and internal stakeholders to support compliant execution of change management and CMC business processes.
• Progress and track project deliverables through appropriate business processes (Manufacturing Change Control Management, Content Authoring, Health Registration Management, and Regulatory Submission Planning). Conduct all activities with an unwavering focus on regulatory conformance.
• Identify, assess, communicate, actively resolve or escalate potential project challenges with the CMC Product Team and/or GRACS CMC management, as needed.
• Assist in the development and continuous improvement of business processes, tools, systems, metrics and analytics under supervision of manager.
• Support submission preparation and delivery under the direction of the CMC product lead and/or team members by 1) developing virtual document structures & metadata, 2) formatting, editing (e.g. grammar, spelling, punctuation), finalizing and uploading submission related documentation into GRACS systems/tools (RCAM, USPT) 3) coordinating the flow of documents via document-sharing systems (e.g., SharePoint, RCAM Workflow) to ensure version control throughout the submission generation process (writing, review, and internal approval).
• Provide support for other CMC projects and activities, as required.

Qualifications

• Master's degree, in a relevant discipline: Preferred: Degree in science, engineering
• At least 5 years’ experience in pharmaceutical industry in either pharmaceutical, biopharmaceutical or vaccine operations (e.g., manufacturing, process development, analytical, quality assurance).

Skills

• Expert-level use of Word, Excel, PowerPoint, and Adobe Acrobat and experience with document management systems (e.g., Documentum) and document sharing systems (e.g., Team Spaces/SharePoint).
• Knowledge and experience in one or more project management methodologies (e.g. PMP, Sigma, or Change etc.) and experience with associated toolsets (e.g. MS Project for project planning, MS Excel for data analysis and reporting).
• Knowledge and experience related to change control requirements, regulatory information and supporting business processes and systems.
• Capability to effectively manage and deliver against multiple and potentially competing priorities.
• Demonstrated ability to collaborate and communicate across cultures, organizational levels and disciplines.
• Capability to work effectively in matrix organizational structures.
• Demonstrated flexibility in responding to changing priorities and adapting to unexpected events by identifying innovative ways to achieve high quality, compliant deliverables.
• Exposure to regulatory affairs either through direct experience, or via a role in R&D or manufacturing
• Familiarity with CMC related CTD structure and content
• Knowledge of Trackwise and regulatory systems

We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we “follow the science” and that great medicines can make a significant impact to our world. And we believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for patients across the globe.

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:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

*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.