Associate Director, Regulatory Affairs

Job Description

Associate Director Regulatory Submissions Archive Operations

Location : Rahway NJ (Hybrid role - onsite 3 days per week required)

Functional Area : Regulatory Innovation and Information Management (RIIM) within Global Regulatory Affairs & Clinical Safety (GRACS)

The Associate Director of Regulatory Submissions Archive Operations serves as the Business System Owner (BSO) for the Veeva RIM Submissions Archive and is also responsible for managing the physical paper archives for GRACS. This dual role ensures seamless integration and governance of both digital and physical regulatory records supporting audits inspections litigation and business transactions.

Specific responsibilities of this position include :

Digital Archive Ownership (Veeva RIM Submissions Archive)

Serve as the BSO for the Veeva Vault RIM Submissions Archive overseeing system development maintenance enhancements and monitoring.

Liaise with IT Learning & Development and global stakeholders to define and implement user requirements workflows and metadata standards.

Ensure compliance with global regulatory standards and internal SOPs for electronic submissions and correspondence

Collaborate with publishing registration and planning teams to maintain alignment across the regulatory lifecycle.

Electronic and Paper Archive Management

Oversee the central archive team including offshore contractors and temporary onshore staff.

Manage archival activities related to acquisitions divestitures audits litigation and regulatory inquiries.

Ensure accuracy throughput and quality of archival work including budget oversight for temporary staffing.

Coordinate with Business Development Execution teams and system owners of related platforms (e.g. eTMF) for migration and record alignment.

Strategic Leadership

Support GRACS long-term strategy to unify regulatory platforms under Veeva RIM ensuring cross-functional coordination and system interoperability.

Represent the archive function in strategic planning meetings system integration workshops and change management initiatives.

Advocate for continuous improvement in archival processes leveraging analytics and stakeholder feedback.

Required :

Bachelors degree in a business scientific or operational discipline relevant to the life sciences and / or operations areas or a minimum of 12 years of industry experience at least 6 of those in a regulatory / compliance industry utilizing records / document management systems.

Direct experience in Veeva RIM Submissions Archive.

Proven leadership in managing both digital systems and physical archives.

Strong understanding of regulatory submission types (eCTD IND NDA ANDA) and Health Authority requirements.

Knowledge of system development lifecycle data / content administration concepts and capabilities applying technology within a business environment.

Experience supporting and working with tools and systems used in a regulatory / compliance environment including managing archival collection or distribution for acquisitions divestitures litigations audits regulatory inquiries and ad hoc work.

Deep knowledge of managing records related to submissions content health authority correspondences and other regulatory documents.

Demonstrated capabilities managing and mentoring staff including managing onshore and offshore vendors for records management and related activities.

Proven leadership in Change Management with an ability to lead and influence others outside of a direct reporting relationship.

Demonstrated collaborative skills and ability to work in cross-functional and international environments.

Excellent communication stakeholder engagement and project management skills.

Preferred :

Experience with other modules in Veeva RIM such as Registrations Submissions and Publishing.

Advanced knowledge and capabilities applying technology within a business environment

Sigma Black Belt Change Management Certification PMI Certification.

Required Skills :

Biological Sciences Business Strategies Business Systems Change Management Data Management Divestitures Document Management Employee Training Programs FDA Regulations Life Science Pharmaceutical Regulatory Affairs Pharmacovigilance Policy Implementation Regulatory Affairs Compliance Regulatory Affairs Management Regulatory Compliance Regulatory Documents Regulatory Labeling Regulatory Operations Regulatory Submissions Stakeholder Engagement Strategic Thinking Systems Development Lifecycle (SDLC) Veeva Vault Vendor Management

Preferred Skills :

Current Employees apply HERE

Current Contingent Workers apply HERE

US and Puerto Rico Residents Only :

Our company is committed to inclusion ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.

As an Equal Employment Opportunity Employer we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race color age religion sex sexual orientation gender identity national origin protected veteran status disability status or other applicable legally protected a federal contractor we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws visit :

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We are proud to be a company that embraces the value of bringing together talented and committed people with diverse experiences perspectives skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas broad experiences backgrounds and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one anothers thinking and approach problems collectively.

Learn more about your rights including under California Colorado and other US State Acts

U.S. Hybrid Work Model

Effective September 5 2023 employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week Monday - Thursday although the specific days may vary by site or organization with Friday designated as a remote-working day unless business critical tasks require an on-site Hybrid work model does not apply to and daily in-person attendance is required for field-based positions; facility-based manufacturing-based or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note this Hybrid work model guidance also does not apply to roles that have been designated as remote.

The salary range for this role is

$126500.00 - $199100.00

This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employees position within the salary range will be based on several factors including but not limited to relevant education qualifications certifications experience skills geographic location government requirements and business or organizational needs.

The successful candidate will be eligible for annual bonus and long-term incentive if applicable.

We offer a comprehensive package of benefits. Available benefits include medical dental vision healthcare and other insurance benefits (for employee and family) retirement benefits including 401(k) paid holidays vacation and compassionate and sick days. More information about benefits is available at can apply for this role through (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.

San Francisco Residents Only : We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance

Los Angeles Residents Only : We will consider for employment all qualified applicants including those with criminal histories in a manner consistent with the requirements of applicable state and local laws including the City of Los Angeles Fair Chance Initiative for Hiring Ordinance

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 : Not Indicated

Valid Driving License :

No

Hazardous Material(s) :

n / a

Job Posting End Date :

12 / 13 / 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.

Required Experience :

Director

Key Skills

Proofreading,Adobe Acrobat,FDA Regulations,Manufacturing & Controls,Biotechnology,Clinical Trials,Research & Development,GLP,cGMP,Product Development,Chemistry,Writing Skills

Employment Type : Full-Time

Experience : years

Vacancy : 1

Monthly Salary Salary : 126500 - 199100