

New · posted Nov 6
Merck · Pharmaceuticals
Associate Director (Digital Engagement Partner) - Regulatory Affairs
- North Wales, PA +1 more
- Hybrid
- Full-time
- Director
The role
The Associate Director, Digital Engagement Partner is responsible for driving the adoption, engagement, governance, and business value realization of digital capabilities across the Global Regulatory Affairs and Clinical Safety (GRACS) organization. This role serves as a strategic partner to business stakeholders, helping identify opportunities, shape digital strategies, and deliver measurable business outcomes through the integration of artificial intelligence, data science, automation, Power Platform solutions, and other emerging technologies.
The position acts as the primary liaison between business functions, technology organizations, and global stakeholders to accelerate awareness, adoption, and value realization of digital capabilities. The role leads engagement strategies, stakeholder partnerships, use-case discovery, demand management, governance activities, and capability-building initiatives to ensure digital investments align with business priorities and deliver sustainable impact.
A key focus of this role is ensuring digital solutions successfully transition from innovative concepts to trusted, scalable capabilities embedded in day-to-day operations. Through stakeholder engagement, change management, communications, training, and performance monitoring, the Associate Director drives utilization, business value, and continuous improvement across a portfolio of AI, automation, and data science solutions.
What you need
Education
• Bachelor's degree in Business Administration, Information Management, Communications, Data Science, Life Sciences, or a related field, with 5+ years of experience in pharmaceutical, life sciences, or other regulated environments.
Required
• Strong balance of innovation, strategic thinking, and operational execution within regulated and GxP environments.
• Strong change leadership, negotiation, consensus-building, and stakeholder management skills.
• Experience partnering with business stakeholders, IT organizations, vendors, and sourcing partners to deliver technology-enabled solutions.
• Strong organizational awareness with the ability to influence and collaborate effectively across all levels of the organization.
• Proven success leading cross-functional, global, and matrixed teams to deliver business and technology initiatives.
• Knowledge of regulatory affairs and pharmacovigilance business processes, information, and systems.
• Excellent written, verbal, presentation, storytelling, and stakeholder-influencing skills.
Required Skills
Automation Solutions, Change Management, Cross-Cultural Awareness, Data Management, Employee Training Programs, Policy Implementation, Regulatory Operations, Stakeholder Engagement, Systems Development Lifecycle (SDLC), Vendor Management
Travel Requirements
10%
Preferrednice to have
• Strong business acumen and ability to understand complex regulatory information relationships.
• Experience with process improvement and change management methodologies (e.g., Lean Six Sigma).
• Ability to operate effectively in ambiguous environments and deliver results under aggressive timelines.
• Experience organizing enterprise innovation challenges, digital community forums, or similar innovation programs.
• Demonstrated ability to leverage Generative AI and large language models (LLMs) to solve business problems, including data preparation, model utilization, and generation of actionable outputs.
Pay and benefits
$129,000 – $203,000 a year
Employer providedAdditional location(s) Compensation Information
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
Medical, dental, vision insurance
Retirement benefits including 401(k)
Paid holidays
Vacation
Sick days
Annual bonus and long-term incentive
Where you'll work
North Wales, PA +1 moreHybridOpen in Maps (opens in a new tab)
Also posted for: Rahway, NJ
More jobs in North Wales, PA +1 moreWorking conditions
Not Indicated
Hazardous Material(s)
n/a
Employee Status
Regular
Relocation
No relocation
VISA Sponsorship
No
Flexible Work Arrangements
Hybrid
Job Posting End Date
11/13/2026
*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.
Equal opportunity, accessibility and legal noticesMerck's statements, word for word
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 characteristics. As 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:
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 another’s thinking and approach problems collectively.
Learn more about your rights, including under California, Colorado and other US State Acts
The primary location for this posting is:
USA - Pennsylvania - North Wales (Upper Gwynedd)
Where required by law, the compensation range for this role is provided below.
The salary range for the primary location of this role is:
$129,000.00 - $203,100.00
This range reflects the Company's reasonable expectation of the base salary applicable to this role at the time of posting. An employee’s 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 https://jobs.merck.com/us/en/compensation-and-benefits.
Additional location(s): Please note the salary range above applies to the Primary Location of the position. Where a role has other listed locations, different compensation guidelines may apply. You may find the salary ranges for additional locations below. If the salary range is not listed for the location you are applying to, our Talent Acquisition team will provide further information to you relevant to your location.
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.
Job intelligence
The context around this role
Live data · November 6, 2026
Salary intelligence
How the pay compares
This role's midpoint is 19% below the US median for Regulatory Operations roles at this level.
This roleEmployer provided
Director roles in the US12 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $129,000 | — | $203,000 |
| All US (middle half) | $195,750 | $204,750 | $228,000 |
This role: Merck's own published range. Comparisons: the base pay employers published on open Regulatory Operations roles at the same level on Regulatory Jobs, November 6, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Regulatory Operations
The general path across 40 open Regulatory Operations roles on Regulatory Jobs, with the titles they carry most. Not Merck's own promotion track.
Skills DNA
What this role leans on
How many of the posting's 20 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Collaboration and leadership10
- Quality systems and risk2
- GMP and compliance1
- Lab testing and methods1
- Data and digital systems1
Regulatory intelligence
The rules, regulations and standards behind this role
The regulations, guidance and standards that govern Regulatory Operations work in pharmaceuticals, each linked to the agency or standards body that publishes it.
- FDAFDA eCTD(official source, opens in a new tab)The electronic Common Technical Document format for drug and biologic submissions
- ICHICH M4 (CTD)(official source, opens in a new tab)The Common Technical Document: how a registration dossier is organized
- FDAFDA Electronic Submissions Gateway(official source, opens in a new tab)The agency-wide gateway for receiving electronic regulatory submissions
- FDAFDA Structured Product Labeling(official source, opens in a new tab)The SPL standard for submitting labeling content to FDA
- FDA21 CFR Part 11(official source, opens in a new tab)FDA rules for electronic records and electronic signatures
- FDA21 CFR Part 312(official source, opens in a new tab)Investigational New Drug applications and sponsor duties in drug trials
- FDA21 CFR Part 314(official source, opens in a new tab)Applications for FDA approval to market a new drug (NDA and ANDA)
- EUDirective 2001/83/EC(official source, opens in a new tab)The EU code for medicinal products for human use: authorization, labeling, pharmacovigilance
- EURegulation (EC) 1234/2008(official source, opens in a new tab)EU variations to the terms of a marketing authorization
- FDAFDA study data standards(official source, opens in a new tab)Required data standards and technical conformance for clinical study data
- FDA21 CFR Part 201(official source, opens in a new tab)FDA labeling requirements for drugs, including prescribing information
- EUEU Clinical Trials Regulation 536/2014(official source, opens in a new tab)How clinical trials of medicines are authorized and run in the EU, through CTIS
- Health CanadaCanada Food and Drug Regulations(official source, opens in a new tab)Health Canada's regulations for drugs, including GMP (Part C, Division 2)
- MHRAUK MHRA(official source, opens in a new tab)The UK regulator of medicines and medical devices, including UKCA marking
- PMDAJapan PMDA(official source, opens in a new tab)Japan's Pharmaceuticals and Medical Devices Agency
- FDA21 CFR 314.70(official source, opens in a new tab)Supplements and other changes to an approved application (post-approval CMC changes)
From Regulatory News
Manufacturing and quality coverage for this professionCompany hiring pulse
Merck on Regulatory Jobs
- 45
- Open roles
- 45
- Distinct roles
- 8
- Locations
By discipline
- Clinical28 62%
- Quality10 22%
- Regulatory7 16%
By level
- Director34 76%
- Associate & Specialist6 13%
- Senior & Principal4 9%
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Associate Director (Digital Engagement Partner) - Regulatory Affairs at Merck
Applications close November 13. $129K–$203K a year, employer provided.


