Associate Director, Regulatory Affairs

Job Description

Associate Director, Portfolio & Program Management (PPM)

The Associate Director in Regulatory Planning and Publishing works closely with various stakeholders to drive the identification, planning, execution, and management of activities that deliver high quality and timely regulatory and safety submissions for approval. The incumbent will be responsible for translation of regulatory strategy into an execution plan and is expected to have excellent project management skills with a strong track record of demonstrated leadership on cross-functional regulatory teams. Should be capable of independent management of all submission projects and documents, at any level of complexity, across all submission types throughout the product lifecycle. Additionally, the incumbent will be involved in leading or supporting internal or external process improvement or strategic initiatives.

The responsibilities may include the following:

• Manage and develop a team of direct reports with a keen commitment to providing value.
• Expectations are that the incumbent will also coach their staff in the concepts, methods, and nuances of, drug development, project management, and regulatory operations.
• Operates well in the face of ambiguity and can translate complexity to their staff.
• The incumbent is involved in leading or supporting within or across departmental business processes , tools, and system improvements.
• Ensure project data, including information used to maintain compliance and aid with submission planning is accurately reported in databases.

Qualifications, Skills & Experience

Education Minimum Requirement - Bachelor's Degree

• Minimum of 4 years of experience in pharmaceutical/healthcare/consumer care industry
• Leading cross-functional teams in regulatory affairs or other drug development functions
• Working knowledge of processes, systems and tools that enable planning, execution, and analysis/reporting of regulatory submissions

Desired Experience, Education & Skills:

• Advanced degree preferred (engineering or scientific discipline, MBA)
• Expert in project management methodologies (e.g., PMP, Sigma, Change Management, etc.) and associated toolsets (e.g., MS Project for project planning, MS Excel and/or PowerApps for data analysis and reporting)
• Experience in quality and compliance systems

This is a hybrid role that requires onsite presence three days per week . Of those three days:

• Tuesdays and Wednesdays must be worked onsite at the Philadelphia WeWork facility .
• The third onsite day can be worked at either the Upper Gwynedd, PA or Rahway, NJ site , based on employee preference and team needs.

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 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:

EEOC Know Your Rights

EEOC GINA Supplement

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

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 presence.This 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
$126,500.00 - $199,100.00

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 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 .

You 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:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:
Hybrid

Shift:

Valid Driving License:

Hazardous Material(s):

Required Skills:
Adaptability, Adaptability, Business Processes, Change Management, Communication, Cross-Cultural Awareness, Data Management, Drug Development, Employee Training Programs, FDA Regulations, Management Process, Pharmacovigilance, Policy Implementation, Process Improvements, Project Information Management, Project Management, Project Support, Regulatory Affairs Compliance, Regulatory Compliance, Regulatory Labeling, Regulatory Management, Regulatory Operations, Regulatory Strategies, Regulatory Submissions, Strategic Initiative {+ 5 more}

Preferred Skills:

Job Posting End Date:
08/21/2025
*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: R360434