Associate Director, Regulatory Affairs
Associate Director, Regulatory Affairs
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$ 126500 - 199100
1 Vacancy
Job Description
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 toproviding 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 - Bachelors 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 presencethree days per week. Of those three days:
- Tuesdays and Wednesdaysmust be workedonsite at the Philadelphia WeWork facility.
- Thethird onsite daycan be worked ateither 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 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 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 - $199100.00This 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:
RegularRelocation:
VISA Sponsorship:
Travel Requirements:
Flexible Work Arrangements:
HybridShift:
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 morePreferred Skills:
Job Posting End Date:
08/21/2025*A job posting is effective until 11:59:59PM on the day BEFOREthe 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
Employment Type
Full-Time
