Job DescriptionThe Associate Director, Regulatory Affairs, supports products in the Oncology therapeutic area as part of a regulatory team. The individual will have excellent communication and collaboration skills and will work closely with a global regulatory lead(s) to help develop and implement a global strategy for registration and/or maintenance of products.
Responsibilities may encompass all aspects of planning and implementation of a global regulatory strategy and regulatory submissions including assisting in preparing submissions, protocol review, and conducting research on regulatory guidance's or competitive intelligence. The individual will have responsibility for driving results for his/her assigned projects through application of regulatory science and strong communication and analytical skills.
Primary Responsibilities:- Assisting in Regulatory Agency communications and submissions, including marketing applications, investigational new drug (IND) applications, pediatric plans and annual or other periodic reports. The individual may also assist or take the lead in tracking, authoring, shepherding and/or review of responses to Agency requests.
- Implementing strategy to develop Agency background packages and documents associated with regulatory submissions for marketing applications.
- Communicating with Agencies and attending Agency meetings as needed to assist the global regulatory lead.
- Participating as an active member on the global regulatory team. Individual will attend cross-functional meetings as required, in collaboration with, and to assist the global regulatory lead.
- Conducting research and review of guidelines, regulatory precedence and competitive intelligence to facilitate development of regulatory strategy. Assist the global regulatory lead in authoring of regulatory strategy documents.
- Collaborating and communicating regulatory strategy as needed to colleagues in Regulatory Operations, Clinical Safety, Labeling, Regulatory Chemistry, Manufacturing and Control (CMC) as well as other functional areas (e.g., clinical research, non-clinical safety assessment).
- Support maintenance (e.g., quality compliance and life cycle management) of oncology programs.
- Support of global regulatory lead in label development.
- Assisting with process improvement initiative.
- Performing regulatory administrative activities, as needed.
Education Minimum Requirements:- Bachelor's Degree, with at least 5 years of relevant experience in the pharmaceutical industry.
- Master's Degree with at least 2 years of relevant experience in pharmaceutical industry.
- M.D. or Ph.D. or other related doctoral degree in biological science, chemistry or related discipline with relevant experience.
Required Experience and Skills:- Experience in drug development
- Prior regulatory experience interacting with a major regulatory agency
Excellent communication skills (both oral and written). - Good organizational skills with a proven ability to simultaneously balance diverse activities for multiple projects.
- Flexibility required.
- Strong scientific and analytical skills with attention to detail.
Preferred Experience and Skills:- Experience with oncology products is highly preferred
#EligibleforERP
Required Skills: Cross-Functional Teamwork, Global Regulatory, Investigational New Drug, Label Development, Life Cycle Planning, Pharmaceutical Industry, Product Registrations, Regulatory Communications, Regulatory Documents, Regulatory Experience, Regulatory Filings, Regulatory Reporting, Regulatory Strategies, Regulatory Submissions, Stakeholder Engagement
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.
The salary range for this role is
$129,000.00 - $203,100.00
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 https://jobs.merck.com/us/en/compensation-and-benefits.
You can apply for this role through https://jobs.merck.com/us/en (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:10%
Flexible Work Arrangements:Hybrid
Shift:Not Indicated
Valid Driving License:No
Hazardous Material(s):n/a
Job Posting End Date:10/17/2026
*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. 
