Associate Specialist - Regulatory Affairs (Hybrid) Job at Merck, Ludlow, PA

  • Merck
  • Ludlow, PA

Job Description

Associate Specialist supporting regulatory submissions and planning at a pharmaceutical company. The role involves managing FDA documentation, tracking deliverables, and coordinating with cross-functional teams in a hybrid Philadelphia office setting.

Responsibilities

  • Support creation of FDA cover letters, forms, and submission plans
  • Track timelines and deliverables for regulatory submission components
  • Manage regulatory documents and maintain accountability for tracking systems
  • Collaborate with colleagues across departments to coordinate regulatory activities
  • Participate in process improvements and training to build regulatory expertise

Requirements

  • High school diploma or equivalent
  • Strong verbal and written communication across organizational levels
  • Proficiency with Microsoft Office; advanced Excel and Word skills preferred
  • Demonstrated problem-solving ability and independent work capability
  • Highly organized with meticulous attention to detail
  • Experience with document control systems and regulatory processes desired

Compensation: $71,900–$113,200 base

Job Tags

Work at office

Similar Jobs

Young Mann, Inc.

Window Cleaning Professional Job at Young Mann, Inc.

 ...k) matching ~ Company car ~ Competitive salary ~ Free uniforms ~ Paid time off ~ Training & development ~401(k) Fish Window Cleaning is hiring for window cleaners in the Montgomery County area. Get hired this week with Paid Training $16-$24+ hourly... 

Advanced Technology Services

Material Handler Job at Advanced Technology Services

 ...ascertain materials or containers to be moved; moves material in warehouse and other areas as needed; loads and unloads materials onto or...  .... Records material moves in computer system; Performs shipping data entry into computer system; performs basic tracking and reporting... 

ATT

Retail Store Manager: Lead Team & Drive Customer Experience Job at ATT

 ...AT&T, Warner Robins, GA, seeks a Store Manager to lead daily store operations, drive sales, and coach a team of retail consultants. You will manage merchandising, launches, and events while ensuring outstanding customer service and outcomes.The role offers a comprehensive... 

SOFLO Domestics

Full-Time Private Housekeeper/Cook Single-Person Household Highland Beach, FL Job at SOFLO Domestics

 ...experienced and detail-oriented Full-Time Housekeeper/Cook to maintain a household and prepare organic, healthy, vegetarian lunch and dinner for a...  .... Requirements: Minimum of 3-5 years of high-end private household experience as a Housekeeper/Cook Ability to follow... 

Fran's ExploreMore Travel

WFH Family Vacation & Theme Park Coordinator Job at Fran's ExploreMore Travel

 ...basic computer skills (email, web browsing, Microsoft Office or Google Workspace) Ability to manage multiple tasks and meet...  ...experience is a plus but not required Benefits Flexible work-from-home schedule Supportive and collaborative team environment Opportunity...