Senior Regulatory Affairs Specialist

Job Description

Are you passionate about navigating the complex world of international pharmaceutical regulations? Our company is seeking a dedicated Sr. Regulatory Affairs Specialist to join our Regulatory Affairs Department. If you're ready to make a global impact and drive compliance excellence, we want you on our team.

Job Description

Under the direction of the Regulatory Manager, the incumbent:

• Manages regulatory activities for new products in order to get products to market according to company plans.

  
  

• Handles timely submission and follow-up of post-approval labeling and CMC variations.

  
  

• Develops drives and finalizes all applications for GMP/new product registrations in line with local regulatory requirements and with marketing plans.

  
  

• Manages the renewal process in liaison with the HQs, ensuring that the renewal files are prepared, submitted and approved in due time.

  
  

• Handles the control of packaging components artworks developed by labeling coordinator.

  
  

• Updates and implements local regulatory procedures in a timely manner, in close synergy with the regional organization.

  
  

• Plans and tracks all regulatory actions to document and ensure full compliance with relevant legislation and with internal procedures.

  
  

• Pro-actively shares intelligence on competitive products, generics/copies, as well as on emerging regulations.

  
  

• Keeps abreast of trends and legislation, at both national and international levels.

  
  

• Provides advice and recommendations to Management and to regional organization on regulatory policy and applicable strategy in order to accelerate regulatory approvals while securing compliance.

  
  

Requirements

• Graduated from the Pharmacy, Chemistry, Chemical Engineering and Biology departments of universities,

  
  

• At least 3 years of experience in the registration of medicinal products

  
  

• Has good command of English,

  
  

• Successful in human relations and open to communication,

  
  

Current Employees apply HERE

Current Contingent Workers apply HERE

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:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

*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.