Scientist, Regulatory Affairs CMC
Job DescriptionThe Scientist is responsible for developing regional CMC strategy, preparation of CMC documentation and execution of regional post-approval CMC submissions and new product registration, serving as a link between regional Local Regulatory Affairs, CMC Product Teams and GRACS CMC teams.
The primary activities may include but are not limited to the following:
Supports CMC regional regulatory strategies for new marketing applications, and post-approval changes Delivers regional regulatory change control assessment identifying regulatory requirements for CMC submissions Prioritizes submissions as per global regulatory strategy coordinating with local regulatory colleagues to support the business Seeks opportunities to maximize submission efficiency and quality to ensure a high rate of submission approvals by Health Authorities Track submissions and approvals ensuring bidirectional communication of status with local affiliates and global CMC teams Prepares documentation to support submission according to local/regional requirements in collaboration with subject matter experts in global CMC teams and local affiliates Prepares timely responses to Health Authority questions ensuring compliance against local/regional regulatory requirements Represents regional CMC on cross-functional teams to ensure mutual understanding of local/regional CMC requirements and program complexities, maintaining close communication with regional and local regulatory colleagues, regional Supply Chain teams and global CMC teams Supports product compliance by ensuring local registrations and lifecycle management align with product manufacturing details Supports continuous process improvement activities within the organization and participate in forums to ensure efficient processes and best practice.
Ensures awareness of regional regulatory policy trends and maintaining the regulatory intelligence repository for regional markets Identifies, communicates, and escalates potential regulatory issues management, as needed Qualification, Skills &
Experience:
Bachelor's (minimum) or graduate degree (preferred) in chemistry, biological science, engineering, or a related field.
Fields of study include Pharmacy, Chemical Engineering, Biology, Microbiology, or Biochemistry or other similar scientific discipline At least two (2) years of relevant experience in research, manufacturing, testing, or regulatory CMC; and/or related fields Proficiency in English; additional language skills are a plus Current Employees apply HERECurrent Contingent Workers apply HERESearch Firm Representatives Please Read CarefullyMerck & 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):
Requisition ID:
R290168#J-18808-Ljbffr Recommended Skills Biochemistry Chemical Engineering Lifecycle Management Manufacturing Microbiology Regulatory Requirements Apply to this job.
Think you're the perfect candidate? Apply on company site Estimated Salary: $20 to $28 per hour based on qualifications.
The primary activities may include but are not limited to the following:
Supports CMC regional regulatory strategies for new marketing applications, and post-approval changes Delivers regional regulatory change control assessment identifying regulatory requirements for CMC submissions Prioritizes submissions as per global regulatory strategy coordinating with local regulatory colleagues to support the business Seeks opportunities to maximize submission efficiency and quality to ensure a high rate of submission approvals by Health Authorities Track submissions and approvals ensuring bidirectional communication of status with local affiliates and global CMC teams Prepares documentation to support submission according to local/regional requirements in collaboration with subject matter experts in global CMC teams and local affiliates Prepares timely responses to Health Authority questions ensuring compliance against local/regional regulatory requirements Represents regional CMC on cross-functional teams to ensure mutual understanding of local/regional CMC requirements and program complexities, maintaining close communication with regional and local regulatory colleagues, regional Supply Chain teams and global CMC teams Supports product compliance by ensuring local registrations and lifecycle management align with product manufacturing details Supports continuous process improvement activities within the organization and participate in forums to ensure efficient processes and best practice.
Ensures awareness of regional regulatory policy trends and maintaining the regulatory intelligence repository for regional markets Identifies, communicates, and escalates potential regulatory issues management, as needed Qualification, Skills &
Experience:
Bachelor's (minimum) or graduate degree (preferred) in chemistry, biological science, engineering, or a related field.
Fields of study include Pharmacy, Chemical Engineering, Biology, Microbiology, or Biochemistry or other similar scientific discipline At least two (2) years of relevant experience in research, manufacturing, testing, or regulatory CMC; and/or related fields Proficiency in English; additional language skills are a plus Current Employees apply HERECurrent Contingent Workers apply HERESearch Firm Representatives Please Read CarefullyMerck & 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):
Requisition ID:
R290168#J-18808-Ljbffr Recommended Skills Biochemistry Chemical Engineering Lifecycle Management Manufacturing Microbiology Regulatory Requirements Apply to this job.
Think you're the perfect candidate? Apply on company site Estimated Salary: $20 to $28 per hour based on qualifications.
|
|
 | |
