sr. Regulatory writerCertara
Workplace: MetroManila, Manila, Makati
Salary: Agreement
Work form: Full time
Posting Date: 09/11/2025
Deadline: 09/01/2022
Job Title: Senior Regulatory Writer - PHARMACOVIGILANCE
Business Unit: Regulatory Services
Location: Makati City, Philippines
Job Overview:
Senior Regulatory Writer prepare high quality documentation for regulatory submissions in order to help streamline the regulatory documentation process for our clients. Senior Regulatory Writer is a major contributor to document authorship for a variety of documents across different service lines. The Senior Regulatory Writer will be the project leader and authoring contributor for all types of client engagements while mentoring others in the knowledge of authoring regulatory documents.
Responsibilities:
Lead a project team, and actively participate in development and writing of high-quality documents (DSUR, PSUR/PBRER, signal evaluation reports, RMP documents)
Author documents per client specifications, templates, style guides, and other guidance documents
Author documents per regulatory authority guidelines and requirements
Act as client advisor, working collaboratively and developing a strong relationship of trust built upon consistent and reliable communication; communicate ideas and strategies to produce a successful end result
Practice blameless problem solving, taking broad perspectives in resolving issues to prevent negative impact to work
Manage budget for a low complexity project, including all contributors (writers, editors)
Usher documents through the review process, conduct comment resolutions meetings (CRMs) and successfully lead a project team to a consensus
Maintain collaborative, proactive, and effective communication with both client and internal teams
Lead project-related meetings and teleconferences
Provide coaching to junior staff for study level documents as well as submission level documents and ensure all staff comply with company standard operating procedures (SOPs) and training requirements
Education, Experience, Training, and Knowledge:
Bachelor's degree
3-5+ years of regulatory writing experience with pharmacovigilance focus such as DSUR, PSUR/PBRER, signal evaluation reports, RMP documents
Understand regulatory requirements for different phases of development and different regulatory pathways
Knowledge of global health authority requirements
Certara bases all employment-related decision on merit, taking into consideration qualifications, skills, achievement, and performance. We treat all applicants and employees without regard to personal characteristics such as race, color, ethnicity, religion, sex, sexual orientation, age, nationality, marital status, pregnancy, physical or mental condition, genetic information, military service, or other characteristic protected by law.
Certara
Business Unit: Regulatory Services
Location: Makati City, Philippines
Job Overview:
Senior Regulatory Writer prepare high quality documentation for regulatory submissions in order to help streamline the regulatory documentation process for our clients. Senior Regulatory Writer is a major contributor to document authorship for a variety of documents across different service lines. The Senior Regulatory Writer will be the project leader and authoring contributor for all types of client engagements while mentoring others in the knowledge of authoring regulatory documents.
Responsibilities:
Lead a project team, and actively participate in development and writing of high-quality documents (DSUR, PSUR/PBRER, signal evaluation reports, RMP documents)
Author documents per client specifications, templates, style guides, and other guidance documents
Author documents per regulatory authority guidelines and requirements
Act as client advisor, working collaboratively and developing a strong relationship of trust built upon consistent and reliable communication; communicate ideas and strategies to produce a successful end result
Practice blameless problem solving, taking broad perspectives in resolving issues to prevent negative impact to work
Manage budget for a low complexity project, including all contributors (writers, editors)
Usher documents through the review process, conduct comment resolutions meetings (CRMs) and successfully lead a project team to a consensus
Maintain collaborative, proactive, and effective communication with both client and internal teams
Lead project-related meetings and teleconferences
Provide coaching to junior staff for study level documents as well as submission level documents and ensure all staff comply with company standard operating procedures (SOPs) and training requirements
Education, Experience, Training, and Knowledge:
Bachelor's degree
3-5+ years of regulatory writing experience with pharmacovigilance focus such as DSUR, PSUR/PBRER, signal evaluation reports, RMP documents
Understand regulatory requirements for different phases of development and different regulatory pathways
Knowledge of global health authority requirements
Certara bases all employment-related decision on merit, taking into consideration qualifications, skills, achievement, and performance. We treat all applicants and employees without regard to personal characteristics such as race, color, ethnicity, religion, sex, sexual orientation, age, nationality, marital status, pregnancy, physical or mental condition, genetic information, military service, or other characteristic protected by law.
Certara
Other Info
Makati City, Metro Manila
Permanent
Full-time
Permanent
Full-time
Submit profile
Certara
About the company
Position sr. Regulatory writer recruited by the company Certara at MetroManila, Manila, Makati, Joboko automatically collects the salary of , finds more jobs on Sr. Regulatory Writer or Certara company in the links above