Regulatory Affairs Specialist/Senior Regulatory Affairs Specialist - Home Based - West Coast

Submission for the position: Regulatory Affairs Specialist/Senior Regulatory Affairs Specialist - Home Based - West Coast - (Job Number: 177866)We are vital links between an idea for a new medicine and the people who need it. We are the people of PPD — thousands of employees in locations worldwide connected by tenacity and passion for our purpose: to improve health. You will be joining a truly collaborative and winning culture as we strive to bend the time and cost curve of delivering life-saving therapies to patients.

If you’re a strategic thinker, planner and multitasker as comfortable working independently as you are on a team in delivering compliant deliverables based on solid judgment, PPD is the place to be. Our global regulatory experts contribute the regulatory strategy and knowledge to help our clients navigate the challenging regulatory environment — and help get life-changing therapies to patients faster.

As a Regulatory Affairs Specialist/Senior Regulatory Affairs Specialist, you will provide innovative regulatory solutions to our clients.

At PPD we hire the best, develop ourselves and each other, and recognize the power of being one team. We offer continued career advancement opportunities, award winning training and benefits focused on the health and wellbeing of our employees.

Summarized Purpose:

Provides innovative solutions including regulatory expertise and client interface to provide strategic intelligence, and guidance supporting product development from preclinical through registration and product optimization. Provides strategic, expedient and efficient preparation of client deliverables that meet current local, regional and ICH regulatory and technical requirements. Acts as liaison with internal and external clients in the provision and marketing of these services.

Essential Functions: Supports the preparation of documentation and submissions under guidance. Coordinates and manages client deliverables supporting regulatory compliance. Liaises with internal and external clients in the tracking and status update of project plans and overall support of projects. Assists with project budgeting/forecasting. Maintains knowledge and understanding of SOPs, client SOPs/directives, and current regulatory guidelines. Assists in business development and pricing of projects for the department. Evaluates client needs in relationship to overall project timelines, quality and delivery. Engages other project team members, functional units and/or management as necessary to deliver final product, and resolve/mitigate identified issues or barriers to delivery as needed.

#LI-JN1

#LI-Remote

We are vital links between an idea for a new medicine and the people who need it. We are the people of PPD — thousands of employees in locations worldwide connected by tenacity and passion for our purpose: to improve health. You will be joining a truly collaborative and winning culture as we strive to bend the time and cost curve of delivering life-saving therapies to patients.

If you’re a strategic thinker, planner and multitasker as comfortable working independently as you are on a team in delivering compliant deliverables based on solid judgment, PPD is the place to be. Our global regulatory experts contribute the regulatory strategy and knowledge to help our clients navigate the challenging regulatory environment — and help get life-changing therapies to patients faster.

As a Regulatory Affairs Specialist/Senior Regulatory Affairs Specialist, you will provide innovative regulatory solutions to our clients.

At PPD we hire the best, develop ourselves and each other, and recognize the power of being one team. We offer continued career advancement opportunities, award winning training and benefits focused on the health and wellbeing of our employees.

Summarized Purpose:

Provides innovative solutions including regulatory expertise and client interface to provide strategic intelligence, and guidance supporting product development from preclinical through registration and product optimization. Provides strategic, expedient and efficient preparation of client deliverables that meet current local, regional and ICH regulatory and technical requirements. Acts as liaison with internal and external clients in the provision and marketing of these services.

Essential Functions: Supports the preparation of documentation and submissions under guidance. Coordinates and manages client deliverables supporting regulatory compliance. Liaises with internal and external clients in the tracking and status update of project plans and overall support of projects. Assists with project budgeting/forecasting. Maintains knowledge and understanding of SOPs, client SOPs/directives, and current regulatory guidelines. Assists in business development and pricing of projects for the department. Evaluates client needs in relationship to overall project timelines, quality and delivery. Engages other project team members, functional units and/or management as necessary to deliver final product, and resolve/mitigate identified issues or barriers to delivery as needed.

#LI-JN1

#LI-Remote

Education and Experience:

Bachelor's degree or equivalent and relevant formal academic / vocational qualificationPrevious experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2 years).

Knowledge, Skills and Abilities:

​​​​​​Good English language (written and oral) communication skills as well as local language where applicable

Good attention to detail and quality as well as editorial/proofreading skills

Good interpersonal skills to work effectively in a team environment

Good computer skills including the use of Microsoft Word, Excel, Power Point; capable of learning new technologies

Basic organizational, time management, and planning skills to create and follow timelines, conduct long-range planning, adapt to changing priorities and handle multiple projects

Good negotiation skills

Capable of working independently with direction and exercising independent judgment

Capable of independently assessing sponsor regulatory needs and working with project team members in producing compliant deliverables

Basic knowledge of global/regional/national country requirements/regulatory affairs procedures for clinical trial authorization, licensing, lifecycle management

Basic understanding of medical terminology, statistical concepts, and guidelinesGood analytical, investigative and problem-solving skills

Capable of interpreting data

Working Environment:

PPD values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role:

Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.

Able to work upright and stationary for typical working hours.

Ability to use and learn standard office equipment and technology with proficiency.

Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.

May require travel. (Recruiter will provide more details.)

PPD Defining Principles:

- We have a strong will to win - We earn our customer’s trust - We are game changers - We do the right thing - We are one PPD

If you resonate with our five principles above, and ultimately wish to accelerate the delivery of safe and effective therapeutics for some of the world’s most urgent health needs, then please submit your application – we’d love to hear from you.

Education and Experience:

Bachelor's degree or equivalent and relevant formal academic / vocational qualificationPrevious experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2 years).

Knowledge, Skills and Abilities:

​​​​​​Good English language (written and oral) communication skills as well as local language where applicable

Good attention to detail and quality as well as editorial/proofreading skills

Good interpersonal skills to work effectively in a team environment

Good computer skills including the use of Microsoft Word, Excel, Power Point; capable of learning new technologies

Basic organizational, time management, and planning skills to create and follow timelines, conduct long-range planning, adapt to changing priorities and handle multiple projects

Good negotiation skills

Capable of working independently with direction and exercising independent judgment

Capable of independently assessing sponsor regulatory needs and working with project team members in producing compliant deliverables

Basic knowledge of global/regional/national country requirements/regulatory affairs procedures for clinical trial authorization, licensing, lifecycle management

Basic understanding of medical terminology, statistical concepts, and guidelinesGood analytical, investigative and problem-solving skills

Capable of interpreting data

Working Environment:

PPD values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role:

Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.

Able to work upright and stationary for typical working hours.

Ability to use and learn standard office equipment and technology with proficiency.

Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.

May require travel. (Recruiter will provide more details.)

PPD Defining Principles:

- We have a strong will to win - We earn our customer’s trust - We are game changers - We do the right thing - We are one PPD

If you resonate with our five principles above, and ultimately wish to accelerate the delivery of safe and effective therapeutics for some of the world’s most urgent health needs, then please submit your application – we’d love to hear from you.

Submission for the position: Regulatory Affairs Specialist/Senior Regulatory Affairs Specialist - Home Based - West Coast - (Job Number: 177866)