Senior/Principal Regulatory Affairs Specialist - Medical Device - Home Based

Submission for the position: Senior/Principal Regulatory Affairs Specialist - Medical Device - Home Based - (Job Number: 184459)

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.

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.

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

Summarized Purpose:

Servesas a senior contactin providinginnovative solutionsincluding regulatoryexpertise, interactingwith clients to provide strategic regulatoryintelligence,and guidance supportingproduct developmentfrom preclinicalthrough registrationand product optimization. Provides strategic,expedientandefficient preparation ofclient deliverables thatmeet current local, regionalandICH regulatoryandtechnical requirements. Actsas liaisonwith internalandexternal clientsinthe provisionandmarketing ofthese services.

Essential Functions: Prepares and reviews regulatory submissions. Provides regulatory strategy and/or technical advice to internal and externalclients, and acts as a liaison in executing strategies. Leads the development and implementation of project-specific processes for sponsors. Collaborates extensively with other departments, regulatory consultants, and regulatory authorities. Assists in identifying and recognizing out of scope activities in a contract in atimely manner and liaises with other departments to follow through on all aspects of contract modifications. Provides training and guidance to junior team members as appropriate. Participates in project launch meetings, review meetings and project team meetings. Supports business development activities, including project budgeting/forecasting.

#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.

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.

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

Summarized Purpose:

Servesas a senior contactin providinginnovative solutionsincluding regulatoryexpertise, interactingwith clients to provide strategic regulatoryintelligence,and guidance supportingproduct developmentfrom preclinicalthrough registrationand product optimization. Provides strategic,expedientandefficient preparation ofclient deliverables thatmeet current local, regionalandICH regulatoryandtechnical requirements. Actsas liaisonwith internalandexternal clientsinthe provisionandmarketing ofthese services.

Essential Functions: Prepares and reviews regulatory submissions. Provides regulatory strategy and/or technical advice to internal and externalclients, and acts as a liaison in executing strategies. Leads the development and implementation of project-specific processes for sponsors. Collaborates extensively with other departments, regulatory consultants, and regulatory authorities. Assists in identifying and recognizing out of scope activities in a contract in atimely manner and liaises with other departments to follow through on all aspects of contract modifications. Provides training and guidance to junior team members as appropriate. Participates in project launch meetings, review meetings and project team meetings. Supports business development activities, including project budgeting/forecasting.

#LI-JN1

#LI-Remote

Education and Experience:

Bachelor's degree orequivalentand relevantformalacademic /vocational qualification

Previousexperiencethat provides theknowledge, skills,andabilities to performthejob (comparableto

5 years).

In somecases anequivalency,consisting of acombination of appropriateeducation, training and/or directly relatedexperience, will beconsidered sufficient for an individualtomeetthe requirements ofthe role.

Knowledge,SkillsandAbilities: StrongEnglish language (writtenand oral) communication skillsaswellas local languagewhereapplicable Solidattentionto detailand qualityaswellas strongeditorial/proofreading skills Stronginterpersonalskillstoworkeffectivelyin ateamenvironmentandactas aliaisonwith other departments Solidcomputerskillsincludingtheuse of MicrosoftWord,Excel, PowerPoint;capable of learningnew technologies Solid organizational, timemanagement,and planningskills tocreateandfollowtimelines,conduct long-range planning,adapt tochanging prioritiesandhandlemultiple projects Solid negotiationskills Capable ofworking independentlyandexercisingindependentjudgmenttoassess sponsor regulatoryneedsandworkwith projectteammembersto producing compliant deliverables Solidunderstandingof global/regional/nationalcountry requirements/regulatoryaffairs proceduresfor clinicaltrialauthorization, licensing, lifecyclemanagement; goodknowledgeof ICHand other global regulatoryguidelines; basicunderstandingof aregulatory specialityareas,suchaspreclinical,clinical, CMC,publishing,etc. Solidunderstandingofmedicalterminology, statisticalconcepts, andguidelines Stronganalytical,investigativeand problem-solvingskills Workingknowledge of budgetingandforecasting

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 orequivalentand relevantformalacademic /vocational qualification

Previousexperiencethat provides theknowledge, skills,andabilities to performthejob (comparableto

5 years).

In somecases anequivalency,consisting of acombination of appropriateeducation, training and/or directly relatedexperience, will beconsidered sufficient for an individualtomeetthe requirements ofthe role.

Knowledge,SkillsandAbilities: StrongEnglish language (writtenand oral) communication skillsaswellas local languagewhereapplicable Solidattentionto detailand qualityaswellas strongeditorial/proofreading skills Stronginterpersonalskillstoworkeffectivelyin ateamenvironmentandactas aliaisonwith other departments Solidcomputerskillsincludingtheuse of MicrosoftWord,Excel, PowerPoint;capable of learningnew technologies Solid organizational, timemanagement,and planningskills tocreateandfollowtimelines,conduct long-range planning,adapt tochanging prioritiesandhandlemultiple projects Solid negotiationskills Capable ofworking independentlyandexercisingindependentjudgmenttoassess sponsor regulatoryneedsandworkwith projectteammembersto producing compliant deliverables Solidunderstandingof global/regional/nationalcountry requirements/regulatoryaffairs proceduresfor clinicaltrialauthorization, licensing, lifecyclemanagement; goodknowledgeof ICHand other global regulatoryguidelines; basicunderstandingof aregulatory specialityareas,suchaspreclinical,clinical, CMC,publishing,etc. Solidunderstandingofmedicalterminology, statisticalconcepts, andguidelines Stronganalytical,investigativeand problem-solvingskills Workingknowledge of budgetingandforecasting

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: Senior/Principal Regulatory Affairs Specialist - Medical Device - Home Based - (Job Number: 184459)