Senior/Principal Regulatory Affairs Specialist - Global Reg Affairs Strategy - Home Based West Coast US and Canada

Submission for the position: Senior/Principal Regulatory Affairs Specialist - Global Reg Affairs Strategy - Home Based West Coast US and Canada - (Job Number: 179445)Senior/Principal Regulatory Affairs Specialist - Global Reg Affairs Strategy - Home Based West Coast US and Canada Senior/Principal Regulatory Affairs Specialist - Global Reg Affairs Strategy - Home Based West Coast US and Canada 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:

Serves a s a sen i or co n ta c t i n provid in g i nn o v a tiv e sol u t ion s i nc lu ding reg u la tory e x pe rt ise , in te ra c tin g w ith cl ie n ts to provide stra t e gic regulat ory i n te lligen c e , a n d guidan c e su pp ortin g p roduc t de v e lopme n t f rom pre c li n ic a l t h rou g h re g istra tion a n d pr od uc t opt im i za tion . Prov i de s stra te gic, e xpe die n t a n d ef f ic ie n t pre pa ra tion of c lie n t de liv e r a ble s th a t mee t cu rre n t loc a l, regiona l a n d I CH re g u la t ory a n d te c hn i c a l re quireme n ts. Act s a s lia iso n w ith in te r n a l a n d e xte rnal cl ie n ts i n t h e pro v isio n a n d ma rket in g of t h e se servic e s.

Essential Functions: Prepares and reviews regulatory submissions. Provides regulatory strategy and/or technical advice to internal and external clients, 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 a timely 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:

Serves a s a sen i or co n ta c t i n provid in g i nn o v a tiv e sol u t ion s i nc lu ding reg u la tory e x pe rt ise , in te ra c tin g w ith cl ie n ts to provide stra t e gic regulat ory i n te lligen c e , a n d guidan c e su pp ortin g p roduc t de v e lopme n t f rom pre c li n ic a l t h rou g h re g istra tion a n d pr od uc t opt im i za tion . Prov i de s stra te gic, e xpe die n t a n d ef f ic ie n t pre pa ra tion of c lie n t de liv e r a ble s th a t mee t cu rre n t loc a l, regiona l a n d I CH re g u la t ory a n d te c hn i c a l re quireme n ts. Act s a s lia iso n w ith in te r n a l a n d e xte rnal cl ie n ts i n t h e pro v isio n a n d ma rket in g of t h e se servic e s.

Essential Functions: Prepares and reviews regulatory submissions. Provides regulatory strategy and/or technical advice to internal and external clients, 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 a timely 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:

Ba ch e lor' s de gre e or e qui v a le n t a n d re le v a n t f orma l a c a de mic / v oc a tio n a l qualif ic a tion

P re v iou s e x pe rie nc e t h a t provides th e kn ow le dge , sk ills , a n d a bilit ie s to pe rf o rm th e j ob (c ompa ra ble t o

5 y ea rs) .

In so m e c ase s an e qu ivale n cy , c on sis tin g of a c om bi n ati o n of ap propri at e e du c ati on , train in g an d/or direc tl y re lat e d e xpe rience , wil l be c on sidere d su ff icie n t for an in dividu al t o m ee t th e re qu irem e n ts of t h e role .

Knowle dge , S k ills a n d A bi litie s : Strong E n g lish la n guag e (w rit te n a n d ora l) comm un i c a tion sk il ls a s we ll a s loc a l la n guag e w h e re a pplica ble So lid a tte n tion t o de ta il a n d quali ty a s we ll a s stron g e dit oria l/proof rea ding sk ills Strong i n te rpe rson a l s k ills t o w ork ef f e c ti v e ly i n a tea m e nv iro n me n t a n d a c t a s a l ia ison w ith ot h e r de pa rt me n ts So lid c omp u te r s k ills i nc lu di n g t h e u se of Mi c ros of t W o rd, E xc e l, Powe r P oi n t; c a pa ble of lea rnin g n e w te chn ol ogie s So lid orga n i za tion a l, tim e m a n a ge me n t, a n d pla n n in g s k ills to c rea te a n d f ollow t i me lin e s, c o n du c t lon g-ra n ge pla nn i n g, a da pt to ch a n gi n g pr iorit ie s a n d h a n dle m u ltiple pro j e c ts So lid neg otia tion s k ills Ca pa ble of w ork i n g indep e n de n tly a n d e xercisi n g i n de pe n de n t j u dgme n t t o a sses s spon s or re gulat or y n ee ds a n d w ork w ith pro j e c t tea m me mbe rs t o produc i n g complia n t de liv e ra ble s So lid u n de rsta n di ng o f glob a l/re giona l/n a tion a l c o un tr y re quireme n ts/re gulat or y af f a irs pr oc e d u re s f or cli n ic a l t ria l a u t h oriza tio n , lic e n sin g , lif e c y c le ma n a ge me n t; good k n ow le dge o f ICH a n d other globa l re gulat ory g u ide lin e s ; ba sic un de rsta n di n g o f a r e gulat ory spe c ia lity a rea s, s uc h a s p re c lin i c a l, c lin i c a l, CMC, p u blis h in g, e t c . So lid u n de rsta n di n g o f me d ic a l te rm in olog y , sta tistic a l c on c e pt s, an d g u ide lin e s Strong a n a l y tic a l, i nv e stiga t iv e a n d pr oble m - solv i n g s k il ls Workin g k n ow le dge of bud ge tin g a n d f ore c a stin g

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:

Ba ch e lor' s de gre e or e qui v a le n t a n d re le v a n t f orma l a c a de mic / v oc a tio n a l qualif ic a tion

P re v iou s e x pe rie nc e t h a t provides th e kn ow le dge , sk ills , a n d a bilit ie s to pe rf o rm th e j ob (c ompa ra ble t o

5 y ea rs) .

In so m e c ase s an e qu ivale n cy , c on sis tin g of a c om bi n ati o n of ap propri at e e du c ati on , train in g an d/or direc tl y re lat e d e xpe rience , wil l be c on sidere d su ff icie n t for an in dividu al t o m ee t th e re qu irem e n ts of t h e role .

Knowle dge , S k ills a n d A bi litie s : Strong E n g lish la n guag e (w rit te n a n d ora l) comm un i c a tion sk il ls a s we ll a s loc a l la n guag e w h e re a pplica ble So lid a tte n tion t o de ta il a n d quali ty a s we ll a s stron g e dit oria l/proof rea ding sk ills Strong i n te rpe rson a l s k ills t o w ork ef f e c ti v e ly i n a tea m e nv iro n me n t a n d a c t a s a l ia ison w ith ot h e r de pa rt me n ts So lid c omp u te r s k ills i nc lu di n g t h e u se of Mi c ros of t W o rd, E xc e l, Powe r P oi n t; c a pa ble of lea rnin g n e w te chn ol ogie s So lid orga n i za tion a l, tim e m a n a ge me n t, a n d pla n n in g s k ills to c rea te a n d f ollow t i me lin e s, c o n du c t lon g-ra n ge pla nn i n g, a da pt to ch a n gi n g pr iorit ie s a n d h a n dle m u ltiple pro j e c ts So lid neg otia tion s k ills Ca pa ble of w ork i n g indep e n de n tly a n d e xercisi n g i n de pe n de n t j u dgme n t t o a sses s spon s or re gulat or y n ee ds a n d w ork w ith pro j e c t tea m me mbe rs t o produc i n g complia n t de liv e ra ble s So lid u n de rsta n di ng o f glob a l/re giona l/n a tion a l c o un tr y re quireme n ts/re gulat or y af f a irs pr oc e d u re s f or cli n ic a l t ria l a u t h oriza tio n , lic e n sin g , lif e c y c le ma n a ge me n t; good k n ow le dge o f ICH a n d other globa l re gulat ory g u ide lin e s ; ba sic un de rsta n di n g o f a r e gulat ory spe c ia lity a rea s, s uc h a s p re c lin i c a l, c lin i c a l, CMC, p u blis h in g, e t c . So lid u n de rsta n di n g o f me d ic a l te rm in olog y , sta tistic a l c on c e pt s, an d g u ide lin e s Strong a n a l y tic a l, i nv e stiga t iv e a n d pr oble m - solv i n g s k il ls Workin g k n ow le dge of bud ge tin g a n d f ore c a stin g

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 - Global Reg Affairs Strategy - Home Based West Coast US and Canada - (Job Number: 179445)Senior/Principal Regulatory Affairs Specialist - Global Reg Affairs Strategy - Home Based West Coast US and Canada