Regulatory Affairs Manager (Functional Service Partnership) - Contract Opportunity

Submission for the position: Regulatory Affairs Manager (Functional Service Partnership) - Contract Opportunity - (Job Number: 169543)

PLEASE SUBMIT ENGLISH LANGUAGE RESUMES ONLY

*Various Seniority Levels

* Home-Based/Remote Based Contract Opportunity

*Full Time (FTE 1.0)

*6 month duration

Do you prefer flexible work options that allow you to work as a contractor, while also being immersed in the PPD Culture?

Apply today to learn more about current and upcoming contractor opportunities through our Functional Service Partnership team.

Functional Service Partnership Homepage: https://www.ppd.com/our-solutions/clinical/fsp/

Position Summary

Provides technical/project leadership over a region(s), providing innovative solutions including regulatory affairs expertise and client interface to provide strategic regulatory 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.

PLEASE SUBMIT ENGLISH LANGUAGE RESUMES ONLY

*Various Seniority Levels

* Home-Based/Remote Based Contract Opportunity

*Full Time (FTE 1.0)

*6 month duration

Do you prefer flexible work options that allow you to work as a contractor, while also being immersed in the PPD Culture?

Apply today to learn more about current and upcoming contractor opportunities through our Functional Service Partnership team.

Functional Service Partnership Homepage: https://www.ppd.com/our-solutions/clinical/fsp/

Position Summary

Provides technical/project leadership over a region(s), providing innovative solutions including regulatory affairs expertise and client interface to provide strategic regulatory 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

Provides senior review and advice to prepare regional regulatory submissions and ensure high quality standards that meet or exceed client expectations, local and regional requirements. Acts as subject matter expert in providing regulatory strategy advice and technical expertise to internal and external clients and for key client projects of moderate to high complexity. Provides internal clients with up-to-date legislation and guidance as it becomes available. Ensures quality performance for key/managed projects. Manages project budgeting/forecasting functions. Identifies and recognizes 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. Collaborates with business development in pricing and securing new business by making presentations to clients, and develops proposal texts and budgets in collaboration with other departments. Provides matrix/project leadership, training and guidance to junior team members. Ensures compliance with relevant organizational and regulatory SOPs and WPDs. Participates in launch meetings, review meetings and project team meetings.

Education and Experience Bachelor's degree or equivalent and relevant formal academic / vocational qualification Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 9 years). In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.

Knowledge, Skills, and Abilities Excellent English language (written and oral) communication skills as well as local language where applicable Excellent attention to detail and quality as well as excellent editorial/proofreading skills Exceptional interpersonal skills to work effectively in a team environment and act as a liaison with other departments Advanced computer skills including the use of Microsoft Word, Excel, Power Point; capable of learning new technologies Strong organizational, time management, and planning skills to create and follow timelines, conduct long-range planning, adapt to changing priorities and handle multiple projects Excellent negotiation skills Capable of working independently and exercising independent judgment to assess sponsor regulatory needs and work with project team members to producing compliant deliverables Excellent understanding of global/regional/national country requirements/regulatory affairs procedures for clinical trial authorization, licensing, lifecycle management; expert knowledge of ICH and other global regulatory guidelines; advanced understanding of a regulatory specialty areas, such as preclinical, clinical, CMC, publishing, etc. Superb understanding of medical terminology, statistical concepts, and guidelines Excellent analytical, investigative and problem-solving skills Excellent understanding of budgeting and forecasting

PPD is an inclusive equal employment opportunity company. We value all people regardless of background, experience and abilities.

PPD values the health and well-being 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.)

Essential Functions

Provides senior review and advice to prepare regional regulatory submissions and ensure high quality standards that meet or exceed client expectations, local and regional requirements. Acts as subject matter expert in providing regulatory strategy advice and technical expertise to internal and external clients and for key client projects of moderate to high complexity. Provides internal clients with up-to-date legislation and guidance as it becomes available. Ensures quality performance for key/managed projects. Manages project budgeting/forecasting functions. Identifies and recognizes 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. Collaborates with business development in pricing and securing new business by making presentations to clients, and develops proposal texts and budgets in collaboration with other departments. Provides matrix/project leadership, training and guidance to junior team members. Ensures compliance with relevant organizational and regulatory SOPs and WPDs. Participates in launch meetings, review meetings and project team meetings.

Education and Experience Bachelor's degree or equivalent and relevant formal academic / vocational qualification Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 9 years). In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.

Knowledge, Skills, and Abilities Excellent English language (written and oral) communication skills as well as local language where applicable Excellent attention to detail and quality as well as excellent editorial/proofreading skills Exceptional interpersonal skills to work effectively in a team environment and act as a liaison with other departments Advanced computer skills including the use of Microsoft Word, Excel, Power Point; capable of learning new technologies Strong organizational, time management, and planning skills to create and follow timelines, conduct long-range planning, adapt to changing priorities and handle multiple projects Excellent negotiation skills Capable of working independently and exercising independent judgment to assess sponsor regulatory needs and work with project team members to producing compliant deliverables Excellent understanding of global/regional/national country requirements/regulatory affairs procedures for clinical trial authorization, licensing, lifecycle management; expert knowledge of ICH and other global regulatory guidelines; advanced understanding of a regulatory specialty areas, such as preclinical, clinical, CMC, publishing, etc. Superb understanding of medical terminology, statistical concepts, and guidelines Excellent analytical, investigative and problem-solving skills Excellent understanding of budgeting and forecasting

PPD is an inclusive equal employment opportunity company. We value all people regardless of background, experience and abilities.

PPD values the health and well-being 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.)

US-IL-North Chicago, US-CA-San Carlos, US-NJ-Pennington-FSP Hopewell NJ, US-Ohio-Cincinnati, US-AZ-Phoenix, US-TX-Austin, US-NJ-Pennington, US-NC-Wilmington, US-CA-Foster City-FSP Foster City CA, US-MA-Waltham, US-TX-Austin-Austin TX Metro Center Dr 300, US-PA-Philadelphia-FSP Philadelphia PA, US-NJ-Rahway, US-MD-Rockville-FSP Rockville MD, US-PA-Collegeville-FSP Collegeville PA, US-FL-Orlando-Orlando FL, US-KY-Highland Heights, US-MA-Boston, US-Maryland, US-MA-Devens, US-North Carolina, US-MA-Boston-FSP Boston MA, US-MD-Bethesda, US-MA-Cambridge-FSP2 Cambridge, MA, US-FL-Orlando-Orlando Compass Clinic, US-WI-Middleton, US-PA-Philadelphia-FSP Phila PA Crescent Drive, US-FL-Melbourne, US-PA-Horsham, US-IL-Chicago, US-PA-Blue Bell, US-Arizona, US-NJ-Kenilworth-FSP Kenilworth NJ, US-WA-Seattle, US-PA-King of Prussia-FSP King of Prussia PA, US-Nevada, US-NY-East Syracuse, US-Michigan, US-Michigan-Detroit, US-Washington, US-FL-The Villages-The Villages, US-District of Columbia-Washington, DC, US-New Jersey, US-NC-Morrisville, US-Minnesota, US-NJ-Princeton-FSP Lawrenceville NJ, US-CA-San Francisco, US-NJ-Cranbury-FSP Cranbury, NJ, US-MA-Cambridge-FSP Cambridge MA, US-CA-San Diego, US-MD-Rockville, US-WI-Middleton-Middleton WI Research Way, US-FL-Ocala, US-PA-Warminster, US-IL-Round Lake-FSP Roundlake IL, US-PA-Moon Township-FSP Moon Township PA FSP Dr, US-WA-Seattle-FSP2 Seattle, US-CA-Foster City, US-IL-Round Lake, US-Colorado, US-WA-Bothell, US-Virginia, US-PA-Moon Township, US-Georgia, US-Illinois, US-FL-Ocala-Neurohealth, US-WA-Seattle-FSP Seattle WA, US-VA-Richmond, US-NJ-Princeton-Princeton, US-PA-West Point-FSP West Point PA, US-NJ-Hamilton-Hamilton NJ Quakerbridge Rd, US-NJ-Summit-FSP Summit NJ, US-NV-Las Vegas-Las Vegas NVUS-IL-North Chicago, US-CA-San Carlos, US-NJ-Pennington-FSP Hopewell NJ, US-Ohio-Cincinnati, US-AZ-Phoenix, US-TX-Austin, US-NJ-Pennington, US-NC-Wilmington, US-CA-Foster City-FSP Foster City CA, US-MA-Waltham, US-TX-Austin-Austin TX Metro Center Dr 300, US-PA-Philadelphia-FSP Philadelphia PA, US-NJ-Rahway, US-MD-Rockville-FSP Rockville MD, US-PA-Collegeville-FSP Collegeville PA, US-FL-Orlando-Orlando FL, US-KY-Highland Heights, US-MA-Boston, US-Maryland, US-MA-Devens, US-North Carolina, US-MA-Boston-FSP Boston MA, US-MD-Bethesda, US-MA-Cambridge-FSP2 Cambridge, MA, US-FL-Orlando-Orlando Compass Clinic, US-WI-Middleton, US-PA-Philadelphia-FSP Phila PA Crescent Drive, US-FL-Melbourne, US-PA-Horsham, US-IL-Chicago, US-PA-Blue Bell, US-Arizona, US-NJ-Kenilworth-FSP Kenilworth NJ, US-WA-Seattle, US-PA-King of Prussia-FSP King of Prussia PA, US-Nevada, US-NY-East Syracuse, US-Michigan, US-Michigan-Detroit, US-Washington, US-FL-The Villages-The Villages, US-District of Columbia-Washington, DC, US-New Jersey, US-NC-Morrisville, US-Minnesota, US-NJ-Princeton-FSP Lawrenceville NJ, US-CA-San Francisco, US-NJ-Cranbury-FSP Cranbury, NJ, US-MA-Cambridge-FSP Cambridge MA, US-CA-San Diego, US-MD-Rockville, US-WI-Middleton-Middleton WI Research Way, US-FL-Ocala, US-PA-Warminster, US-IL-Round Lake-FSP Roundlake IL, US-PA-Moon Township-FSP Moon Township PA FSP Dr, US-WA-Seattle-FSP2 Seattle, US-CA-Foster City, US-IL-Round Lake, US-Colorado, US-WA-Bothell, US-Virginia, US-PA-Moon Township, US-Georgia, US-Illinois, US-FL-Ocala-Neurohealth, US-WA-Seattle-FSP Seattle WA, US-VA-Richmond, US-NJ-Princeton-Princeton, US-PA-West Point-FSP West Point PA, US-NJ-Hamilton-Hamilton NJ Quakerbridge Rd, US-NJ-Summit-FSP Summit NJ, US-NV-Las Vegas-Las Vegas NVSubmission for the position: Regulatory Affairs Manager (Functional Service Partnership) - Contract Opportunity - (Job Number: 169543)