Principal Reg Affairs Spec

Company
PPD
Location
Cambridge, United Kingdom
Salary
Competitive
Posted
28 Aug 2019
Closes
13 Sep 2019
Ref
1156886
Discipline
Regulatory Affairs
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)
Purpose:

Global Regulatory Affairs Role which provides innovative solutions including global regulatory expertise and client interface to provide strategic regulatory intelligence, guidance and regulatory expertise for product development from preclinical through registration and product optimization. Provides regulatory advice and carries out projects in the provision of regulatory affairs services. Acts as liaison with internal and external clients in the provision and marketing of these services. Works with the Regulatory Affairs Management to perform the day to day operational aspects of the department such as: preparation and assembly of global regulatory submissions unassisted, interacting with sponsors, review and assess clinical trial regulatory documents, review and assess scientific literature.

Essential Functions and Responsibilities:

Major Responsibilities
  • May perform any or all duties at the Senior Regulatory Specialist level
  • Provides senior review of regulatory submissions
  • Mentors less experienced GRA staff to support understanding of regulations, impact on study, assessment of risk, etc
  • Performs other duties as required

Complexity

Works on problems of diverse scope where analysis of data requires evaluation of identifiable factors.

Job Knowledge

A seasoned, experienced professional with a full understanding of area of specialization; resolves a wide range of issues in creative ways. This job is the fully qualified, career-oriented, journey-level position.

Supervision

Normally receives little instruction on day-to-day work, general instructions on new assignments. Demonstrates good judgment in selecting methods and techniques for obtaining solutions.

Business Relationships

Represents the department as a prime contact on projects. Interacts with internal and external personnel on significant matters often requiring coordination between functional areas. Networks with senior internal and external personnel in own area of expertise. Occasional contact with external clients.

.

Qualifications:

Qualifications:

Education and Experience:
  • Bachelor's degree and 5+ years of experience
  • OR Equivalent combination of education, training, & industry experience

Knowledge, Skills and Abilities:
  • English language as well as local language where applicable
  • Attention to detail and quality of documentation
  • Good interpersonal skills
  • Familiar with computers and their applications, e.g. Word, Excel, Power Point
  • Effective oral and written communication skills
  • Basic organizational and planning skills
  • Good negotiation skills
  • Ability to work independently with direction
  • Proven ability to work effectively in a team environment
  • Good knowledge of global/regional/national country requirements/regulatory affairs procedures for clinical trial authorization, licensing, lifecycle management
  • Ability to handle multiple projects
  • Analytical and investigative skills
  • Ability to interpret data
  • Expert knowledge of ICH and other global regulatory guidelines
  • In-depth knoweldge of one of the specialty areas: preclinical, clinical or CMC, etc
  • Good judgement and decision-making skills Ability to act as liaison with other departments Knowledge of budgeting and forecasting


Management Role:
  • No management responsibility


Working Conditions and Environment:
  • Work is performed in an office environment with exposure to electrical office equipment.
  • Occasional drives to site locations with occasional travel both domestic and international.

Physical Requirements:
  • Frequently stationary for 6-8 hours per day.
  • Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists.
  • Frequent mobility required.
  • Occasional crouching, stooping, bending and twisting of upper body and neck.
  • Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs.
  • Ability to access and use a variety of computer software developed both in-house and off-the-shelf.
  • Ability to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences.
  • Frequently interacts with others to obtain or relate information to diverse groups.
  • Works independently with little guidance or reliance on oral or written instructions and plans work schedules to meet goals. Requires multiple periods of intense concentration.
  • Performs a wide range of variable tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence. Ability to perform under stress. Ability to multi-task.
  • Regular and consistent attendance.

Pharmaceutical Product Development, LLC is firmly committed to Equal Employment Opportunity (EEO) and prohibits employment discrimination for employees and applicants based on age, race, color, pregnancy, gender, gender identity, sexual orientation, national origin, religion, marital status, citizenship, disability or protected veteran or other status protected by federal, state, and/or local law.

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