Principal Regulatory Affairs Specialist

  • Company:
    PPD
  • Location:
  • Salary:
    negotiable / month
  • Job type:
    Full-Time
  • Posted:
    17 hours ago
  • Category:
    General

Purpose:

Provides innovative solutions including global regulatory therapeutic area expertise and client interface to provide strategic regulatory intelligence, guidance and regulatory expertise for product development from preclinical through registration and product optimization with primary focus in Phase I-III Clinical Trial applications as well as supporting local AUS Licences, local intelligence duties, and as a Global Clinical Trials Regulatory Affairs Lead.

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.

*Major Responsibilities: *

* May perform any or all duties at the Senior Regulatory Specialist level

* Provides senior review of regulatory submissions

* Mentors less experienced RA staff to support understanding of regulations, impact on study, assessment of risk, etc

* Performs other duties as required

*Qualifications:*

*Education and Experience:*

* Bachelor’s degree and 5 years of experience

* OR Equivalent combination of education, training, & 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

**Job:** **Regulatory Affairs*

**Organization:** **PPD*

**Title:** *Principal Regulatory Affairs Specialist*

**Location:** *AU-AU-Melbourne-Melbourne AU Queens Road*

**Requisition ID:** *168978*

PPD is an affirmative action employer that values diversity as a strength fosters and environment of mutual respect. PPD provides equal employment opportunities without regard to age, race, color, pregnancy, national origin, religion, sex, gender identity, sexual orientation, disability, veteran status or other status within any other protected group