Regulatory Affairs Associate

Industry

Pharmaceuticals

Advert ID

USA_470660

Location

Collegeville

Job Type

Contract

Hours

Full-Time

Salary Range

USD18-19/hr

No. of Openings

1

Branch Information

Manpower CORE 100 Manpower Place , WI 53212

Branch Phone Number

414-982-1960

Job Description

Manpower is currently looking for a Regulatory Affairs Associate in Groton, CT or Collegeville, PA



Pay Rate is $18hr



Job Summary

As a Project coordinator you will prepare, review, and submit documents for global product approvals. These documents include Investigational Device Exemption applications, Premarket Approval applications, Technical Files, amendments, and appropriate follow-up responses and reports. This position works with program teams to identify regulatory requirements early in the new product development process delivered to multiple Boards of Health.



To be successful within the role it is expected that you will



* Participate in ensuring a global regulatory team approach

* Work with colleagues from multiple regions in order to deliver documentation that meets the national and technical (such as but not limited to eCTD, NeES and Paper) requirements for which the submission for each region assigned (Asia Pacific, Australia/New Zealand, Africa - Middle East, Europe, East Europe, Latin America and United States)

* Proactively enters and maintains critical regulatory information relating to assigned submissions within required systems and to required standards and timelines.

* Delivers electronic and paper regulatory submissions through co-ordination and execution per standard industry practice

* Assists with interpretation of regulatory technical guidelines

* Participate in interactions with regulatory agencies on defined matter



Qualifications

* Minimum of Bachelors degree required

* Experienced in managing in a matrix environment and Regulatory Affairs

* Strong client interaction

* Technically adept using IT systems and software

* General understanding of Healthcare regulatory environment

* Fast learner with proven ability to adapt