• Snapboard
  • Activity
  • Reports
  • Campaign
Welcome ,

Chat with the recruiter

...Minimize

Hey I'm Online! Leave me a message.
Let me know if you have any questions.

Regulatory Affairs Manager

In New Jersey / United States

Save this job

Regulatory Affairs Manager   

Click on the below icons to share this job to Linkedin, Twitter!

JOB TITLE:

Regulatory Affairs Manager

JOB TYPE:

JOB SKILLS:

JOB LOCATION:

Franklin Lakes New Jersey / United States

JOB DESCRIPTION:

Responsibilities:

  • The RPM will provide business support to GRA.
  • Assists GRT's in determining resource requirements utilizing scheduling and resource management tools to support late development teams without dedicated RPMs in R&D.
  • Creates project and portfolio level reports utilizing various systems to support decision making.
  • Will manage the regulatory end-to-end process from entry into late development through launch.
  • Will represent "Regulatory Program Management" at the GRT.
  • Translates regulatory strategy into realistic and executable regulatory deliverables with clear assumptions based on GRT input.
  • Works out regulatory scenarios to support decision making in line with Regulatory and CDT strategy.
  • Supports early risk identification and development of mitigation strategies.
  • Works in close collaboration with the Regulatory Leader (GRL) to proactively prepare regulatory activities to be discussed in the GRT.
  • Works in close collaboration with the Regulatory Liaisons and Professionals to work out NA-EMEA-APJLA specific details on Health Authority interactions and submissions.
  • Works in close collaboration with Submission Operations at timings of pre-submission activities.
  • Is single Point of Contact for "Regulatory Program Management" activities.
  • Provides cross-functional leadership to the submission teams in executing the finalized pre-submission plan, including direct management of Modules 1 and 2.
  • Proactively plans and manages the cross-functional project deliverables that support the global regulatory strategy and worldwide submissions (NA EMEA - APJLA):
  • Active follow-up on the progression of all regulatory activities required to successfully and timely complete the regulatory deliverables (Health Authorities interactions, submissions ....) Monitors regulatory driven key milestones, decision points and critical path activities.
  • Creates project related reports to support decision making at PMT, GRT and CDT level, supports regulatory portfolio oversight, supports team member planning of short- and long-term deliverables; informs stakeholders on project deliverables status. Coordinates the creation, maintenance, management and timely submission of regulatory project budgets (OOPs & FTEs).
  • Owns the Global Regulatory Affairs (GRA) schedule in V6; creation, monitoring and maintenance.
  • Represents "Regulatory Program Management" at the PMT.
  • Works in close collaboration with the CDT Program Management Leader (CDT-PML) to ensure alignment of the regulatory strategy with the CDT strategy.
  • Works in close collaboration with the PMT Program Managers to ensure alignment of functional strategies with the regulatory strategy.
  • Proactively manages the regulatory development plan (scope, time, cost).
  • Is single Point of Contact for "Regulatory Program Management" Activities.
  • Critical Competencies, Change Leadership, Interdependent Partnering, Innovation, Results Driven, Project Team Management and Development..
  • Understanding of Regulatory processes, both pre- and post-marketing.
  • Knowledge of regulations, guidelines and regulatory requirements is preferred.
  • Detailed knowledge of project planning, tracking, resource management, project planning and scheduling tools, and cross-project analyses.
  • Registration experience with global submissions or preparation of dossiers is preferred.

Requirement:

  • B.S. or advanced degree in pharmaceutical-related subject.
  • Professional project management certification is a plus.
  • Five years of relevant experience including at least 3-5 years in (bio)pharmaceutical R&D.
  • Experience in regulatory matrix organization is preferred. Project management experience in R&D drug development is a must.

Position Details

POSTED:

Jul 08, 2021

EMPLOYMENT:

INDUSTRY:

SNAPRECRUIT ID:

S16204865178763816

LOCATION:

New Jersey / United States

CITY:

Franklin Lakes

Job Origin:

CEIPAL_ORGANIC_FEED

A job sourcing event
In Dallas Fort Worth
Aug 19, 2017 9am-6pm
All job seekers welcome!

Regulatory Affairs Manager    Apply

Click on the below icons to share this job to Linkedin, Twitter!

Responsibilities:

  • The RPM will provide business support to GRA.
  • Assists GRT's in determining resource requirements utilizing scheduling and resource management tools to support late development teams without dedicated RPMs in R&D.
  • Creates project and portfolio level reports utilizing various systems to support decision making.
  • Will manage the regulatory end-to-end process from entry into late development through launch.
  • Will represent "Regulatory Program Management" at the GRT.
  • Translates regulatory strategy into realistic and executable regulatory deliverables with clear assumptions based on GRT input.
  • Works out regulatory scenarios to support decision making in line with Regulatory and CDT strategy.
  • Supports early risk identification and development of mitigation strategies.
  • Works in close collaboration with the Regulatory Leader (GRL) to proactively prepare regulatory activities to be discussed in the GRT.
  • Works in close collaboration with the Regulatory Liaisons and Professionals to work out NA-EMEA-APJLA specific details on Health Authority interactions and submissions.
  • Works in close collaboration with Submission Operations at timings of pre-submission activities.
  • Is single Point of Contact for "Regulatory Program Management" activities.
  • Provides cross-functional leadership to the submission teams in executing the finalized pre-submission plan, including direct management of Modules 1 and 2.
  • Proactively plans and manages the cross-functional project deliverables that support the global regulatory strategy and worldwide submissions (NA EMEA - APJLA):
  • Active follow-up on the progression of all regulatory activities required to successfully and timely complete the regulatory deliverables (Health Authorities interactions, submissions ....) Monitors regulatory driven key milestones, decision points and critical path activities.
  • Creates project related reports to support decision making at PMT, GRT and CDT level, supports regulatory portfolio oversight, supports team member planning of short- and long-term deliverables; informs stakeholders on project deliverables status. Coordinates the creation, maintenance, management and timely submission of regulatory project budgets (OOPs & FTEs).
  • Owns the Global Regulatory Affairs (GRA) schedule in V6; creation, monitoring and maintenance.
  • Represents "Regulatory Program Management" at the PMT.
  • Works in close collaboration with the CDT Program Management Leader (CDT-PML) to ensure alignment of the regulatory strategy with the CDT strategy.
  • Works in close collaboration with the PMT Program Managers to ensure alignment of functional strategies with the regulatory strategy.
  • Proactively manages the regulatory development plan (scope, time, cost).
  • Is single Point of Contact for "Regulatory Program Management" Activities.
  • Critical Competencies, Change Leadership, Interdependent Partnering, Innovation, Results Driven, Project Team Management and Development..
  • Understanding of Regulatory processes, both pre- and post-marketing.
  • Knowledge of regulations, guidelines and regulatory requirements is preferred.
  • Detailed knowledge of project planning, tracking, resource management, project planning and scheduling tools, and cross-project analyses.
  • Registration experience with global submissions or preparation of dossiers is preferred.

Requirement:

  • B.S. or advanced degree in pharmaceutical-related subject.
  • Professional project management certification is a plus.
  • Five years of relevant experience including at least 3-5 years in (bio)pharmaceutical R&D.
  • Experience in regulatory matrix organization is preferred. Project management experience in R&D drug development is a must.


Please wait..!!