Associate Director - Regulatory Program Manager

Location Beerse
Discipline: Biotechnology
Job type: Temporary/Freelance
Contact name: Aimee Brenner

Contact email: a.brenner@panda-int.com
Job ref: 12282
Published: 28 days ago

I am urgently looking for an experienced Associate Director, Regulatory Program Manager to join a leading Biotech in Belgium (remote) to function as a regulatory submission leader driving projects forward through the translation of regulatory and compound strategy to executable plans and coordination of cross-functional team efforts

This role requires somebody who can offer a solid regulatory background and project management skills and experience. You are accountable to both the Global Regulatory Leader and PMO leadership for planning, executing, controlling, and reporting the functional regulatory pathway. Providing operational and program management leadership to therapeutic product and platform development programs from approximately phase 2B until all major submissions are completed.

Key Responsibilities:

· Lead operations with Global Regulatory Team, including management of worldwide submissions, pre and post-submission activities, preparations for health authority meetings

· Translate regulatory requirements and strategy into an executable plan, proactively identify and mitigate risks

· Driving project management of the submission team by setting direction, establishing team R&Rs, developing detailed submission plans

· Ensure coordination of critical GRT information and team communications to ensure timely and accurate dissemination of the GRT strategy and operational status throughout the team and between co-development partners and/or other external partners, as required.

· Serve as primary PMO point of contact to ensure GRT/CDT functional plans are aligned with compound/program objectives and commitments.

· Ensure the development and tracking of key messages and indication specific submission content maximizing the use of the Global Regulatory Strategy Plan and ensuring alignment with overall compound strategy.

· Drive process improvements and embed best practices from across programs, TA’s and functions into supported teams.

· As required, work with standard budgeting and forecasting process and reporting tools to build and maintain the regulatory components and health authority budget to an overall coordinated project plan in Planisware.
 

Qualifications

Must

- A minimum of a Bachelor’s degree

- A minimum of 5 years of industry/business experience, including a minimum of three years in pharmaceutical R&D or comparable R&D sector.

- Experience in strategic planning, development of regulatory strategy, and cross functional management of global regulatory submissions and processes (e.g. NDA, MAA, and lifecycle documents)

- Leadership and management of global submission teams in a matrixed setting, with demonstrated ability to drive and expedite team decision making and translate strategy to clear, executable action plan.

- Demonstrated experience conducting business process, scenario, and critical path analysis.

- Demonstrated understanding of Global Regulatory Affairs processes

- Proficiency in the application of project management standards, planning and visualization tools (MSP experience highly preferred).

- Proficient in written and spoken English

- Minimal local travel between sites

- Ability to work virtually

Preferred

- Post-graduate degree in life sciences, business management, regulatory affairs or related field

- Regulatory certification (RAC)

- Experience with clinical trial conduct, Phase I-Phase III.

 

START DATE

  • ASAP - 1 June 2021

DURATION

  • Until 12 December 2021

Interested?
 

If you are interested in the above description, apply with your CV

PS: Did you also know that we offer an attractive referral scheme?

For further information, please contact Aimee Brenner at +31 (0)20 20 44 502 or by email at a.brenner@panda-int.com

I am urgently looking for an experienced Associate Director, Regulatory Program Manager to join a leading Biopharma in Belgium (remote) to function as a regulatory submission leader driving projects forward through the translation of regulatory and compound strategy to executable plans and coordination of cross-functional team efforts

This role requires somebody who can offer a solid regulatory background and project management skills and experience. You are accountable to both the Global Regulatory Leader and PMO leadership for planning, executing, controlling, and reporting the functional regulatory pathway. Providing operational and program management leadership to therapeutic product and platform development programs from approximately phase 2B until all major submissions are completed.

Key Responsibilities:

· Lead operations with Global Regulatory Team, including management of worldwide submissions, pre and post-submission activities, preparations for health authority meetings

· Translate regulatory requirements and strategy into an executable plan, proactively identify and mitigate risks

· Driving project management of the submission team by setting direction, establishing team R&Rs, developing detailed submission plans

· Ensure coordination of critical GRT information and team communications to ensure timely and accurate dissemination of the GRT strategy and operational status throughout the team and between co-development partners and/or other external partners, as required.

· Serve as primary PMO point of contact to ensure GRT/CDT functional plans are aligned with compound/program objectives and commitments.

· Ensure the development and tracking of key messages and indication specific submission content maximizing the use of the Global Regulatory Strategy Plan and ensuring alignment with overall compound strategy.

· Drive process improvements and embed best practices from across programs, TA’s and functions into supported teams.

· As required, work with standard budgeting and forecasting process and reporting tools to build and maintain the regulatory components and health authority budget to an overall coordinated project plan in Planisware.
 

Qualifications

Must

- A minimum of a Bachelor’s degree

- A minimum of 5 years of industry/business experience, including a minimum of three years in pharmaceutical R&D or comparable R&D sector.

- Experience in strategic planning, development of regulatory strategy, and cross functional management of global regulatory submissions and processes (e.g. NDA, MAA, and lifecycle documents)

- Leadership and management of global submission teams in a matrixed setting, with demonstrated ability to drive and expedite team decision making and translate strategy to clear, executable action plan.

- Demonstrated experience conducting business process, scenario, and critical path analysis.

- Demonstrated understanding of Global Regulatory Affairs processes

- Proficiency in the application of project management standards, planning and visualization tools (MSP experience highly preferred).

- Proficient in written and spoken English

- Minimal local travel between sites

- Ability to work virtually

Preferred

- Post-graduate degree in life sciences, business management, regulatory affairs or related field

- Regulatory certification (RAC)

- Experience with clinical trial conduct, Phase I-Phase III.

 

START DATE

  • ASAP - 1 June 2021

DURATION

  • Until 12 December 2021

Interested?
 

If you are interested in the above description, apply with your CV

PS: Did you also know that we offer an attractive referral scheme?

For further information, please contact Aimee Brenner at +31 (0)20 20 44 502 or by email at a.brenner@panda-int.com