Associate Regional Submission Lead

The Associate Regional Submission Lead (aRSL) will manage the Clinical Trial Information system E2E for assigned CTAs in close collaboration with (EU) RSL to meet the strategic and operational goals in the region in accordance with the associated quality standards. The position is responsible for Submission deliverables and performance in assigned CTAs covering all therapeutic areas.

**Primary activities/responsibilities**
- Study Registration and internal tracking of registered studies
- Manage internal company systems and ensure compliance as per agreed regulatory requirements
- Facilitate Supply Release process for EU countries
- Manage CTIS for CTA lifecycle (original CTAs, Modifications, triage of RFIs, serious breaches, inspections, ad hoc assessments, CTA notifications management, aCSR and transparency, and Full CSR (until MAA is obtained)
- Investigator Initiated study support for company owned drug products (collaboration with Investigators) as well as for joint Ventures (collaboration with other Pharmaceutical companies)
- Facilitate document collection from countries and overall admin support in close
- collaboration with Senior RSL
- Collaborate with RCPM Directors across regions to share best practices.
- Provide guidance to project management teams in developing regional processes and tools.

**Core competencies**:

- Expertise of core clinical systems, tools and metrics
- Excellent English skills
- Strong coordination and organizational skills
- Ability to make decisions independently with oversight from RSL or
- manager
- Requires strong understanding of European Regulatory framework
- Ability to proactively develop risk management and mitigation plans in the
- region

**Behavioral Competency Expectations**:

- Problem solving is essential
- Requires the ability to pro-actively identify issues and risks, analyze root cause, and propose solutions to problems and escalate to management as applicable.
- Strong communication, leadership, and negotiation skills as well as excellent influencing
- Ability to focus on multiple deliverables and protocols simultaneously is essential. Requires that the individual has ability to work effectively also in a remote virtual environment with a wide range of people.

**Experience Requirements**:

- 5 years of experience in clinical research or Regulatory environment
- Bachelor's Degree in Business Finance/ Administration/ Life Science or equivalent Health Care related experience

**Secondary** Language(s) Job Description**:
**Core competencies**:

- Expertise of core clinical systems, tools and metrics
- Excellent English skills
- Strong coordination and organizational skills
- Ability to make decisions independently with oversight from RSL or

manager
- Requires strong understanding of European Regulatory framework
- Ability to proactively develop risk management and mitigation plans in the

region
**Behavioural Competency Expectations**:

- Problem solving is essential
- Requires the ability to pro-actively identify issues and risks, analyse root cause, and propose solutions to problems and escalate to management as applicable.
- Strong communication, leadership, and negotiation skills as well as excellent influencing
- Ability to focus on multiple deliverables and protocols simultaneously is essential. Requires that the individual has ability to work effectively also in a remote virtual environment with a wide range of people.

**Experience Requirements**:
5 years of experience in clinical research or Regulatory environment
**Educational Requirements**:
Bachelor's Degree in Business Finance/ Administration/ Life Science or equivalent Health Care related experience

**Search Firm Representatives Please Read Carefully**

**Employee Status**:
Regular

**Relocation**:
**VISA Sponsorship**:
**Travel Requirements**:
**Flexible Work Arrangements**:
Remote

**Shift**:
**Valid Driving License**:
**Hazardous Material(s)**:
**Job Posting End Date**:
11/23/2024

**Requisition ID**:R316826