Contract Senior Manager, Global Regulatory Strategy

Senior Manager, Global Regulatory Strategy

20hrs a week

Remote

5-6 Months with possible extension

The Position :

Contributes to clinical and nonclinical regulatory strategic discussion, supports multiple products registrations and acts as the regulatory affairs lead for clinical trial activities for multiple programs. Contributes to the development of fit for purpose high quality documentation (e.g., INDs, CTAs, NDAs, reports, and correspondences) to support global Health Authority interactions. May oversee activities of junior regulatory personnel. Builds / maintains relationships globally and cross-functionally to ensure effective communication & efficient implementation of regulatory activities for assigned programs. Applies and further develops knowledge of assigned market regulatory procedures.

Primary Responsibilities Include :

Principle Duties and Responsibilities

Acts as the regulatory affairs lead for clinical trial activities for multiple programs, including but not limited to CTA submissions, response to agency queries, IP release, label review, etc.

Contributes to developing fit for purpose regulatory strategies for assigned projects and programs that incorporate the totality of development (clinical, nonclinical, and CMC) while accurately interpreting and reflecting regulatory and Corporate guidelines

Coordinates the preparation and submission of documents to appropriate regulatory agencies for assigned projects and programs to implement regulatory strategy in line with corporate goals

Ensures documentation management and record keeping are compliant with regulatory expectations and Client SOPs

Required to support preparation for inspection readiness

Maintains / further develops knowledge of relevant evolving regulation and guidance

Global Regulatory Teams contributor to establish and implement regulatory strategy

Works closely with RA CRO to oversee maintenance of trial progression and compliance

Impact and Scope

Works on issues where analysis of situations or data requires a knowledge of organizational objectives and current business trends

Establishes and assures adherence to budgets, schedules, work plans, and performance requirements

Works on objectives that have major impact on functional area and the organization

Erroneous decisions may result in critical delay(s) in schedules and / or unit operations and may jeopardize overall business activities.

Desired Education and Skills :

Skills and Competencies

Experience working in GRTs and cross functional teams

Knowledge of drug development, ICH guidelines and regulatory process

Experience of IND / CTA, IMPDs, Orphan drug designation, Agency Advice

Demonstrated experience with and a clear understanding of submission content and format requirements

Ability to successfully manage projects / timelines, organize / track complex information & prioritize, by communicating with internal and external stakeholders

Adaptive communication skills (including interpersonal, written, verbal) and able to influence others without authority

Solid sense of accountability and sound judgement; highest ethical standards and focus on quality and details

Ability to evaluate and recommend process improvement and suggest / implement best practices.

Proficiency with Microsoft Office Applications; Word, Excel, Outlook, Adobe, and regulatory systems (Veeva).

Education and Experience

BS or equivalent with 8+ years relevant experience