Connecting...

Associate Director, Regulatory Strategy

  • Job type Contract
  • Salary competitive
  • Location Cambridge, Massachusetts
  • Sector Pharma & Biotech

OBJECTIVES:

Regulatory Strategy Objectives::

* Responsible for regulatory activities supporting the development of vaccine candidates

* Manages regulatory projects and submissions for vaccine candidates

* Ensures that all necessary applications are filed and maintained in compliance with applicable regulations.

* Provides regulatory oversight for assigned projects, focused on non-clinical and clinical, and CMC aspects of drug development and associated regulations.

* Leads and directs the work of others as part of a matrixedorganization

* Collaborates with all regulatory counterparts to ensure a global regulatory alignment for all projects within area of responsibility

* Provides global CMC regulatory program support to vaccine programs in various stages of development.

ACCOUNTABILITIES:

* Co-ordinates and is accountable for all Health Authority submissions and approvals within area of responsibility. Has a quality focus so that submissions are right-first-time.

* Coordinates interactions with and submissions to FDA. Communicates effectively the outcome of Health Authority interactions and provides analyses of potential impact.

* Ensures compliance with both internal company process and policy and with regional regulatory requirements all with a focus on quality and accuracy in verbal and written communication.

* Act as US regulatory content and procedural subject matter expert to internal stakeholders on matters related to regulatory affairs activities in the US and Canada. Provides a regulatory strategic focus on all aspects of drug development and associated regulations.

* Accountable for overall content and management of local regulatory components and filings i.e. BLAs, INDs . Contribute to overall strategy and content for local label development.

* Responsible for assigned project/timeline planning and tracking of commitments. Responsible for communication of commitments to team members.

* Actively participate as member of Global Regulatory Teams supporting products.

* Responsible for US specific documentation supporting development and maintenance of products and ensuring filings meet local regulatory requirements.

* Manages health authority meeting preparation as applicable for specified projects.

* Prepares and manages regulatory submissions for assigned vaccines in various phases of development.

* Supports regulatory compliance assessment with respect to filing requirements for assigned vaccines throughout development.

* Defines CMC content (data and documentation) requirements for regulatory submissions and compiles/reviews this content for conformance with established requirements

* Ensures project team colleagues, line management, and key stakeholders are apprised of risks that may impact regulatory success, exercising sound judgement and communicating in a professional and timely manner.

* Evaluates change controls for regulatory impact and filing requirements. *Develops and maintains constructive relations with key internal and external colleagues, e.g. cross functional colleagues within the company

EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS:

* BS, advanced scientific degree preferred.

* A minimum of 7years of pharmaceutical industry experience. This is inclusive of 5 years of regulatory experience or combination of 10 years regulatory and/or related experience in the vaccine area. * Vaccines and/or biologics experience is preferred..

* Preferred experience in managing multiple filings resulting in first-time approval; or managing multiple programs in closely related development area.

* Relies on extensive experience and judgment to plan and accomplish goals.

* Understands and interprets complex scientific issues across projects and area(s) of responsibility as the issues relate to regulatory requirements and strategy.

* Generally strong in all basic skills sets such as oral and written communications, managing and adhering to timelines, negotiation skills, integrity and adaptability.

* Exceptionally strong in the following areas: working well with others including on cross-functional teams and communication with leadership

Sthree US is acting as an Employment Business in relation to this vacancy.