Senior Manager, Global Regulatory Affairs Operations, Submission Management

At Genmab, we’re committed to building extra[not]ordinary futures together, by developing antibody products and pioneering, knock-your-socks-off therapies that change the lives of patients and the future of cancer treatment and serious diseases. From our people who are caring, candid, and impact-driven to our business, which is innovative and rooted in science, we believe that being proudly unique, determined to be our best, and authentic is essential to fulfilling our purpose.

The Role

The Regulatory Submission Manager is responsible for managing all submissions for IND and BLA applications.  This will include working with functional teams of various disciplines to ensure compliant documents and adhering to timelines for document deliverables.  This person needs to have strong communication skills, ability to lead, and understand submission requirements.

Responsibilities

• Responsible for providing submission managing for MAAs, BLAs and INDs application.

• Responsible for interfacing with project managers, regulatory leaders, and/or content authors to discuss planned submission preparation.  Represent Regulatory Operations on project teams, driving timelines and deliverables related to submission documents.

• Liaise with functional source areas (Clinical, Nonclinical, CMC) to ensure documents are compliant and submission ready. Work with regulatory document authors to achieve resolution and ensure that documents comply with regulatory and company guidance/template specifications.

• Identifies regulatory risks and emerging issues and proactively develops mitigations and solutions.

• Ensures that all regulatory content and information is appropriately tracked, archived, searchable, and accessible via Document Management System.

• Maintain working knowledge of the regulations and processes that govern the content and maintenance of controlled documents required by the Health Authorities and ICH.

• Adherence to required submission timelines, health authority publishing specifications, and internal working practices.

Requirements                                                                                     

• BA/BS degree or equivalent, at least 6 years pharmaceutical industry experience, and prior Regulatory Operations experience required.

• Knowledge of IND and BLA requirements and guidelines.

• Proficiency with MS-Office Suite and Adobe Acrobat application.

• Knowledge of health authority procedures/guidance's regarding submissions.

• Knowledge of Electronic Document Management Systems. (Veeva)

• Ability to balance multiple tasks to meet priorities and timelines.

• Self-starter with superior time management skills, and ability to work independently or in teams.

• Strong attention to detail.

• Ability to be proactive, enthusiastic and goal orientated

• A team player with demonstrated ability to collaborate with a diverse group of internal and external stakeholders (e.g. Scientists, Trial Managers, Data Managers, Clinicians, vendors labs) to support product development strategy

• Strong communication skills - both oral and written

For US based candidates, the proposed salary band for this position is as follows: