Job Detail

Senior Submission Manager Global Regulatory Operations

Req ID: 17215
Job Category: Regulatory Affairs

Location: Zurich, Zurich

Posting Date: December 20, 2019

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Senior Submission Manager, Global Regulatory Operations

Location: Zürich, Switzerland, or Dublin, Ireland

Position Summary

The Senior Submission Manager is accountable for managing the major and non-routine submission activities for Alexion’s portfolio. The Senior Submissions Manager designs and executes high quality global submission plans, ensuring Alexion delivers compliant submissions to global health authorities within required timeframes. The Senior Submission Manager provides technical expertise to cross-functional submission project teams, to promote and bring excellence in planning, preparation and delivery of regulatory submissions. He/She will act as the primary point of contact for project and/or submission teams when significant planning effort and oversight is required. The Senior Submission Manager will also assist the Submission Operations Lead in activities related to setting standards, best practices, KPIs collection, developing new procedures and work instructions, and lessons learned dissemination and will assist in other activities as needed. It is also expected that he/she will be involved in publishing and archiving activities and mentoring junior members of the group. Oversees and monitors the overall archiving activities in the GRO Group.

Principal Responsibilities

• Provides operational oversight for the planning, preparation, publishing, validation and timely submission of assigned applications (IND, BLA, MAA, etc.), updates, amendments, and variations to global regulatory agencies.


• Monitors the development of new regulatory requirements or guidances, and provides advice to Global Regulatory Operations and product teams of the impact on the business.


• Contributes to development and implementation of standards for dossier management, publishing, archiving and submission process for global regulatory authorities


• Participates in selection and implementation of electronic Regulatory Document Management systems (including Part 11 compliance);


• Responsible for ensuring compliant and timely archiving of all regulatory submissions and correspondences for Alexion products


• Assists the Submission Operations Lead in assessing impact of standards and requirements with a regional impact to existing and new systems.


• Involved in regulatory submission process improvements activities and establishing repeatable processes utilizing key technologies, tools and processes


• Assists leadership in advising company on optimal submission strategy. Assists in actively engaging external and internal initiatives


• Works with GRO leadership to oversee strategic implementation of outsourcing services, when needed


• Ensures SOP adherence, application of best practices, oversight of contractors and CROs, and customer/stakeholder interactions, and overall vendor management activities.


• Oversees the activities related to obtaining CPPs and other similar certificates


• Responsible for management of the cross-functional global submission teams in the delivery of compliant submission components according to agreed standards, requirements, timelines and processes. This includes planning and presenting at project ‘kick-off’ meetings and preparing appropriate materials to facilitate team discussion, timeline mapping and submission strategy.


• Participates and shares lessons learned sessions to encourage process improvement and efficiencies within and across submission project teams.


• Negotiates and agrees on realistic dates for document handoffs in collaboration with the authors and publishers.


• In collaboration with the regulatory lead, manages the development and maintenance of a global submission content map, which includes a detailed list of all source submission content (documents, data, etc.) and tracks documents from authoring to approval and publishing.


• As a global submissions expert, ensures the project team has sufficient awareness and knowledge of e-submissions (eCTD, NeeS, etc.) and lifecycle management concepts and communicates regional differences as appropriate within the context of global submission preparation.

Qualifications

• A minimum of 7 years of experience in regulatory affairs/operations within the pharmaceutical industry.


• Strong verbal and written communication and presentation skills. A superb training skill is a plus.


• Strong interpersonal skills and ability to work effectively and build relationships with cross-functional teams.


• Self-motivated and results-oriented with high energy drive to mentor junior members of the group


• Highly knowledgeable in CTD/eCTD structure and requirements and a solid understanding of submission requirements for global submission types (e.g. IND, BLA, MAA, NDS, CTA, PSUR etc.).


• Solid experience in publishing and compilation of eCTD submissions for US and EU filings is required and experience publishing electronic submissions in other regions is desirable.


• Expert knowledge of Microsoft Office suite, Adobe Acrobat, Adobe Plug-Ins (e.g. ISIToolbox), electronic document management systems, eCTD publishing tools, eCTD validation and viewing tools. Solid experience and knowledge of SharePoint technology is desired.


• In-depth knowledge of StartingPoint templates or similar.


• Demonstrated project management, organizational and planning skills.


• Ability to multi-task, pay close attention to detail, and follow projects through to completion to meet deadlines.


• Ability to work independently (with minimal supervision), as well as work in a team environment with changing timelines and priorities.


• Must be able to adhere to strict project timelines and budgets, and to advise teams and management of impacts and changes in project time-lines.


• Solid understanding of submission deliverable dependencies and ability to reflect this in project plan in order to create and maintain detailed submission schedules (as MS-Project tasks).


• In-depth understanding of the internal and external interdependencies among submission activities that could have an impact on the schedule or quality of a submission and manage to ensure that submission goals are met on a timely manner and to the highest quality.


• Experience with core dossier concepts and global document reusability is essential.


• Prior publishing and archiving experience is a must.

Education

• A minimum of a Bachelor’s degree in a scientific or technical discipline is required; equivalent experience may be accepted. Advanced degree in a scientific discipline preferred.


• A minimum of 6 years pharmaceutical or other related industry experience with 3+ years of direct regulatory operations and submission management experience

Zurich, Switzerland
 

Some opportunities happen only once in a lifetime – like a job where you have the extraordinary opportunity to change lives. At Alexion, such opportunities arise through our unwavering mission to serve patients and families affected by rare diseases. These patients are our guiding star, and we act with integrity, urgency, and discipline because we know their lives are at stake.

Alexion is a global biopharmaceutical company focused on serving patients and families affected by rare diseases through the discovery, development and commercialization of life-changing therapies. As the global leader in complement biology and inhibition for more than 20 years, Alexion has developed and commercializes two approved complement inhibitors to treat patients with paroxysmal nocturnal hemoglobinuria (PNH) as well as the first and only approved complement inhibitor to treat atypical hemolytic uremic syndrome (aHUS), anti-acetylcholine receptor (AchR) antibody-positive generalized myasthenia gravis (gMG) and neuromyelitis optica spectrum disorder (NMOSD). Alexion also has two highly innovative enzyme replacement therapies for patients with life-threatening and ultra-rare metabolic disorders, hypophosphatasia (HPP) and lysosomal acid lipase deficiency (LAL-D). In addition, the company is developing several mid-to-late-stage therapies, including a second complement inhibitor, a copper-binding agent for Wilson disease and an anti-neonatal Fc receptor (FcRn) antibody for rare Immunoglobulin G (IgG)-mediated diseases as well as several early-stage therapies, including one for light chain (AL) amyloidosis and a second anti-FcRn therapy. Alexion focuses its research efforts on novel molecules and targets in the complement cascade and its development efforts on the core therapeutic areas of hematology, nephrology, neurology, and metabolic disorders. Alexion has been named to the Forbes’ list of the World’s Most Innovative Companies seven years in a row and is headquartered in Boston, Massachusetts’ Innovation District. The company also has offices around the globe and serves patients in more than 50 countries. Further information about Alexion can be found at: www.alexion.com.

As a leading employer in our industry, Alexion is proud to offer a highly competitive package of base and incentive compensation as well as a comprehensive benefits program designed to support the health, wellness and financial security of our employees and their families. Benefits include group medical, vision and dental coverage, group and supplemental life insurance, 401(k) with company match, tuition reimbursement, relocation assistance and much more.