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Global Regulatory Affairs Submissions Manager

Avanir Pharmaceuticals

This is a Contract position in Aliso Viejo, CA posted June 12, 2019.

Global Regulatory Affairs Submissions ManagerThe Global Regulatory Affairs Submission Manager is accountable for handling specific responsibilities within the scope of the Regulatory Affairs Submissions Management, including contributing to the planning, preparation and review of global regulatory submissions and supporting the quality review, formatting, organization, and structuring of major regulatory submissions for his/her assigned products.

This role will manage and facilitate high quality and timely Global Health Authority submissions via communication and coordination with internal and external stakeholders.

This individual must have a keen eye for details and strong project management skills.

The incumbent will provide operational support that facilitates effective concise Global Health Authority communications in support of broader project team initiatives and corporate goals.

She/he will utilize in-depth knowledge of global regulatory submission requirements and will work collaboratively within Regulatory Affairs, Regulatory Operations, and other cross-functional departments to set goals, drive process efficiencies and overall operational effectiveness for timely and high quality global regulatory submissions.

This includes the management and development of detailed high quality global regulatory submissions, timelines, and reports as well as all tasks in order to plan submission activities and resources, and ensuring that documents and applications are prepared in compliance with Global Regulatory Health Authority regulations/guidance, Avanir’s SOPs, and meet the quality standards set forth by Avanir in the Authoring Style Guide.Essential Job FunctionEnsure high quality and timely submissions are delivered to Global Regulatory Health Authorities which are aligned to both Avanir and Health Authority standards.

Working closely with intra-departmental and cross-functional teams, he/she is an internal regulatory subject matter expert for the submission planning, preparation and review process to ensure submissions are prepared in a compliant, high-quality fashion within assigned timelines.Conduct document formatting and quality check review activities for the purposes of preparing high quality regulatory documents for global regulatory submissions.Serve as StartingPoint templates subject matter expert and trainer, providing guidance on submission related processes and content formatting requirements.Assist in the development/implementation and maintenance of document formatting standards, template user guides, checklist, processes and procedures related to formatting and QC review, and the Avanir Authoring Style Guide.

Work collaboratively with GRLs and contributing cross-functional lines in order to create and maintain global regulatory submission project plans, manage deliverable timelines and activities, ensure alignment on roles and responsibilities, and that any issues, risks, or impact due to changes in strategy and/or timelines are assessed quickly throughout the submission process ensuring transparency of submission status to key stakeholders and management.Responsible for the coordinating, drafting, and preparation of forms, cover letters and certain Module 1 components where required for submissions.

May facilitate Global Regulatory Team meetings (GRTs) providing support to respective GRLs with oversight, planning and delivery of GRT goals and global submissions.

This may include preparation of agendas, documentation of decisions, development and active management of timelines and meeting minutes.Understand, adhere to, and advise others as needed on Global Health Authority regulations and guidance associated with electronic submissions, which differ across regions.Participate in the writing of regulatory processes (SOPs, work instructions and/or internal guidelines) and other departmental initiatives to improve standards and systems internally and maintain relationships with other departments including consultants, CROs and vendors.Education/QualificationsBachelor’s degree in Business Management, Life Sciences, or related field required.

Post-graduate coursework may be desirable.7 years of experience in the pharmaceutical/biotechnology industry with knowledge of multiple aspects of the product development (CMC, nonclinical and clinical) with a minimum 5 years within Regulatory and demonstrated organizational/planning skills with submissions/project management experience.Experience with authoring templates such as StartingPoint.

Strong knowledge of Microsoft Office suite, Microsoft Project and/or other project management tools, Adobe Acrobat, Adobe Plug-Ins (e.g.

ISI Toolbox), Electronic document management systems (e.g.

Documentum, First Docs, etc.), eCTD publishing tools (e.g.

eCTDXpress), eCTD validation and viewing tools.Highly knowledgeable in CTD/eCTD structure and requirements and a solid understanding of submission requirements for submission types (e.g.

IND, CTA, NDA, MAA, DMF, PSUR, DSUR, etc.).

Strong experience and knowledge of US and other major global (ICH, EU, Asian) regulatory requirements (FDA and/or EMA, etc.)Possesses an expert understanding and working knowledge of global submission format requirements and a strong knowledge of the drug development processes, relative functional capabilities, and interdependencies.Strong attention to detail and accuracy.Demonstrated project management skills, with the ability to integrate planning efforts across departments to ensure organizational effectiveness.Excellent verbal and written communication skills.Proficiency with computer productivity programs necessary to complete work requirements (e.g., MS Word, Excel, Outlook, and PowerPoint).

Ability to work independently as well as work in a team environment with changing timelines and priorities, multi-task in a very fast-paced environment, pay close attention to detail, and follow projects through to completion to meet deadlines.

Must be able to effectively collaborate with peers and comfortable working in a matrixed team.Must be solutions oriented and pragmatic (with analytical thinking and problem solving skills).Must thrive working in a fast-paced, innovative environment while remaining flexible, proactive, resourceful and efficient.Physical Requirements:This position primarily works in an office environment.

It requires the ability to sit or stand for long periods of time and frequent walking.

Daily use of a computer, phone, office equipment and other computing and digital devices is required.

May be required to stand for extended periods when facilitating meetings or walking in the facilities.

Some local travel may be necessary, so the ability to travel by plane, operate a motor vehicle and maintain a valid Driver’s license and/or effectively navigate public transportation is required.

While performing the responsibilities of the job, the employee must be able to read and respond to interoffice communications as well as effectively participate in meetings.

The employee is often required to sit and use their hands and fingers, to lift up to 20 lbs., pull, push, carry, handle or feel.

The employee is required to carry, handle items, reach with arms and hands, to stoop, kneel, or crouch; talk or hear.

Mental demands may require prolonged concentration, reading comprehension, understanding and interpretation of concepts, ideas and philosophies.

The physical demands of the position described herein are essential functions of the job and employees must be able to successfully perform these tasks for extended periods.

Reasonable accommodations may be made for those individuals with real or perceived disabilities to perform the essential functions of the job described unless such accommodations would cause Avanir an undue burden.Work Environment:While performing the responsibilities of the job, these work environment characteristics are representative of the environment the job holder will encounter.

Reasonable accommodations may be made to enable people with disabilities to perform the essential functions of the job unless such accommodations would cause Avanir an undue burden.

While performing the duties of this job, the employee is occasionally exposed to moving carts, mechanical equipment (copiers, computers, coffee machines) and vehicles.

May be subject to smells and odors.

The noise level in the work environment is usually quiet to moderate.

The passage of employees through the work area is average and normal.EEO Statement:As an equal opportunity employer, Avanir Pharmaceuticals is committed to providing all applicants and employees with equal access to employment opportunities, regardless of sex, race, age, color, national origin, ancestry, disability, pregnancy, religion, genetic information, sexual orientation transgender status, gender identity, marital status, military or veteran status, or any other characteristic protected by federal, state, or local law.

All Avanir Pharmaceuticals employees, officers, principles, agents, and representatives are expressly prohibited from engaging in unlawful discrimination.

Consistent with federal, state, and local requirements, Avanir Pharmaceuticals will reasonably accommodate any qualified individual with a disability if such accommodation would allow the individual to perform the essential functions or the job, unless doing so would create an undue hardship.Avanir Pharmaceuticals shall abide by the requirements of 41 CFR-60-300.5(a) and 60-741.5(a).

These regulations prohibit discrimination against qualified individuals on the basis of protected veteran status or disability, and require affirmative action by covered prime contractors and subcontractors to employ and advance in employment qualified protected veterans and individuals with disabilities.Avanir Pharmaceuticals, Inc.

is a biopharmaceutical company focused on bringing innovative medicines to patients with central nervous system disorders of high unmet medical need.

As part of our commitment, we have extensively invested in our pipeline and are dedicated to advancing medicines that can substantially improve the lives of patients and their loved ones.

For more information about Avanir, please visit http://www.avanir.comAvanir is a subsidiary of Otsuka America, Inc.

(OAI), a holding company established in the U.S.

in 1989.

OAI is wholly owned by Otsuka Pharmaceutical Co., Ltd.

The Otsuka Group employs approximately 42,000 people globally, and its products are available in more than 80 countries worldwide.

Otsuka welcomes you to visit its global website at https://www.otsuka.co.jp/enAvanir® is a trademark or registered trademark of Avanir Pharmaceuticals, Inc.

in the United States and other countries