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Specialist - Regulatory Affairs Job

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Date: Oct 11, 2017

Location: Plainsboro, NJ, US

Company: Novo Nordisk

Requisition ID 50042BR
Title Specialist - Regulatory Affairs
Job Category Regulatory
Job Description Purpose

Provide proactive support and technical assistance to more experienced regulatory personnel. Identify issues and inform appropriate individuals. Ability to work with less supervision than Associate. Take initiative to assist with overflow in other areas as needed.

Relationships

Reports to a Manager, Sr. Manager, Associate Director or Director. Works with personnel in other departments including Marketing, CMR, Legal, and counterparts in NNAS Regulatory Affairs. Has a positive approach to work projects and maintains constructive and positive interactions with colleagues.

Essential Functions:

THERAPEUTIC AREA:
* Assist Manager/Director in review of labeling for marketed products and new products as assigned.
* Maintain up-to-date knowledge of data requirements and formats, applicable current SOPs, regulations, and guidelines, and proactively provides guidance to ROI staff as needed during assembly of regulatory submissions.
* Draft more complex correspondence.
* Draft ROCs for more complex contacts.
* Prepare routine correspondence.
* Provide proactive support and technical assistance during preparation and review of regulatory documents.
* As assigned, participate in project teams.
* Assist with technical preparation for FDA meetings, including review of draft questions and supporting documents.
* Assume additional responsibilities as applicable.
* Complete internet searches.
* Proactively manage the scope of project responsibilities, identify and compose draft correspondence relevant to projects on own initiative, such as letters of response, transmittal and memoranda where applicable. Use and contribute to development of templated correspondence as appropriate, ensuring that all new information is correct.
* Proactively seek and find information/potential answers to challenging areas related to assigned projects in the interest of keeping the project streamlined and moving forward.
* Provide proactive support in managing project.
* Take the initiative to assist with overflow in other areas as needed.
* Advise stakeholders of submission completion.
* Compile applications and prepare for sign-off (INDs/NDAs/BLAs/510ks, IND amendments & Annual Progress Reports, NDA Annual Reports & Annual ADE Reports, IND Safety Reports, Drug & Establishment Listings, responses to FDA communications, among others as assigned), assure submission to government agencies in support of investigational and marketed products is completed in accordance with supervisor’s requirements and guidance.
* Coordinate review of documents and follows up to resolve issues.
* Obtain documents/information for regulatory submissions from various functional areas and checks for errors, missing information, legibility, translations, etc.
* Proactively coordinate document submission.
* Proactively identify issues and inform appropriate individuals.
* Review information from local & NNAS contributing departments and provide comments to assure that documents are accurate and complete and comply with FDA regulations.
* Works with manager to gather internal intelligence including tracking and maintaining the Submissions Plan update. Consolidates research and gathers Novo Nordisk opinions/position (e.g. FDA draft guidances, proposed rules). Works with manager to compose letters incorporating NN position on external regulatory initiatives.
* Works with Group Manager to maintain surveillance of regulatory environment and competitor development.
* Evaluates submission information for input into Regulatory Information Management System (RIMS) within required timelines.
* Responsible for maintenance reports notification for all projects/products Quarterly and Annual Safety Updates. Works with Labeling group to ensure timely completion of labeling tasks and assignments.
* Participates in department forum meetings e.g. CMC, PRB, and ensures that proper minutes from these meetings are available in the database. Assists with overflow in other areas as needed and handle other duties and/or special projects as assigned by Regulatory Management.
Physical Requirements:
* 0-10% overnight travel required
Qualifications:
* A Bachelor's Degree required; Life Science preferred.
* A minimum of 5 years experience required (Pharmaceutical industry, laboratory, or clinical research experience).
* An intermediate to advanced proficiency in Microsoft Office Suite required.
* Attention to detail and skill in reviewing to ensure accuracy.
* Effective personal time management and project management skills.
* Excellent written, verbal and listening communication skills.
* Focuses on streamlining of processes to add value.
* The ability to work with less direct supervision than at Associate level.
* Willingness and ability to identify and implement action plans independently.

Department CMR - REG AFFAIRS (3)
Position Location US - Plainsboro, NJ
City Plainsboro
State/Provinces US - NJ

At Novo Nordisk, we know that driving change on a global level and improving treatment outcomes for people with diabetes and other chronic diseases begins here at home. That's why we make an unmatched commitment to our employees, our families and our communities. That means outstanding rewards, industry-leading training programs, and an environment that supports you to achieve your goals at every level. It's all part of the Novo Nordisk Way. It includes our Vision and our commitment to the Triple Bottom Line principle – helping us find the right balance between compassion and competitiveness

With a career at Novo Nordisk, you’ll feel a difference right from the start. It’s a sense of inspiration and mobility that comes from a shared belief in driving positive change for people, families, and communities everywhere. Congratulations on taking your first step!

Novo Nordisk is committed to equal employment opportunity and providing reasonable accommodations to applicants with physical and/or mental disabilities. We value and encourage diversity and solicit applications from all qualified applicants without regard to race, color, gender, sex, age, religion, creed, national origin, ancestry, citizenship, marital status, physical or mental disability, medical condition, veteran status, genetic information, or any other characteristic protected by federal, state, or local law.

Novo Nordisk will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information.

If you are interested in applying for employment with Novo Nordisk and need special assistance or an accommodation to use our website or to apply for a position, please call the U.S. Toll Free number at 1-855-411-5290 or click on the following link to submit your request: https://www.surveymonkey.com/r/novoaccommodation. Please note we do not accept applications for employment or employment related solicitations through this site. If you are requesting special assistance, please specify your request by selecting "Yes" in Question 2 on the site. We will not be able to respond to requests unless you specify the need for special assistance or an accommodation in Question 2. Determinations on requests for reasonable accommodation are made on a case-by-case basis.


Nearest Major Market: New Jersey

Job Segment: Regulatory Affairs, Medical, Law, Special Medicine, Pharmaceutical, Legal, Healthcare, Science

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