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Global Regulatory Lead
Biogen | Cambridge, Massachusetts
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Job Description

External Posting TitleGlobal Regulatory Lead
Job DescriptionPosition Summary:

As Global Regulatory Lead, responsible for developing and delivering innovative, breakthrough global regulatory strategies for product development and approval, in alignment with the global business strategy. Responsible for leading a comprehensive and strategic approach to developing and executing integrated global regulatory strategies that account for the complex interplay between major Health Authorities. Represent the company with domestic and international regulatory authorities, contractors and corporate partners. Provide regulatory support for various departments, projects, and teams/committees. May manage direct reports.

II.Duties and Responsibilities:

A. Essential Functions:

•Responsible for directing global regulatory strategies for assigned projects and programs.

•Direct global clinical and pre-clinical regulatory strategies.

•Direct global life cycle management of products.

•Support development of the late stage clinical development plan.

•Identify and assess regulatory risks associated with product development. Define strategies to mitigate risks.

•Provide regulatory guidance to company personnel throughout the research and development process.

•Set strategic direction and leads global regulatory submission process with submission teams, including marketing applications and core briefing packages.

•Develop and maintain the Core Data Sheet and lead global labeling team meetings.

•Advise on global CTA submission strategy.

•Direct the organization and preparation of clear and effective submissions.

•Prepare and deliver effective presentations for external and internal audience.

•Monitor and analyze appropriate regulatory agency activities in areas of interest to the company. Assess impact on programs.

•Mentor Regulatory Strategists and guide direct reports in carrying out responsibilities. Responsible for coordinating activities and career development of direct reports.

•Build and maintain excellent relationships with relevant regulatory agencies, contractors and corporate partners while negotiating company position.

•Provide leadership on project teams and subcommittees in all areas of regulatory affairs and product development.

•Provide input to Regulatory Senior Management teams.

•Maintain a global view as part of the whole regulatory team.

B. Additional Functions:

•Take steps to actively improve interdepartmental communications.

•Actively participate in and contribute to outside relevant conferences, including organizing and delivering presentations.

•May have presence on external regulatory committees/trade associations.
LocationCambridge, MA, US
Job CategoryRegulatory
Requisition Number31788BR
QualificationsA. Essential:

•8 years pharmaceutical/biotechnology industry experience with technical management experience.

•Minimum of 6 years in RA.

•Comprehensive knowledge of applicable regulations.

•Experience in interpretation of regulations, guidelines, policy statements, etc.

•Experience and knowledge in the preparation of major regulatory submissions and supportive amendments or supplements.

•Extensive experience working on products in development specifically relating to clinical and pre-clinical regulatory aspects of the project.

•Solid knowledge of GCPs and GLPs.

•Direct experience in interfacing with relevant regulatory authorities.

•Foster effective, positive interactions with regulatory agencies, and corporate partners.

•Ability to lead and influence project teams, committees, etc. to attain group goals.

•Demonstrate excellent leadership and communication skills.

•Ability to represent the department in project teams, committees and external meetings.

•Demonstrate strong organizational skills, including the ability to prioritize personal workload.

•Strong interpersonal skills and the ability to deal effectively with a variety of senior personnel including medical, scientific, and manufacturing staff.

•Strong sensitivity for a multicultural/multinational environment. Experience leading multi-disciplinary teams.

•Well organized, detail oriented, effective written and oral communication skills.

•Supervisory/mentoring experience.

•Ability to guide, train, supervise and prioritize workload of direct reports if applicable.

•Computer literate.

B. Preferred/Additional:

•Graduate degree preferred.

•Some international regulatory experience preferred.
•BA/BS/University degree required, Life/Health Sciences preferred.
About BiogenCorporate Overview

Through cutting-edge science and medicine, Biogen discovers, develops and delivers worldwide innovative therapies for people living with serious neurological and neurodegenerative diseases. Biogen is a pioneer in biotechnology and today the Company has the leading portfolio of medicines to treat multiple sclerosis (MS), has introduced the first and only approved treatment for spinal muscular atrophy, and is at the forefront of neurology research for conditions including Alzheimer's disease, Parkinson's disease and amyotrophic lateral sclerosis (ALS). Biogen also manufactures and commercializes biosimilars of advanced biologics. Our global organization of nearly 7,000 employees is committed to a single mission: making a meaningful difference in the lives of patients with few or no treatment options.

One of the pioneers in biotechnology, Biogen was founded in 1978 and today serves patients in nearly 90 countries. Our global headquarters and R&D operations are located in Cambridge, Massachusetts, with an international headquarters in Zug, Switzerland, world-class manufacturing facilities in Research Triangle Park, North Carolina, USA and Hillerod, Denmark, and affiliate locations around the world.

Our Science

We aspire to have the greatest impact on patients and science of any biotechnology company in the history of our industry. To us, that means creating novel medicines that benefit individuals and society, and bringing new scientific understanding to diseases for which there are no adequate treatments.

For nearly two decades Biogen has led in the research and development of new therapies to treat MS, including the most prescribed oral treatment in the world. Now our research is driving revolutionary new MS treatments with the goal of reversing or even repairing damage caused by the disease. We are now applying our neurological expertise to solve some of most challenging and complex diseases of the brain, including Alzheimer's disease, Parkinson's disease, and ALS. As we uncover new insights into human biology, Biogen is employing cutting-edge technologies to discover potential treatments for rare and genetic disorders.

Biogen is revolutionizing biologics manufacturing, developing the industry's most advanced plants and processes. This expertise is used to produce both original innovative therapies and biosimilars that expand patient access to lower-cost medicines.

Our Corporate Citizenship

The same intellectual discipline and passion that drives our science is reflected in our corporate citizenship, environmental sustainability, and commitment to diversity and inclusion. As a company, we are focused on improving science education and limiting the impact of our company on the environment. In 2015, we became a carbon neutral company and ranked first place on Newsweek's 2015 Green Rankings, and we are an industry leader on the Dow Jones Sustainability World Index. Biogen was named to Science's list of Top Employers of 2015 and in 2017 received a perfect score of 100 for the fourth consecutive year on the Human Rights Campaign (HRC) Corporate Equality Index, which also named Biogen as one of its Best Places to Work.

All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E-Verify Employer in the United States.

Please be advised that all legitimate correspondence from a Biogen employee will come from "@biogen.com" email accounts.

About Biogen

Biogen Idec Inc. is engaged in the development, manufacturing, and commercialization of therapies. The Company's products address diseases such as multiple sclerosis, lymphoma and rheumatoid arthritis. The Company has four products: AVONEX (interferon beta-1a), RITUXAN (rituximab), TYSABRI (natalizumab) and FUMADERM (dimethylfumarate and monoethylfumarate salts). AVONEX is used in the treatment of relapsing forms of multiple sclerosis (MS). RITUXAN is used in the treatment of relapsed or refractory low-grade or follicular, CD20-positive, and B-cell, non-Hodgkin's lymphomas (B-cell NHLs). TYSABRI is approved for the treatment of relapsing forms of MS. FUMADERM acts as an immunomudulator. It also has product candidates, such as BG-12 (acquired with the purchase of Fumapharm), ANTI-CD80 antibody/(galiximab), ANTI-CD23 antibody/(lumiliximab), Ocrelizumab/(Humanized ANTI-CD20 Antibody) and Lixivaptan.In January 2007, the Company completed the acquisition of Syntonix Pharmaceuticals, Inc. (Source: 10-K)

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