This job has expired

You will need to login before you can apply for a job.

Senior Manager Regulatory Affairs

Employer
Regeneron Pharmaceuticals, Inc.
Location
Tarrytown, New York
Start date
Nov 4, 2022

View more

Discipline
Regulatory, Regulatory Affairs
Required Education
Masters Degree/MBA
Position Type
Full time
Hotbed
Pharm Country, Best Places to Work
You need to sign in or create an account to save a job.

Job Details

This position in Regulatory Affairs involves the ability to integrate/apply knowledge of global regulations governing pharmaceutical drug development to all aspects of Regeneron's quality, preclinical and clinical drug development programs, policies, and procedures, so that Development teams are able to meet all objectives within specified timelines and so that the necessary state of compliance is maintained relative to all regulatory commitments/requirements.

In this role, a typical day might include the following:

* Act as liaison between company and FDA and other health authorities for assigned programs

* Develop regulatory strategies for assigned programs in collaboration with Regeneron's Regulatory senior management and by analysis of guidance’s and assessment of drug developed for similar indication to obtain approval of activities in support of Regeneron’s development and marketing objectives within specified timelines

* Management of all regulatory activities associated with Regeneron development programs.

o Participate in multidisciplinary project teams to provide regulatory guidance and communicate regulatory goals.

o Provide guidance to multidisciplinary teams on the content, format, style and architecture of an Investigational New Drug (IND) application or CTA for ex-US/ex-EU studies. Edit or manage the editing of scientific sections of an IND application against the regulatory requirements. Assist with the writing, review and preparation of an IND application. Manage the organization, preparation and review of IND amendments, annual reports and other regulatory documents and correspondence. o Perform/manage critical analyses of data (clinical, preclinical and manufacturing), independently develop interpretations and conclusions. Perform reviews of clinical protocols and study reports to focus attention on deficient/missing items/explanations. o Accountable for ensuring the completeness and accuracy of all regulatory submissions. o Supervisory responsibility for the planning, preparation and submission of regulatory documentation.

* Management of the planning, preparation and submission process for licensing applications.

o Provide guidance/instruction to multidisciplinary teams on the content, format, style architecture and timing of a Biologics Licensing Application (BLA).

o Assist with the scientific writing and review of a BLA and evaluate conformance with the regulatory requirements.

* Continually monitor newly published FDA guidelines and international guidance documents in the context of new and ongoing development programs. Provide training on applicable requirements for scientific staff as required.

* Develop regulatory strategies for assigned programs by analysis of guidance’s and assessment of drug developed for similar indication

This role might be for you if:

  • If you bring good understanding of US FDA and international pharmaceutical guidance, regulations, drug development process, and industry standard practices.
  • If you are interacting with CROs in the management of ex-US/ex-EU CTAs towards clinical trial activations preferred
  • If you have a high attention to detail; ability to coordinate and prioritize assigned projects according to company goals
  • You bring strong interpersonal skills both written and verbally

To be considered, you must possess excellent written and verbal communication skills along with a MD, Ph.D. or Pharm D. degree. We expect a minimum of 5 years of pharmaceutical industry experience, at least 3 of which should include regulatory experience.

#GDRAJobs

Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits including health and wellness programs, fitness centers and equity awards, annual bonuses, and paid time off for eligible employees at all levels!

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.

The salary ranges provided are shown in accordance with U.S. law and apply to U.S. based positions, where the hired candidate will be located in the U.S. If you are outside the U.S, please speak with your recruiter about salaries and benefits in your location.

Salary Range (annually)

$117,700.00 - $192,100.00

Company

Regeneron is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to seven FDA-approved treatments and numerous product candidates in development, all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye disease, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, infectious diseases, pain and rare diseases.
 
Regeneron is accelerating and improving the traditional drug development process through our proprietary VelociSuite® technologies, such as VelocImmune® which produces optimized fully-human antibodies, and ambitious research initiatives such as the Regeneron Genetics Center, which is conducting one of the largest genetics sequencing efforts in the world.

Stock Symbol: REGN

Stock Exchange: NASDAQ

FacebookTwitterInstagramYouTube Logo

Find Us
Website
Phone
914-847-7000
Location
Corporate Headquarters
777 Old Saw Mill River Road
Tarrytown
New York
10591
United States
You need to sign in or create an account to save a job.

Get job alerts

Create a job alert and receive personalized job recommendations straight to your inbox.

Create alert