Job Details

Senior Manager Regulatory Affairs - CNS/Pain

Company name
Regeneron Pharmaceuticals, Inc.

Location
Basking Ridge, NJ, United States

Employment Type
Full-Time

Industry
Pharmaceutical

Posted on
Nov 22, 2022

Valid Through
Mar 07, 2023

Apply for this job






Profile

The Sr. Manager, Regulatory Affairs will report to the Global Regulatory Liaison (GRL) and provides support to the GRL in all aspects of regulatory affairs related to the development of novel therapeutics including quality, preclinical and clinical areas of drug development and the policies/procedures required to ensure compliance with regulations.

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

Coordinate the preparation, submission, management and maintenance of global regulatory submissions related to clinical and nonclinical aspects of product development, including, but not limited to, the following: INDs/CTAs, amendments and information requests, Orphan drug applications, Annual Reports and Investigator’s Brochure

Assist in coordination and preparation for Agency meetings and associated briefing document preparation

Manages and tracks queries and commitments with regulatory agencies, collaborates with subject matter experts to provide written responses to queries, provides periodic status updates regarding conditions/commitments

Provide representation for study-level regulatory activities and participate in cross-functional departmental team projects and product development activities/meetings

Perform research to support the development of regulatory strategy for the assigned clinical development program

Maintains knowledge of regulatory requirements up to current date, comments on draft regulatory guidance, and communicates changes in regulatory information as needed

Exercise discretion and independent judgment in the performance of the duties described above

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 #LI-Hyrbid

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)

$131,900.00 - $215,100.00

Company info

Regeneron Pharmaceuticals, Inc.
Website : http://www.regeneron.com/

Similar Jobs:
Job Description\n\nIn BARDS (Biostatistics and Research Decision Sciences), a distinguished department within our company's renowned Research and Development division, quantitative scientists, in partnership with other subject mat...
QA Validation Specialist
Location : Millburn, NJ
339781BR QA Validation Specialist AAA Statement Advanced Accelerator Applications, a Novartis company, is an innovative medicines company focused on the development of products for targeted radioligand therapy and precisi...
ROLE SUMMARY The Global WRD Controlled Substance Lead is the central point of contact for Pfizer's R&D Sites globally. Monitor and maintain a high level of compliance of controlled substances regulatory requirements across sites ...
EmploymentCrossing was helpful in getting me a job. Interview calls started flowing in from day one and I got my dream offer soon after.
Jeremy E - Greenville, NC
  • All we do is research jobs.
  • Our team of researchers, programmers, and analysts find you jobs from over 1,000 career pages and other sources
  • Our members get more interviews and jobs than people who use "public job boards"
Shoot for the moon. Even if you miss it, you will land among the stars.
EmploymentCrossing - #1 Job Aggregation and Private Job-Opening Research Service — The Most Quality Jobs Anywhere
EmploymentCrossing is the first job consolidation service in the employment industry to seek to include every job that exists in the world.
Copyright © 2022 EmploymentCrossing - All rights reserved. 21 192