Senior Manager, Regulatory Operations

Known for its scientific and operational excellence, Regeneron is a leading science-based biopharmaceutical company that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. Regeneron commercializes medicines for eye diseases, high LDL-cholesterol, atopic dermatitis and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including rheumatoid arthritis, asthma, pain, cancer and infectious diseases.

Summary:

Responsible for leading and managing Regulatory Operations staff who format and publish electronic documents for Regulatory submissions, and also build, submit, and, archive Regulatory submissions pertaining to multiple Regulatory Applications such as INDs and amendments, CTAs and amendments, BLAs and amendments/
supplements, MAAs and variations in accordance with applicable Regulatory Agency regulations, guidance, and/or specifications (eg, FDA, EMA, ICH, etc).

Requires minimal guidance from direct manager.

Functions as a contributor as needed.

Provides support and backup to management as needed.

Job Duties:

Leads, manages, and develops Regulatory Operations staff

Ensures timely processing and delivery of Regulatory submission deliverables to Regulatory Agencies or partners

Analyzes resource needs and secures additional resources as needed, including securing and managing vendor support

Ensures development and maintenance of Regulatory Operations standards and procedures are in accordance with all applicable Regulatory regulations, guidance, and specifications
Provides guidance to multidisciplinary teams on developing submission structure strategies in accordance with applicable Regulatory Agency regulations, guidelines, and/or specifications (eg, FDA, EMA, ICH, etc)
Identifies regulatory system enhancement needs or technical issues and works closely with systems and technical support staff to identify, develop, and implement solutions

Assists with regulatory inspection activities
Requirements:

Bachelor's Degree (preferred)
12+ Years
Requires knowledge of applicable Regulatory Agency regulations, guidelines, and specifications (eg, FDA, EMA, ICH, etc)

Requires eCTD and NeeS knowledge

Possess courage, energy and drive, strong operating skills, strong personal and interpersonal skills, and strong strategic skills
Can work independently, ability to multitask, self-motivated, well organized, detail oriented, able to prioritize, works effectively under pressure, and has excellent written and verbal communication skills.
Working knowledge of Microsoft Office suite, Adobe Acrobat, ISIToolbox and/or A-Pulse, electronic document management systems (Veeva preferred), eCTD publishing systems (eCTDManager preferred), eCTD validation and viewing tools, and XML are required. Working knowledge of eCTD authoring templates (StartingPoint) is preferred.

Will be responsible for supervising staff.

This is an opportunity to join our select team that is already leading the way in the Pharmaceutical/Biotech industry. Apply today and learn more about Regeneron's unwavering commitment to combining good science & good business.

To all agencies: Please, no phone calls or emails to any employee of Regeneron about this opening. All resumes submitted by search firms/employment agencies to any employee at Regeneron via-email, the internet or in any form and/or method will be deemed the sole property of Regeneron, unless such search firms/employment agencies were engaged by Regeneron for this position and a valid agreement with Regeneron is in place. In the event a candidate who was submitted outside of the Regeneron agency engagement process is hired, no fee or payment of any kind will be paid.

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability status, protected veteran status, or any other characteristic protected by law.