Regulatory Submission Project Management - Specialist

Location
Tarrytown, NY
Posted
Oct 11, 2019
Ref
17362BR
Required Education
Bachelors Degree
Position Type
Full time
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 project management of regulatory submission deliverables such as INDs and CTAs and amendments, BLAs, amendments/supplements, MAAs and variations in accordance with applicable regulations, guidelines, and/or specifications (FDA, EMA, ICH, etc.).

Requires some guidance from direct manager.

Provides support and backup to management and other team members as needed.

Responsibilities:

- Creates and maintains submission plans (table of contents, timeline and responsibility matrix), and facilitates the resolution of timeline issues with regulatory and cross-functional team members

- Manages and coordinates submission documents that require reviews and Regulatory Operations processing

- Conducts kickoff, submission core team and line function meetings

- Provides guidance on good documentation and submission practices

- Provides requested submission documents to partners and CROs

- Helps maintain and track regulatory commitments

- Assists with reviewing and developing departmental procedural documents in accordance with applicable regulations and guidance

- Assists with regulatory inspection activities

- Identifies and communicates regulatory system enhancement needs or technical issues to management

Requirements:

- Bachelor's Degree

- 5+ Years

- Requires knowledge of applicable Regulatory Agency regulations, guidelines, and/or specifications (eg, FDA, EMA, ICH, etc.)

- Requires eCTD knowledge

- Project management skills required

- Working knowledge of pharmaceutical metadata (preferred)

- Can work independently (some guidance from direct manager anticipated), ability to multitask, self-motivated, well organized, detail oriented, able to prioritize, works effectively under pressure, and has excellent written and verbal communication skills.

- Strong knowledge with Microsoft Word, Adobe Acrobat, and electronic document management systems are required. Familiarity with Microsoft Project preferred.

- Provides support and backup to management as needed

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.