Senior Manager, Regulatory Information Management, Business Analytics

Location
Tarrytown, NY, United States
Posted
Feb 08, 2019
Ref
15229BR
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 ensuring RIM business processes and regulatory systems support submission activities such as INDs, IND amendments, BLAs, BLA supplements, MAAs, MAA variations and/or CTAs in accordance with applicable Regulatory Agency regulations, guidelines, 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:

Essential Functions required for the job. List both technical and managerial requirements if applicable.

Supports and/or leads development of procedure documents and best practices for RIM

Supports the business by establishing RIM-related business cases, user requirements, and assists with implementing new or upgrading existing RIM-related systems

Provides leadership and subject matter expertise on RIM-related projects

Supports and/or leads development of procedure documents and best practices for RIM

Supports the business by establishing RIM-related business cases, user requirements, and assists with implementing new or upgrading existing RIM-related systems

Provides leadership and subject matter expertise on RIM-related projects

Liaises with system and service vendors

Monitors, tracks, and analyses new functionality (inclusive of enhancement requests) with each new release of Regulatory systems

Collaborates with the Global Development Systems team and cross-functional key stakeholders

Assists with developing RFIs and/or RFPs for systems projects

Assist with Regulatory system solution identification

Communicates key RIM-related information to consumers, collects feedback, and takes action

Monitors and analyzes new requirements/guidance and industry RIM-related system trends, and communicates the impact

Assists with system validation activities by developing and executing test scripts for systems that support RIM-related processes

Assists with developing, implementing, and managing Regulatory information governance to ensure standard and quality data

Assists with audit and inspection activities including retrieval of RIM-Regulatory information

Requirements:

• Knowledge of applicable Regulatory Agency regulations, guidelines, and/or specifications (eg, FDA, EMA, ICH, eCTD, IDMP, UDI, etc).

• Knowledge of pharmaceutical drug and device development processes.

• Experience in Regulatory Affairs, Regulatory Business Analytics, and/or Regulatory Operations.

• Thorough knowledge and practical experience in global submissions and principles of information systems.

• Knowledge of scientific industry terminology and how to effectively use as metadata.

• Strong knowlage of categorization and classifying information.

• Expert knowledge of relationships between key components of Regulatory Information.

• Experience managing technology projects (e.g. RIM, EDMS, tracking systems, etc.)

• Ability to lead, manage, and/or contribute to multiple ongoing projects simultaneously

• Ability to lead, manage, and/or contribute to improvement initiatives

• Strong knowledge of technical writing is preferred

• Training or public speaking experience preferred

• Change management experience preferred

• Ability to engage and influence a variety of stakeholders at all organizational levels required

• Can work independently, ability to multitask, self-motivated, well organized, detail oriented, able to prioritize and manage time well, works effectively under pressure, has strong critical thinking skills, and has excellent written and verbal communication skills.

• Working knowledge of RIM solutions, electronic document management systems (Veeva Vault preferred), eCTD publishing systems (eCTDManager preferred), eCTD validation and viewing tools, XML, Microsoft Office suite, and Adobe Acrobat are required.

• Possess courage, energy and drive, strong operating skills, strong personal and interpersonal skills, strong critical thinking, and strong strategic skills

• Will be responsible for supervising staff.

Minimum Years of Experience:
14+ years

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.