Senior Director, Regulatory Submission Management

Location
Tarrytown, NY, United States
Posted
Sep 04, 2019
Ref
16971BR
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:
Accountable for building, leading, and managing a global Regulatory Submission Management department, working through managers who are responsible for sub-departments that project manage regulatory submissions; format and publish regulatory submission documents; publish an submit regulatory submissions; and manage Regulatory information through Regulatory system business-side project management, business analytics, Regulatory systems training, and archiving; and ensure Regulatory compliance.

Responsibilities:

• Accountable for overseeing and leading first line management of a Regulatory Submission Project Management team who are responsible for staff who: perform regulatory project management tasks for regulatory submissions such as developing and maintaining submission plans; developing and managing submission timelines; coordinating and tracking documents; and reporting on document and submission status.

• Accountable for overseeing and leading first line management of a Regulatory Operations team who are responsible for staff who: ensure regulatory submission documents are properly formatted and published; ensure submissions are built per Agency specifications; provide guidance on submission build strategies to multidisciplinary teams.

• Accountable for overseeing and leading first line management of a RIM team, which includes overseeing managers and staff who are responsible for project managing business systems projects; creating, maintaining, and training on pertinent Regulatory procedural documents; supporting business needs by liaising with internal stakeholders and the Regulatory Systems team, IT, and vendors to identify technical solutions; development and training on Regulatory submission document templates; training on Regulatory Information Management (RIM) systems and tools; archiving Regulatory records pertaining to multiple Regulatory Applications such as INDs and amendments, CTAs and amendments, BLAs and amendments/supplements, MAAs and variations all in accordance with applicable Regulatory Agency regulations, guidances, and/or specifications (eg, FDA, EMA, ICH, etc); marketing Regulatory systems and tools across the organization; and managing all Regulatory information pertaining to these applications.

• Works closely with the Regulatory Systems team who are responsible for: supporting the company's ongoing regulatory initiatives by assisting in planning, implementing, integrating, and optimizing information systems needed for managing regulatory submissions worldwide.

• Ensures there are sufficient resources to support planned submissions or other projects and communicates the need for additional resources to management as needed. Guides first line managers on effective management of their resources including vendors and contractors who support submission related activities.

• Serves as the primary contact for RSM. Also serves as the primary contact with regulatory authorities for Regulatory technical matters.

• Ensures the necessary SOPs, WPs, and standards for managing regulatory submissions worldwide are established and in accordance with all applicable Regulatory regulations, guidance, and specifications, as well as, company policies and procedures.

• Leads and manages a highly successful, productive, and respected team by: identifying and hiring candidates who provide added value to our already robust and diverse talent portfolio; promoting a team environment that fosters both professional and personal growth; motivating, engaging, and empowering staff; coaching and mentoring staff through frequent and direct feedback; encouraging and supporting change; and maintaining a strategic focus that is aligned with the company's goals.

• Provides support and backup to management as needed. Provides support and backup to the RSM team as an individual contributor during peak periods.

• Leads and/or serves as a member of cross-functional committees and represents the interests of the RSM team

Requirements:

Education

• Bachelor's Degree

Experience

• 15+ 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.