Senior Manager, Regulatory Affairs

Position Summary: 

Responsible for the regulatory operational objectives supporting the development of NCEs globally.  Works collaboratively with the Clinical Operations teams, CMC, Biostatistics.  Oversees and directs regulatory activities, in collaboration with the VP, Regulatory Affairs, for new and developing products to ensure alignment and compliance with local and regional registration requirements as well as company policies.  Provides guidance to the clinical, preclinical, etc. teams to ensure regulatory requirements are being met for various submissions and plans.  Develops and implements strategies, along with the respective teams, for timely submission and approval of all submission strategies, preclinical submissions applications for clinical trials and marketing applications, etc.  Ensures timely preparation of organized and scientifically valid applications. 

Essential Duties and Responsibilities:

• Implements the global Regulatory strategy for Research and Development programs; works collaboratively with the VP, Regulatory Affairs in developing strategy
• Oversee and track Regulatory activities including review of clinical documents for regulatory submissions
• Establishes operational objectives and submission strategies for various regulatory submissions, US and ex-US
• Input to clinical development strategy and plans to achieve Company objectives regarding the timing and execution of the Company’s clinical development programs
• Actively participates as a member of Project Teams supporting products
• Under the supervision of the VP, RA, responsible for the overall content and management of regulatory components and filings (INDs, NDA/BLAs, CTAs)
• Responsible for US and ex-US specific documentation supporting development and maintenance of products and ensuring filings meet local regulatory requirements
• In alignment with VP, Regulatory Affairs, oversees and is responsible for meeting the assigned project/timeline planning and tracking of commitments. Responsible for communication of commitments to team members.
• Assists in the preparation of documents, rehearsals, etc. for the Company at Regulatory Body meetings
• Works closely and collaboratively with all functions to ensure integration into the overall strategy for products under development, including CROs.
• Collaborate with R&D, Project Management, Toxicology, Research & Drug Discovery, and Legal departments to ensure Regulatory strategies and activities are aligned with corporate objectives.
• Under the direction of the VP, Regulatory Affairs, assists in the implementation of strategic plans and objectives for the organization in alignment with corporate strategy; responsible for the implementation of tactical administrative or operational activities to ensure achievement of objectives.

This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change with notice.

Required Education and Experience:

• B.S. or B.A. degree required, with advanced degree in a pharmaceutical or scientific field desired.
• A minimum of 5 years of pharmaceutical industry experience including 2-3 years of regulatory
• Solid understanding of drug development  

Required Knowledge, Skills, Abilities & Behaviors:

• Good understanding of the FDA and EMA regulated drug development process.
• Demonstrated ability to work both independently and as part of a multidisciplinary team to contribute to the preparation of high-quality submissions on time.
• Previous experience with regulatory submissions.
• Strong verbal and written communication skills.
• Detail oriented with good organizational skills.
• Working knowledge of Microsoft Word, Excel and suite of applications

Work Conditions:

• This job operated in a professional office environment.
• This role routinely uses standard office equipment such as computers, phones and photocopiers.
• This position is required to work occasional nights and weekends to meet company demands.

Physical Demands:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

Occasional travel is required via automobile, train, bus and/or airplane.

While performing the duties of this job, the employee is occasionally required to stand; walk; use hands to finger, handle, feel or operate objects, tools or controls; and reach with hands and arms. The employee is occasionally required to sit; climb or balance; stoop, kneel, crouch or crawl; talk or hear; and smell.

The employee must occasionally lift and/or move objects up to 10 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and the ability to adjust focus.

All your information will be kept confidential according to EEO guidelines.