Senior Manager, Regulatory Affairs US & Canada Strategy Lead, Therapeutic Neuroscience - Hybrid

BioSpace · North Chicago, IL · Today

LegalFull-time

About the Role

The Senior Manager, Regulatory Affairs US & Canada Strategy Lead is responsible for the development and implementation of US and Canada regulatory strategic and tactical planning (RSTP) for assigned on market products or those products in development. The Senior Manager assures that regulatory strategies defined within the GRPT are effectively implemented and maintained in line with changing regulatory and business needs. This individual identifies and gathers data needed to support filings, responses to inquiries, and registration maintenance to enable commercialization of products that are developed, manufactured or distributed to meet relevant US and Canada regulatory requirements.

Responsibilities

Responsible for a product(s) or products with multiple driver indications within a Therapeutic Area and supports manager and/or Global Regulatory Lead (GRL) in the development & execution of the regulatory strategy. Assigned matters may have a moderate impact on business activities and operations.
Serves as Health Authority (HA) liaison and interfaces with FDA for meetings, teleconferences and coordinates preparation and completion of FDA meeting briefing packages and responses.
Advise internal customers who may contribute to regulated communication on Regulatory/FDA issues including Public Affairs, Clinical Development, Legal, and others such as Commercial.
Functions independently in negotiation and decision-making for project related issues that have cross-functional impact.
May assist in the training of junior staff members.
Key contributor responsible for the preparation and review of regulatory submissions consistent within US and Canada regulatory requirements and guidelines and assures complete and timely response to Health Authorities during application review.
Supports the regulatory submission and approval process. Broadly applies regulatory/technical knowledge of government regulations and skills across therapeutic areas.
Recommends and implements changes to difficult projects based on knowledge and expertise, accurate interpretation of US and Canada government regulations, guidances, as well as corporate policies and management-related considerations.
Presents pertinent regulatory information to appropriate cross-functional areas.
Operates in compliance with regulations, company policies, procedures, and guidance in alignment with regulatory product strategy and the Quality Dossier Program (QDP).

Qualifications

Advanced degree (e.g. PharmD, PhD, MS) or Regulatory certification with minimum 5 years Regulatory, R&D, or equivalent industry-related experience.
Preferred: Advanced Degree and/or Certifications or direct experience with pharmaceutical regulatory activities
Demonstrates excellent negotiation skills, problem solving skills and builds consensus.
Demonstrates effective communication skills in written and oral channels both within Regulatory and across the organization. Able to deliver challenging messages effectively without compromising important business relationships.
Proven skill at implementing successful affiliate regulatory strategies (US or Canada experience preferred).
Experience working in a complex and matrix environment.
Experience interfacing with government regulatory agencies.
Global regulatory experience is a plus.

Pay & Benefits

Compensation range based on job grade and factors including geographic location (may be modified in the future)
Comprehensive benefits package including paid time off (vacation, holidays, sick), medical/dental/vision insurance, and 401(k) to eligible employees
Eligible to participate in long-term incentive programs

Work Environment