Regulatory Affairs Specialist Project Lead I - Katalyst Healthcares & Life Sciences

Dallas, TX 75001

Responsibilities :

Accountable for supporting regulatory policy efforts within the Regulatory Science and Policy team.
Will be at ease working in a matrix environment and be able to navigate ambiguity to drive decision-making working across teams.

Work with regulatory leads through cross-functional team support on both strategic and tactical product issues & opportunities including matters related to policy, product/project strategy, FDA engagement, and other external engagement efforts.
Ensure effective execution for new innovative consumer-centric products and the life cycle management of products in the portfolio across the following regulatory classes (OTC monograph drugs, dietary supplements, cosmetics, foods, and medical devices).

Monitor emerging regulatory policy issues, including issues arising from North American regulatory authorities, legislatures, within the pharmaceutical industry or elsewhere, and identify those issues likely to impact Client R&D pipeline, regulatory strategy or product portfolio.
Provide relevant ad hoc regulatory intelligence to internal stakeholders. Effectively communicate impact and bring awareness of business-critical issues for informed decision making, and work with subject matter experts within the company to assess impact on Client products and goals.
Coordinate and lead internal teams to develop Client responses and comments on draft legislation, regulations, guidelines and regulatory policies issues.
Liaise closely with colleagues (R&D, External Affairs, etc.) leading policy activities in the external environment to facilitate regulatory input and overall alignment on Client position.
Plan and manage interactions and communications with trade associations and health authorities on regulatory policy matters.
Lead proactive advocacy efforts for Client priority regulatory policy areas. Consult with internal experts and leadership to identify priority issues.
In collaboration with internal experts and stakeholders, coordinate company policy positions across stakeholder groups, identify or create opportunities for engagement with regulatory authorities and trade associations, and execute on proposed strategies.

Requirements:

Minimum B.S.: M.S., Pharm D, MD, PhD or equivalent preferred.
6 years of related experience in a pharma regulatory-related role open all therapeutic areas (not manufacturing), non-CClient experience.
MS Office - Excel, PowerPoint.
Established regulatory experience and Effective collaboration.
Familiarity and understanding of the drug/biologic development and commercialization process.
Superior time management and organizational skills.
Self-motivated, prone to action and results oriented. Provides an engaging and motivating work environment.

Ability to lead multiple complex initiatives (short, mid and long-term).
Writing, analyzing data, write-ups of research/ searches, previous experience commenting on FDA guidance documents.

Source : Katalyst Healthcares & Life Sciences