Regulatory Affairs Specialist Project Lead - Katalyst Healthcares & Life Sciences
San Diego, CA 22434
About the Job
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 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 products and goals.
- Coordinate and lead internal teams to develop 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 position.
- Plan and manage interactions and communications with trade associations and health authorities on regulatory policy matters.
- Lead proactive advocacy efforts for 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.
- Minimum B.S, M.S., Pharm D, MD, PhD or equivalent preferred.
- Minimum 3 years in Regulatory Affairs.
- Established regulatory experience.
- Effective collaboration.
- Familiarity and understanding of the drug/biologic development and commercialization process.
- Excellent written, oral, and presentation communication skills; Excellent command of English (written and spoken).
- Superior time management and organizational skills.
- Ability to lead multiple complex initiatives (short, mid and long-term).
- Self-motivated, prone to action and results oriented. Provides an engaging and motivating work environment.
Source : Katalyst Healthcares & Life Sciences
