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Senior Specialist in Regulatory Affairs Management
2 months ago
As a Senior Specialist in Regulatory Affairs Management at Cynet Systems, you will play a pivotal role in navigating the complex landscape of regulatory compliance. Your expertise will be essential in ensuring that our products meet the necessary standards and regulations.
Key Responsibilities:
- Deliver timely and relevant regulatory insights to support internal teams.
- Communicate effectively about critical business issues to facilitate informed decision-making, collaborating with subject matter experts to evaluate impacts on product lines and strategic objectives.
- Lead and coordinate internal teams in crafting responses to proposed legislation, regulatory guidelines, and policy issues.
- Engage closely with colleagues in R&D and External Affairs to align regulatory input with broader policy initiatives.
- Manage communications and interactions with trade associations and health authorities regarding regulatory matters.
- Champion proactive advocacy in key regulatory policy areas.
- Consult with internal leadership to pinpoint priority regulatory issues.
- Work collaboratively with stakeholders to align company policy positions and identify engagement opportunities with regulatory bodies and trade associations.
- Support regulatory policy initiatives within the Regulatory Science and Policy team.
- Thrive in a matrix environment, adeptly navigating ambiguity to drive cross-team decision-making.
- Collaborate with regulatory leads on strategic and tactical product matters, including policy issues and FDA interactions.
- Ensure successful execution of innovative consumer-focused products and manage the lifecycle of products across various regulatory categories, including OTC monograph drugs, dietary supplements, cosmetics, foods, and medical devices.
Qualifications:
- Bachelor's degree required; advanced degrees such as M.S., Pharm D, MD, or PhD preferred.
- A minimum of 3 years of experience in Regulatory Affairs.
- Proven regulatory expertise.
- Strong collaborative skills.
- Understanding of the drug/biologic development and commercialization processes.
- Exceptional time management and organizational abilities.
- Capacity to lead multiple complex projects across short, mid, and long-term timelines.
- Self-driven, action-oriented, and results-focused.
- Ability to foster an engaging and motivating work environment.