- Company Name
- Saje Natural Wellness
- Job Title
- Regulatory Affairs Manager (12-month Contract)
- Job Description
-
**Job title:** Regulatory Affairs Manager (12‑month Contract)
**Role Summary:**
Lead the Regulatory Affairs team, guiding pre‑market approvals, post‑market compliance, and regulatory strategy across NHPs/Dietary Supplements, Cosmetics, Medical Devices, OTCs, and General Consumer Products. Manage cross‑functional collaborations, mentor staff, oversee budgets, and act as the liaison for regulatory authorities and industry associations.
**Expactations:**
- Demonstrate 7+ years of progressive Regulatory Affairs experience, including leadership of regulatory strategy and submission activities.
- Prove expertise in pre‑market authorizations, product licensure, and post‑market vigilance across multiple jurisdictions.
- Apply global regulatory knowledge to interpret changes, assess risk vs. benefit, and develop proactive solutions.
- Negotiate with regulatory bodies and industry groups; advocate for favorable regulatory positions.
- Manage team resources, budgets, and workflows effectively.
**Key Responsibilities:**
- Identify regulatory issues at product concept, submission, and documentation stages; negotiate with authorities to secure approvals.
- Oversee pre‑market authorizations, post‑market notifications, risk mitigation, and vigilance programs for a portfolio of regulated products.
- Design and refine internal review processes; advise on regulatory strategy, precedence, and regulatory climate impacts.
- Perform risk‑benefit analysis of changing regulations; create mitigation strategies for leadership approval.
- Deliver training and strategic guidance on compliance, risk awareness, and quality standards company‑wide.
- Cultivate and maintain international regulatory agency partnerships; represent the company in professional associations.
- Coordinate with legal counsel on regulatory matters.
- Administer product vigilance systems, ensure accurate incident reporting, and communicate gaps to stakeholders.
- Recruit, mentor, and develop regulatory team; manage packaging, promotional, and marketing compliance.
- Negotiate and oversee support contracts; control day‑to‑day workflow and deliverables.
- Prepare and monitor team budgets, forecasts, and expenditures to maintain financial health.
**Required Skills:**
- Strong knowledge of global regulatory frameworks (FDA, EMA, CDRH, ANVISA, PSM, etc.).
- Expertise in submissions, product licensure, and post‑market surveillance for regulated products.
- Advanced risk‑benefit assessment and proactive regulatory strategy development.
- Effective negotiation and stakeholder engagement skills.
- Leadership, coaching, and team‑management abilities.
- Budgeting, forecasting, and project‑management competency.
- Excellent communication, documentation, and training delivery.
**Required Education & Certifications:**
- Bachelor’s degree in Life Sciences, Regulatory Affairs, or related field.
- Advanced regulatory certification (e.g., Certified Regulatory Professional) preferred.