Talentmatics
Website:
talent-matics.com
Company:
https://www.linkedin.com/company/talent-matics
Seniority: Associate
Industries: Manufacturing
Job details:
We are looking for a Regulatory Affairs & Product Stewardship professional with strong expertise in U.S. FDA OTC regulations, chemical compliance, and techno-regulatory documentation.
Key Responsibilities:
- Manage U.S. FDA OTC drug compliance, registration, drug listing, NDC and labeling requirements.
- Review OTC labeling, claims, monographs and regulatory pathways.
- Handle US TSCA, MoCRA, GHS, HAZCOM, WHMIS, Prop 65 and other chemical compliances.
- Prepare/review SDS, hazard labels, regulatory dossiers and product documentation.
- Support FDA inspections, audits, CAPA and regulatory risk management.
- Manage regulatory requirements across USA, Canada & LATAM.
- Drive product stewardship, certifications and global regulatory compliance.
- Work closely with R&D, QA, Manufacturing, Supply Chain, customers, consultants and regulatory authorities.
- Role involves regular travel to factories, customers, industry events and regulatory stakeholders.
Ideal Profile:
- M.Sc./Ph.D. in Organic Chemistry, Analytical Chemistry, Pharmaceutical Sciences, Regulatory Affairs, Chemistry or Life Sciences.
- 5–10+ years of relevant regulatory/techno-regulatory experience.
- Strong hands-on exposure to U.S. FDA OTC compliance is preferred.
- Excellent technical documentation, communication and stakeholder management skills.
- Strong passion for chemistry, regulations, problem-solving and desktop technical work.
- Willingness to take on a long-term role with extensive stakeholder engagement and travel.
Click on Apply to know more.