15 Aug
|
Talentmatics
|
Navi Mumbai
15 Aug
Talentmatics
Navi Mumbai
We are looking for a
Regulatory Affairs & Product Stewardship qualified
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
.
📌 Regulatory Affairs (Navi Mumbai)
🏢 Talentmatics
📍 Navi Mumbai