Regulatory Affairs Specialist

This role is for one of our clientsIndustry: HealthcareSeniority level: Mid-Senior levelMin Experience: 3 yearsLocation: HyderabadJobType: full-timeWe are looking for a skilled and detail-oriented

Regulatory Affairs Specialist

to support our regulatory strategy and compliance functions in the botanical and herbal healthcare domain. The ideal candidate will be responsible for preparing and managing Drug Master Files (DMF), ensuring adherence to ICH guidelines, and overseeing product registrations and approvals across domestic and global markets.This role demands a strong understanding of regulatory frameworks, excellent documentation skills, and the ability to collaborate with cross-functional teams to ensure successful submissions and compliance.

Key Responsibilities

Prepare, compile, and submit

DMFs, dossiers, and regulatory filings

for botanical and herbal healthcare products.Ensure compliance with

ICH guidelines

and Indian regulatory norms (including

CDSCO

requirements).Manage

product licensing, registrations, renewals, and variations

in domestic and international markets.Act as a liaison between regulatory authorities and internal teams to address and resolve queries.Monitor global and local regulatory changes and integrate updates into internal processes.Provide regulatory insights to

R&D, Quality Assurance, and Manufacturing teams

during product development.Maintain accurate regulatory records and ensure timely submissions.Support and coordinate

regulatory audits and inspections

.Contribute to the development and execution of

regulatory strategies

for herbal and botanical healthcare products.

Qualifications

Bachelor’s degree

in Pharmacy, Life Sciences, or a related discipline (Master’s preferred).

2–8 years of regulatory affairs experience

, preferably in botanical or herbal healthcare.Strong expertise in

DMF preparation and submission

.In-depth knowledge of

ICH guidelines (Q7, Q9, Q10, Q11)

and

Indian regulatory frameworks

(CDSCO).Proven experience managing regulatory

licensing and product registration

processes.Excellent written and verbal communication skills with strong attention to detail.Ability to work collaboratively with cross-functional teams and manage multiple priorities.

Preferred Skills

Experience with international regulatory submissions (e.g.,

US FDA, EMA, TGA, MHRA

).Familiarity with

GMP requirements

for botanical/herbal products.Understanding of

safety, efficacy, and quality documentation

specific to herbal healthcare.