Regulatory Affairs Specialist

This role is for one of our clients

Industry : Healthcare

Seniority level : Mid-Senior level

Min Experience : 3 years

Location : Hyderabad

JobType : full-time

We 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.

Skills Required

Regulatory Affairs