Pharma Executive Regulatory Affairs

1 day ago

Pune Maharashtra, India Humano Forte Full time

**Job Description
- Regulatory Affairs Executive**

**Position**:Regulatory Affairs Executive

**Location**:Pune, India

**Experience**:2 - 5 Years

**Market Focus**:Emerging Markets (LATAM and Middle East)

**Qualification**:B. Pharm, M. Pharm, Microbiology, or relevant degree

**Roles & Responsibilities**:

- Regulatory Documentation & Submission & Review
- Compliance & Regulatory Knowledge
- Stay updated with global regulatory guidelines and standards, including FDA, EMA, ICH, and country-specific regulations.
- Knowledge implementation of GMP compliance and QMS (Quality management system).
- Customer & Market surveillance for preparation of PMS/PSUR reports
- Database Management
- Confidentiality Agreements & Supply & Distribution Agreement review and management.
- Communication and collaboration with different strategic and other manufacturers for documentation and registration
- Registration of trademarks in India
- Co-ordination with RTM group of companies for any regulatory related work
- Finding clients for providing regulatory services & consulting
- Visit to manufacturing facilities of the strategic partners
- Preparation of artworks and printing artworks & product samples management

**Required Skills**:

- Master's degree in pharmacy, Microbiology, or a relevant field is required.
- Minimum 0 - 4 years of experience in Regulatory Affairs, with a focus on dossier preparation and product registrations in emerging markets.
- Strong understanding of regulatory requirements and submission processes for LATAM and Middle Eastern markets.
- Ability to effectively manage multiple product registrations and ensure timely approvals.
- Strategic thinker with excellent analytical and problem-solving skills.
- Proven track record of successful product registrations and dossier submissions in emerging markets.

Pay: ₹318,600.92 - ₹565,270.34 per year

Work Location: In person

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