Executive International Regulatory Affairs

**Executive: International Regulatory Affairs & Product Management**

**Key Responsibilities for International Regulatory Affairs**
- **Global Regulatory Strategy Development**:

- Determine pathways for product approvals in different markets (e.g., EMA in Europe, South East Aisa, Latum, USA, etc.)
- Understand varying regulatory landscapes and requirements.
- **Product Registration & Dossier Preparation for different countries**:

- Compile and submit documents such as CTDs (Common Technical Documents) or DMFs (Drug Master Files).
- Tailor submissions based on different distributor requirements.
- Multi regional dossier management.
- Align product registration dossiers with region-specific formats
- **Communication with Regulatory Authorities**:

- Serve as a liaison with agencies like FDA, EMA, TGA, etc.
- Respond to queries, manage audits, and attend meetings.
- **Monitoring Regulatory Changes**:

- Stay updated on changes in legislation and guidelines globally.
- Advise internal teams to ensure ongoing compliance.

5. Regulatory Strategy for Market Entry
- Advise on optimal regulatory pathways for early market access or accelerated approvals (e.g., FDA Fast Track, EU PRIME).
- Conduct gap analysis to understand additional testing or studies required for foreign markets.
- **Labelling and Packaging Compliance**:

- Ensure that labels meet language, safety, and legal standards for each market.
- **Lifecycle Management**:

- Handle post-approval changes, renewals, variations, and market surveillance.

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8. Coordination with Global Functions
- Collaborate with international Quality, R&D, Legal, Marketing, and Supply Chain teams.
- Align global product development with regulatory expectations.

9. Cross-Border Liaison & Negotiation
- Interact with regulatory consultants, in-country agents, or affiliates to support local submissions.
- Address agency questions, deficiency letters, or inspection findings globally.
- Cross functional collaboration
- Collaborating with different team for the preparation of dossier and regulatory documents.

11. Navigating Country-Specific Regulations
- Understand cultural and regulatory nuances that may impact approval timelines.

8. Import/Export Regulatory Support
- Ensure customs documentation and regulatory certificates (e.g., CoPP, FSC) meet import/export requirements.
- Liaise with authorities for export licensing, tariffs, and trade compliance.

**Key Skills Required**:

- Knowledge of international regulations (ICH, US FDA, EU MDR, etc.)
- Strong documentation and communication skills
- Ability to manage cross-border and cross-functional teams
- Multilingual capabilities (a plus, not always required)

**Key responsibilities for Product Management**

**1. Product Strategy & Vision**
- Define the product vision, mission, and long-term roadmap.
- Align the product strategy with company objectives and market trends.

**2. Product Development Oversight**
- Work closely with development teams during design, build, and testing phases.
- Participate in Agile ceremonies like sprint planning, backlog grooming, and reviews.

**3. Market Research & Customer Insights**
- Conduct market analysis, competitor benchmarking, and user research.
- Identify customer pain points and validate market needs.

**4. Product Roadmapping & Planning**
- Develop and maintain a product roadmap with clear priorities and timelines.
- Balance short-term delivery and long-term innovation.

**5. Performance Measurement**
- Define KPIs and success metrics (e.g., adoption rate, NPS, churn, revenue).
- Use data to make informed product decisions and report to stakeholders.

**6. Product Lifecycle Management**
- Manage the entire lifecycle: concept → launch → growth → maturity → sunset.
- Plan for feature retirements, product updates, or end-of-life (EOL) strategies.

**7. Cross-Functional Collaboration**
- Act as the liaison between engineering, design, marketing, sales, support, and leadership.
- Ensure all teams are aligned on product goals and progress.

**8. Regulatory & Compliance Awareness**:

- In regulated industries, ensure the product complies with relevant regulations.
eligibility criteria, B Pharma, M Pharma, or any science Graduate
kindly contact-7069788866

**Job Types**: Full-time, Permanent

Pay: ₹20,000.00 - ₹30,000.00 per month

Work Location: In person