Key Points for Quick Understanding:
- Role: Team Member – Regulatory Respiratory
- Location: Vikhroli, Maharashtra, India
- Division: IPD (International Product Development)
- Employment Type: Permanent
- Primary Responsibility: Managing the life cycle of respiratory products by preparing, reviewing, and submitting regulatory documents.
- Experience Required: 6 years in regulatory filing for respiratory products in US, EU, or international markets.
- Educational Requirement: Bachelor’s/Master’s in Pharmacy
- Skills: Collaboration, Innovation, Accountability, Agility, Leadership, Strong Domain Knowledge, and People Management.
Join Our Team as a Regulatory Respiratory Specialist
Are you a detail-oriented professional with a passion for respiratory product development and regulatory affairs? Alembic Pharmaceuticals is seeking a Team Member – Regulatory Respiratory at our Vikhroli, Maharashtra location. This is a pivotal role in our International Product Development (IPD) division, aimed at managing regulatory filings and ensuring the successful launch and lifecycle management of respiratory products across global markets.
What You’ll Do:
As a key member of our team, you will be responsible for preparing, reviewing, modifying, and submitting documents related to the registration of respiratory products. Your focus will be on maintaining the product lifecycle, ensuring compliance with regulatory standards, and supporting product launches across markets like the US, EU, and other international regions.
You’ll play a crucial role in gathering data, compiling regulatory dossiers, responding to deficiencies, and ensuring timely approvals for our products. Additionally, you will coordinate cross-functionally with other teams, such as product development and marketing, to ensure products launch on schedule. You will also manage post-approval lifecycle activities, including site transfers and regulatory updates, ensuring our products remain compliant and competitive in the market.
Key Accountabilities:
- Strategic Insight: You will conduct region-specific regulatory gap analyses for registered dossiers and create tailored submission strategies for each market. By leveraging these strategies, you will guide our product development teams in aligning with regulatory requirements.
- Dossier Management: As a regulatory expert, you’ll be in charge of compiling detailed dossiers for respiratory products. You will review and organize all relevant documentation to ensure successful submission and approval in international markets. Handling deficiency responses will be key to achieving timely product launches.
- Lifecycle Management: Post-approval, you will ensure smooth lifecycle management of our products by submitting regulatory packages for any required changes or updates. This includes working on initiatives like site transfers, keeping the regulatory database updated, and contributing to our ongoing commercial success.
- Global Regulatory Database: Another significant aspect of your role is maintaining an updated global registration database for respiratory products, ensuring all information is accurate and accessible.
- Cross-functional Collaboration: You will actively participate in various meetings, such as Control Tower, SAP, CIPDOX, and GOOSE, representing the respiratory team. This ensures that you are always in sync with the broader organizational goals and initiatives.
The Perfect Candidate:
This role requires 6 years of experience in regulatory filing, submission, and approval, particularly for respiratory products. A solid understanding of drug product development is crucial. You’ll need a Bachelor’s or Master’s degree in Pharmacy, with a deep knowledge of regulatory requirements in markets like the US, EU, and other global regions.
In addition to technical expertise, we value certain core competencies that will help you succeed in this role:
- Collaboration: You’ll need to work closely with multiple teams to ensure deadlines are met and regulatory requirements are fulfilled.
- Innovation: Creative problem-solving and the ability to adapt to changing regulatory landscapes will set you apart.
- Accountability: Taking ownership of your tasks and being responsible for the timely submission and approval of dossiers is essential.
- Leadership and Empathy: Leading with empathy is crucial for managing relationships, whether it’s within your team or with external stakeholders.
- Agility: In a fast-paced, regulatory environment, the ability to quickly adapt to new challenges is critical.
Why Join Us?
Alembic Pharmaceuticals offers a vibrant, growth-focused environment where innovation and regulatory excellence are at the heart of our work. You’ll have the opportunity to work on exciting respiratory products that impact global markets while playing a crucial role in their development and commercialization.
If you’re ready to be part of a team that thrives on collaboration and innovation, and if you have the skills to excel in a regulatory environment, we encourage you to apply for this dynamic role today!
