Head Regulatory Affairs

Roles & Responsibilities:

Regulatory Strategy and Leadership

1. Lead the development and execution of global regulatory strategies for formulation-based pharmaceutical products, focusing on EU and ROW markets.

2. Provide strategic direction and leadership to the regulatory affairs team, fostering a culture of excellence and compliance.

3. Stay abreast of evolving regulatory landscapes, guidelines, and requirements in various international markets.

4. Represent the company in interactions with health authorities and regulatory agencies, building strong relationships and advocating for the company's interests.

5. Oversee the preparation and review of regulatory documents, ensuring accuracy, completeness, and compliance with applicable regulations.

6. Provide guidance on regulatory requirements for product development, manufacturing, and commercialization.

Dossier Preparation and Submissions

1. Implement and maintain robust document management systems to ensure efficient tracking and retrieval of regulatory information.

2. Coordinate with cross-functional teams, including R&D, manufacturing, and quality assurance, to gather necessary data and documentation for dossier preparation.

3. Maintain a comprehensive understanding of dossier requirements and submission processes for various regulatory agencies.

4. Oversee the preparation of responses to regulatory queries and deficiency letters from health authorities.

5. Ensure timely and accurate preparation of eCTD (Electronic Common Technical Document) submissions, CTD (Common Technical Document), and variation submissions.

6. Manage the compilation, review, and submission of regulatory dossiers for new product registrations and lifecycle maintenance in EU and ROW markets.

Compliance Management and Lifecycle Activities

1. Manage and maintain regulatory archives and databases, ensuring accurate and up-to-date information.

2. Develop and deliver training programs on regulatory requirements and compliance procedures to relevant personnel.

3. Monitor and track regulatory changes and updates, ensuring timely communication and implementation within the organization.

4. Conduct regular audits and assessments to identify potential compliance gaps and implement corrective actions.

5. Manage product lifecycle activities, including variations, renewals, and post-approval commitments.

6. Oversee the implementation and maintenance of robust regulatory compliance programs to ensure adherence to GMP (Good Manufacturing Practice), GCP (Good Clinical Practice), and other relevant regulations.

Market Access and Regulatory Intelligence

1. Provide regulatory support for business development activities, including due diligence and licensing agreements.

2. Monitor competitor activities and identify potential regulatory challenges and opportunities.

3. Collaborate with commercial teams to develop and implement market access strategies.

4. Assess the regulatory impact of new product development projects and provide guidance on regulatory pathways.

5. Conduct regulatory intelligence gathering and analysis to identify emerging trends and opportunities.

6. Develop and implement strategies to optimize market access for pharmaceutical products in EU and ROW markets.

Cross-Functional Collaboration

1. Participate in cross-functional meetings and provide regulatory expertise and guidance.

2. Communicate regulatory information and updates to relevant stakeholders within the organization.

3. Liaise with quality assurance to ensure compliance with quality standards and regulatory requirements.

4. Work closely with manufacturing to ensure compliance with GMP requirements and address any regulatory issues related to manufacturing processes.

5. Provide regulatory input to product development teams, ensuring compliance with regulatory requirements throughout the product lifecycle.

6. Collaborate with R&D, Manufacturing, Quality Assurance, and Commercial teams to ensure alignment of regulatory strategies with overall business objectives.