Assistant Manager Regulatory Affairs

Role & responsibilities

Regulatory Submissions and Approvals:

• Prepare and submit dossiers for product registrations in ROW, Africa, LATAM, CIS, and ASEAN markets, ensuring adherence to country-specific guidelines and requirements.
• Coordinate with internal departments (R&D, Quality Assurance, Production) to compile the necessary technical documentation for regulatory submissions.
• Liaise with regulatory authorities and consultants in these regions to facilitate product approvals and resolve any queries or deficiencies.

Compliance and Documentation:

• Ensure compliance with local regulatory requirements, guidelines, and international standards (such as WHO, ICH, or country-specific regulations).
• Maintain accurate and up-to-date records of regulatory documents, approvals, and communications.
• Monitor and ensure compliance with post-marketing regulatory requirements, such as periodic updates, renewals, and reporting obligations.

Labeling and Packaging Compliance:

• Review and approve labeling and packaging materials to ensure they meet the regulatory requirements of each country in the assigned regions.
• Coordinate changes in labeling as per the updated guidelines and regulations from local health authorities.

Product Development Support:

• Work closely with product development teams to ensure regulatory requirements are considered during product formulation and development.
• Provide regulatory advice on technical issues related to injectables, including formulation, packaging, and stability studies.

Regulatory Intelligence:

• Stay updated on changes in regulations, guidelines, and standards in the ROW, Africa, LATAM, CIS, and ASEAN regions.
• Communicate any changes or updates in regulatory requirements to relevant departments and ensure compliance with new regulations.

Communication and Coordination:

• Act as a point of contact between the company and regulatory bodies in the assigned markets.
• Coordinate with external partners, consultants, and distributors to facilitate regulatory submissions and product launches.

Cross-functional Collaboration:

• Collaborate with Quality Assurance, Manufacturing, and R&D teams to ensure that regulatory requirements are met at every stage of product development and manufacturing.
• Support in audits and inspections conducted by regulatory agencies and provide necessary documentation and information.

Product Registration Lifecycle Management:

• Manage the entire lifecycle of product registrations, including initial submissions, renewals, variations, and amendments.
• Ensure timely submission of regulatory documents to maintain product approvals and licenses.

Risk Management and Problem-Solving:

• Identify potential regulatory risks and devise strategies to mitigate them, ensuring uninterrupted market access for products.
• Provide solutions and regulatory strategies to resolve any issues or challenges related to regulatory submissions.

Preferred candidate profile

Must have experience in Injectables dosage forms.

Perks and benefits