Regulatory Manager

Job Description Asst Manager-Regulatory Affairs

Department: Regulatory Affairs

Job Location: Ahmedabad

Job Type: Full Time

Job Purpose

The candicate will be responsible for managing regulatory activities associated with Marketing Authorisation Applications (MAAs), including preparation regulatory documents, coordination of deficiency responses, regulatory query management, and provision of regulatory support to cross-functional teams. The role will involve close collaboration with internal teams, Contract Manufacturing Organisations (CMOs), external partners, consultants to ensure timely and compliant regulatory responses.

Key Responsibilities

1. Manage and coordinate deficiency responses for Marketing Authorisation Applications (MAAs), ensuring timely, accurate, and compliant response prepapration/review.

2. Prepare, compile, review, high-quality regulatory documents, ensuring accuracy, consistency, completeness, and compliance with applicable regulatory guidelines and requirements.

3. Ensure timely preparation and submission of responses to queries and requests for information received from relevant regulatory authorities.

4. Develop scientifically sound justifications, responses, and regulatory arguments to effectively address regulatory queries and deficiencies.

5. Collect, analyse, and critically evaluate scientific, technical, and clinical data to support regulatory submissions, deficiency responses, and regulatory strategies.

6. Review GMP-related documentation received from Contract Manufacturing Organisations (CMOs) to ensure completeness, accuracy, and compliance with applicable regulatory requirements.

7. Ensure appropriate regulatory documentation practices and maintain compliance with applicable global regulatory standards, guidelines, and internal procedures.

8. Provide regulatory support and guidance to internal cross-functional teams, including Quality, R&D, Supply Chain, Commercial, and other relevant functions.

9. Collaborate effectively with internal and external stakeholders to develop and align regulatory strategies and ensure successful execution of regulatory activities.

10. Communicate effectively with partners, CMOs, consultants, and other stakeholders to ensure timely availability of required data, documents, and supporting information.

11. Monitor regulatory project timelines, track key deliverables, and proactively follow up with relevant stakeholders to ensure activities are completed in accordance with agreed project plans and deadlines.

Qualifications

• Bachelor's or Master's degree in Pharmacy, Pharmaceutical Sciences, Life Sciences, or a related scientific discipline.
• A postgraduate qualification in Regulatory Affairs or a related field would be advantageous.

Experience

• Relevant experience in Regulatory Affairs within the pharmaceutical industry.
• Experience in preparation, review, and submission of regulatory documentation and responses to regulatory authority queries.
• Experience in handling regulatory deficiencies and coordinating responses with cross-functional teams and external stakeholders.
• Experience in reviewing CMO documentation, including GMP-related documents, would be advantageous.
• Experience with UK and/or EU regulatory requirements would be preferred.
• 6+ Years experience

Skills and Competencies

• Good understanding of pharmaceutical regulatory requirements and guidelines.
• Strong scientific and analytical skills with the ability to interpret and critically evaluate technical data.
• Strong written and verbal communication skills.
• Ability to prepare clear, concise, and scientifically sound regulatory responses and justifications.
• Strong attention to detail and commitment to accuracy and quality.
• Good organisational and project management skills, with the ability to manage multiple activities and competing priorities.
• Ability to work effectively with cross-functional and external stakeholders.
• Proactive approach to identifying and resolving regulatory issues.
• Strong interpersonal and collaboration skills.
• Proficiency in Microsoft Office applications, particularly Word and Excel.
• Ability to work independently while contributing effectively to a team environment.