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Job Description: Regulatory Affairs Manager/Senior Manager

Position Title: Regulatory Affairs Manager/Senior Manager

Location: Ahmedabad

Reports To: Managing Director

Job Summary

The Regulatory Affairs Manager/Senior Manager will be responsible for managing and coordinating regulatory activities to ensure compliance with global, regional, and local regulatory requirements. This includes preparing regulatory submissions, maintaining regulatory documentation, and collaborating with cross-functional teams to meet product development and approval goals. The role requires strong regulatory knowledge, attention to detail, and the ability to work effectively with internal and external stakeholders to support business objectives.

Key Responsibilities

Regulatory Strategy and Compliance

• Assist in the development and implementation of regulatory strategies for new and existing products in alignment with global regulatory requirements.
• Ensure regulatory compliance for products in accordance with guidelines from authorities such as Health Canada, INVIMA, ANVISA, EMA, COFEPRESS, and other relevant regional agencies.
• Monitor changes in regulatory guidelines, industry standards, and market conditions, and assess their impact on the organization's products and regulatory strategy.
• Advise internal teams (R&D, manufacturing, labelling, clinical, etc.) on regulatory requirements related to product development, manufacturing, and advertising.

Regulatory Submissions and Approvals

• Prepare, review, and submit regulatory dossiers (eg, IND, NDA, ANDA, MAAs) for product approval and market authorization in compliance with regulatory standards.
• Coordinate and lead responses to regulatory authorities' queries, ensuring timely and accurate replies.
• Assist in the preparation and submission of updates, renewals, amendments, and variations in accordance with product lifecycle management.

Cross-functional Collaboration

• Work closely with external teams (R&D, QA/QC, clinical, and manufacturing) to ensure the timely and compliant execution of product development plans.
• Provide regulatory guidance to product development teams to ensure that regulatory requirements are considered at each stage of the product lifecycle.
• Collaborate with business development, marketing, and sales teams to understand market needs and regulatory requirements for new and existing products.

Regulatory Documentation and Reporting

• Maintain accurate and up-to-date regulatory documentation for products, ensuring compliance with all regulatory requirements.
• Ensure proper tracking and management of regulatory submissions and approvals for each product.
• Support the preparation and maintenance of internal reports, tracking project milestones and submission deadlines.

Stakeholder Engagement

• Serve as a point of contact for regulatory queries from internal stakeholders and external partners, including regulatory agencies and consultants.
• Represent the company in meetings with regulatory bodies and industry forums when needed.
• Assist in building and maintaining relationships with regulatory authorities and other external partners.

Qualifications and Experience

Education

• Bachelor's or master's degree in pharmacy, Life Sciences, or a related field. Additional certifications or advanced degrees (Ph.D., MBA) are desirable.

Experience

• Minimum of 6-8 years of experience in regulatory affairs within the pharmaceutical or life sciences industry.
• Experience in regulatory submissions (IND, NDA, ANDA, MAAs) and interacting with global regulatory agencies.
• Familiarity with regional regulatory requirements and product registration processes.

Skills and Competencies

• In-depth knowledge of international regulatory guidelines and industry standards.
• Strong attention to detail and ability to manage multiple projects with varying timelines.
• Excellent communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams.
• Ability to interpret and apply regulatory requirements to support product development and approval.