Assistant Manager - Regulatory Affairs

Role & responsibilities

The AM- Regulatory Affairs is responsible for Indian regulatory affairs activities related to the GI & Olympus products. AM- Regulatory Affairs is also responsible for advising and consulting with stakeholders about compliance with CDSCO, BIS, WPC and other applicable regulatory bodies The AM- Regulatory Affairs will responsible for implement best practices, and contribute to both the strategic and operational functions of the regulatory affairs team.

• Assesses regulatory intelligence to assist in the development of local, regional, and global regulatory strategies
• Evaluates the regulatory environment and contributes to providing internal advice throughout the product lifecycle (e.g., concept, development, manufacturing, marketing) to ensure product compliance
• Anticipates regulatory obstacles and emerging issues throughout the product lifecycle and develops solutions
• Identifies requirements and potential obstacles for market access distribution (federal/provincial/territorial state, reimbursement, purchasing groups, etc.)
• Assists in the development of regulatory strategy and updates strategy based upon regulatory changes.
• Evaluates proposed products for regulatory classification and jurisdiction
• Determines requirements (local, national, international) and options for regulatory submission, approval pathways, and compliance activities.
• Provides regulatory information and guidance for product development and planning throughout the product lifecycle to the regulatory groups and others within the organization
• Compares regulatory outcomes with initial product concepts and recommends changes or refinements based on initial regulatory outcomes
• Negotiates with regulatory authorities throughout the product lifecycle Identifies the need for new regulatory procedures, SOPs, and participates in development and implementation
• Helps train stakeholders on current and new regulatory requirements to ensure organization wide compliance
• Assists other departments in the development of SOPs to ensure regulatory compliance
• Provides regulatory input and technical guidance on global regulatory requirements to product development teams
• Advises stakeholders of regulatory requirements for quality, preclinical, and clinical data to meet applicable regulations
• Assesses the acceptability of quality, preclinical, and clinical document for submission filing to comply with applicable regulations
• Evaluates proposed preclinical, clinical, and manufacturing changes for regulatory filing solutions and proposes plans/strategizes (if appropriate) for changes that do not require submissions
• Identifies, monitors, and submits applicable reports or notifications to regulatory authorities during the clinical research process
• Provides regulatory information and guidance for proposed product claims/labelling
• Ensures that the clinical and nonclinical data, in conjunction with regulatory strategy, are consistent with the regulatory requirements and support the proposed product claims
• Prepares and submits electronic and paper regulatory submissions according to applicable regulatory requirements and guidelines
• Monitors the progress of the regulatory authority review process through appropriate communications with the agency
• Communicates and interacts with regulatory authorities before and during the development and review of a regulatory submission through appropriate communication tools
• Works with cross-functional teams for interactions with regulatory authorities including panel meetings and advisory committees 3
• Evaluate and comply with the pharmacovigilance activities which includes the Recall, FSCA and Complaint management.
• Ensure that quality system requirements are effectively established and maintained in accordance with all applicable medical device regulations, including ISO 13485, GDP, and other standards
• Preparation and review of relevant standard operating procedures as per the current technicalities with respect to QMS and other applicable regulatory requirements. Also ensure compliance of different SOPs, Manuals and Regulatory guidelines.

Preferred candidate profile

• Business Acumen:- Ability to tap into one's knowledge of the business environment to further the organization's agenda

• Customer focus (Internal and External):- Focusing effort towards achieving Customer Delight in line with Olympus' values

• Execution Excellence:- Ensuring seamless execution of organizational/ departmental strategy to achieve results as per Olympus quality standards

• Domain Expertise:- Applying one's knowledge and expertise for the benefit of the organization

• Communication:- Ability to effectively transmit one’s message across to the recipient

• Developing Organizational Talent:- Fostering a culture of development within the organization to fulfill individual as well as organizational aspirations

• Team Leadership:- Keeping team motivated and engaged to work together towards organizational goals