DM- Regulatory Affairs

About Olympus:

Olympus Medical Systems India Private Limited commenced its business operation in Indian market on April 1, 2010. Olympus Medical Systems India is a wholly owned subsidiary of Olympus Corporation. Taking a plunge into the Indian

market, team at Olympus wants to be the most respected reliable and chosen brand in health care domain. Olympus established its direct presence to build a very strong marketing and service facilities. With better and innovative

technology, Olympus looks forward to growing its foothold into the market with the growth in Indian Economy.

Business Overview:

Olympus Medical Systems India has a wide portfolio of products that are equipped with the latest innovative and superiortechnology. Olympus deals primarily in three verticals i.e. Gastrointestinal, Respiration & Surgical divisions and contributeto the medical society with state of the art product categories that includes, Video Endoscopy, Endoscopic Ultrasound,Bronchoscopy, Endo therapy devices in Gastrointestinal & Respiratory range whereas Surgical division includes Highdefinition imaging system and Energy products to deal with Laparoscopy, General Surgery, Gynecology and Urology field. Olympus also has a wide range of Scientific Solutions Product into the non-medical segment. The Scientific Solutions Business provides microscopes, which Olympus has been manufacturing since its inception. These microscopes are used

in various fields, whether for conducting such clinical examinations as blood tests or pathological examinations related to

cancer diagnosis, assisting advanced research in the life science and medical fields, or performing quality control on

manufacturing lines. Furthermore, the industrial video-scopes and ultrasonic flaw detectors offered in this business are used in inspections and examinations underpinning the safety of social infrastructure. The DM- Regulatory Affairs is responsible for Indian regulatory affairs activities related to the GI & Olympus products. DM- Regulatory Affairs is also responsible for advising and consulting with stakeholders about compliance with CDSCO

Role Overview:

BIS, WPC and other applicable regulatory bodies The DM- Regulatory Affairs will responsible for implement best practices, and contribute to both the strategic and operational functions of the regulatory affairs team.

Illustrative Responsibilities Assesses:

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 basedoninitial 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 processProvides 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 claimsPrepares 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 aregulatory submission through appropriate communication tools. Works with cross-functional teams for interactions with regulatory authorities including panel meetings and advisory committees

Minimum requirements:

Qualification – M. Pharma/B Pharma along with PG Diploma in Drug Regulatory Affairs, Preferred Experience –•••Dedicated 12 to 15 years of working experience in a customer-oriented position in an international organization.MS Office (focus Excel)Fluent in oral/written communication (English)

Competencies:

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 a team motivated and engaged to work together towards organizational goals