About the organization:

Biocon Biologics is a fully-integrated pure play biosimilars organisation globally committed towards transforming patient lives through innovative and inclusive healthcare solutions. It is engaged in developing high-quality, affordable biosimilars aimed at expanding patient access to cutting-edge class of therapies across the world. Biocon Biologics is a subsidiary of Biocon Ltd, an innovation led-global biopharmaceuticals company and India's rst publicly listed biotech enterprise. Biocon Biologics has one of the largest biosimilars portfolios, a wide global footprint, state-of-the-art manufacturing facilities, world-class R&D ecosystem, and high quality & compliance standards, enabling it to fulfil unmet needs of patients across the globe.

With the scientific capabilities, scale of manufacturing, large product pipeline, strong talent pool and expertise in developing and commercialising biologics, the company aims to serve 5 million patients through its biosimilar and reach USD 1 billion revenue mark in FY22.

A. Role

The senior team member of Biocon Biologics Legal function will be responsible for various legal aspects in India including

(a) providing general legal advice including issues like regulatory compliance, contracts, protection of company Intellectual Property and other rights and employment laws; 

(b) act as key representative for implementing ethics and compliance program and initiative; 

(c) providing legal opinions in areas where legal clarification is needed, as well as conduct legal due diligence and draft due diligence reports to advice the company on matters related to the acquisition of new assets.

Reporting: Head - Compliance and Ethics

Location: Bangalore

Detailed Job Description

- Creating and implementing an effective compliance program; Oversee, coordinate, and monitor the day-to-day compliance activities of the business unit

- Ensuring that the compliance program effectively prevents and/or detects violation of law, regulations, organization policies, or the code of conduct

- Regularly reviewing the compliance program and recommending appropriate revisions and modifications, including advising leadership of potential compliance risk areas

- Coordinating resources to ensure the ongoing effectiveness of the compliance program; Tracking all issues referred to the Global Ethics and Compliance office

- Implementing and operating retaliation-free reporting channels, including an anonymous telephone reporting system available to all employees, volunteers, customers, and vendors

- In consultation with the corporate law department, establish a company compliance manual; maintain and supplement the manual as necessary

- Establish, supervise, and train teams of department compliance officers responsible for identifying compliance issues at the departmental level; ensure appropriate communication for compliance issues between local and corporate levels

- Develop and coordinate appropriate compliance training and education programs for all employees, agents, contractors, or others working with the organization; ensure and understand the company's commitment to comply with all laws, regulations, company policies, and ethical requirements applicable to the conduct of the business; assess the need for additional training and education and develop appropriate compliance programs

- Develop, coordinate, and/or oversee internal and external audit procedures for the purpose of monitoring and detecting any misconduct or noncompliance; if any misconduct or noncompliance is detected, recommend a solution and follow up to ensure that the recommendations have been implemented

- Formalize and monitor a system to enable employees to report any noncompliance without fear of retribution, ensuring that the reporting system is adequately publicized and that allegations of noncompliance are investigated and responded to promptly

- Ensuring that the internal controls are capable of preventing and detecting significant instances or patterns of illegal, unethical, or improper conduct by employees, agents, contractors, or others working with Biocon Biologics

In consultation with the human resources department, help ensure that there is a mechanism in place for disciplining instances of noncompliance (including the failure to prevent, detect, or report any noncompliance), appropriate to the nature and extent of the deviation and ensure consistency in the application of disciplinary action

- Work with the human resources department to ensure a work force with high ethical standards, including the establishment of minimum standards for conducting appropriate background and reference checks on potential employees

- In conjunction with the corporate legal department, interface and, when appropriate, negotiate with external regulatory agencies

- Report to the compliance committee at its regular meetings, or as otherwise necessary, on any significant compliance issues to ensure appropriate discussion of such compliance issues and to ensure that appropriate action is taken

- Managing complex and diverse litigation involving commercial and government contracts, product liability, vendor, customer and distributor disputes, real estate, intellectual property, environmental, insurance coverage, antitrust, unfair trade practices, false advertising, personal injury and property damage claims

- Carry out additional duties and responsibilities as assigned by the Head Legal from time to time.

Education and Experience/Skill Required

- Law degree preferred with minimum of 6+ years PQE in industry-specific law

- Proven ability in effectively conducting legal research in resolving complex issues

- Reputed law firm experience a plus; auditing experience is a plus

- Experience in dealing with compliance issues preferred

- Strong verbal and written communication skills

- Strong influencing skills and perseverance in investigating.

- Solutions driven approach, with exemplary initiative taking and problem-solving skills

- Ability to drive and manage professional relationships

- Ability to prioritise and deliver results well before deadlines

- Driven to pro-actively work towards establishing systems and an unflinching zeal to grow

- Outstanding organizational skills and ability to manage multiple tasks concurrently

Seniority Level - Mid-Senior level

Industry - Biotechnology

Employment Type - Full-time

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