Title:  Lead- Regulatory Writing

Job Description

We are a technology-led healthcare solutions provider. We are driven by our purpose to enable healthcare organizations to be future-ready. We offer accelerated, global growth opportunities for talent that’s bold, industrious, and nimble. With Indegene, you gain a unique career experience that celebrates entrepreneurship and is guided by passion, innovation, collaboration, and empathy. To explore exciting opportunities at the convergence of healthcare and technology, check out www.careers.indegene.com Looking to jump-start your career? We understand how important the first few years of your career are, which create the foundation of your entire professional journey. At Indegene, we promise you a differentiated career experience. You will not only work at the exciting intersection of healthcare and technology but also will be mentored by some of the most brilliant minds in the industry. We are offering a global fast-track career where you can grow along with Indegene’s high-speed growth. We are purpose-driven.  We enable healthcare organizations to be future ready and our customer obsession is our driving force. We ensure that our customers achieve what they truly want. We are bold in our actions, nimble in our decision-making, and industrious in the way we work.

Must Have

The Regulatory Lead role is responsible for managing regulatory operations including initial submissions and life cycle management of products, ensuring regulatory compliance in all marketed regions. This includes:
•    Planning and execution of new product registrations, line extensions, new indications, license renewals, variations management and label updates throughout the life cycle of a marketed product ensuring compliance with local regulations and quality system requirements.
•    Preparing, reviewing, and submitting regulatory dossiers for marketing authorization (MA) applications, ensuring timely and high-quality submissions in compliance with Health Authority regulations including but not limited to US, CA, EU, LATAM, APAC, GCC, and CIS countries.
•    Managing post-approval activities, preparing and submitting applications for registration and import licenses, renewals, variations and ensuring compliance and timely renewals of regulatory commitments, while working with the client, and their local affiliated as applicable.
•    Building and leading excellence focused team ensuring key operational metrics and compliance standards, maintaining high levels of accuracy and efficiency.
•    Facilitating and cultivating relationships with local Regulatory Agencies/affiliates and Health Authorities to achieve successful outcomes and strategic alignment for submissions and schedules in each country.
•    Ensuring Regulatory submissions and subsequent HA communication/responses within planned timelines.
•    Voicing affiliate perspectives and needs to global and regional regulatory contacts.
•    Maintaining regulatory tools in alignment with defined compliance metrics. Staying aware of current regulations and anticipating the implications and opportunities of changes in the regulatory environment. Communicating changes to appropriate management and cross-functional experts and implementing them locally.
•    Addressing complex regulatory and business challenges, collaborating across functions and regions to drive favourable outcomes and acting as a subject matter expert, assisting team members with troubleshooting and presenting solutions to project-related problems.
•    Assessing change control issued by quality or regulatory departments, evaluating regulatory impact, and developing submission strategies.
•    Ensuring accurate documentation and management of regulatory activities and data, maintaining and updating local Regulatory Affairs SOPs in adherence to quality standards.
•    Leading meetings with clients to discuss proposals, project status, and general business development activities.
•    Developing and implementing long-term regulatory optimization and streamlining initiatives to enhance compliance and business efficiency.
Requirements:
•    BPharm, MPharm, Pharm D, or MSc.
•    8-10 years in Regulatory Affairs and Submissions Management.
•    Experience with life-cycle management activities (e.g. Europe, USA, International would be an asset)
•    In Depth knowledge in Regulatory Affairs and experience of working in a global regulatory environment including exposure to registration procedures (EU - CP, MRP, DCP, National etc.) and LCM strategies
•    Familiarity with Veeva RIMS, TrackWise, and other RIMS systems.
•    Strong project management and documentation skills, proactive communication approach
•    Great customer service skills, able to work well and manage a team
•    Advanced skills in Microsoft Office and Adobe Professional.

Good to have

EQUAL OPPORTUNITY

Indegene is proud to be an Equal Employment Employer and is committed to the culture of Inclusion and Diversity. We do not discriminate on the basis of race, religion, sex, colour, age, national origin, pregnancy, sexual orientation, physical ability, or any other characteristics. All employment decisions, from hiring to separation, will be based on business requirements, the candidate’s merit and qualification. We are an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, national origin, gender identity, sexual orientation, disability status, protected veteran status, or any other characteristics.