**Job Title:** Regulatory and Business Continuity **Business Unit:** R&D1; Regulatory Affairs **Job Grade** G12A Executive **Location :** Baroda At Sun Pharma, we commit to helping you **Create your own sunshine** by fostering an environment where you grow at every step, take charge of your journey and thrive in a supportive community. Are You Ready to Create Your Own Sunshine? As you enter the Sun Pharma world, youll find yourself becoming Better every day through continuous progress. Exhibit self-drive as you Take charge and lead with confidence. Additionally, demonstrate a team-oriented spirit, knowing that we Thrive together and support each others journeys. **Job Description** + Review all data and documents related to product registrations for various health authorities. + Compile registration dossiers for submission to various health authorities like US-FDA, Health Canada, Europe, Australia/New Zealand, Japan and Israel. + Prepare responses to deficiency letters received from various agencies. + Maintain life-cycle / post approval changes for drug product registration dossiers. + Provide regulatory support to cross functional departments. + Prepare and submit scientific advice to various health authorities. + eCTD compilation, verification and submission through electronic gateway + Review, preparation and submission of annual reports to US FDA + Review,



preparation and submission of post approval supplements to US FDA + Reviewing of the plant change control and established the variation strategy for submission + Review of query response prepared and compiled by regulatory associates + Review of all the documents received from stake holder fordossier compilation, Query response and Life cycle management + Allocation of projects to regulatory associate & manage the team for all theregulatory submission activities **Travel Estimate** NA **Job Requirements** **Educational Qualification** M. Pharm **Experience** _Tenure_ : 4 8 Yrs. **Your Success Matters to Us** At Sun Pharma, your success and well-being are our top priorities! We provide robust benefits and opportunities to foster personal and professional growth. _Join us at Sun Pharma, where every day is an opportunity to grow, collaborate, and make a lasting impact. Lets create a brighter future together_ **_Disclaimer:_** _The preceding job description has been designed to indicate the general nature and level of work performed by employee within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees as assigned to this job. Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of incumbent(s)._ We provide equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, military or veteran status, generic predisposing characteristics or any other basis prohibited by law.

📌 Exe (Regulatory Affairs) (India)
🏢 Sun Pharmaceuticals
📍 India