Executive _ Regulatory & Business Continuity
Sun Pharmaceuticals, Inc, Indiana, PA, United States
Job Details
Job Title: Senior Executive / Manager 2 Regulatory Affairs
Business Unit: R&D1 Regulatory Affairs
Job Grade: G11A/G11B
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 collaborative spirit, knowing that we Thrive together and support each others journeys.
Overview Job Summary: Regulatory submission of new products, variations, response to queries, Life cycle management for ASEAN markets (mainly Thailand) through preparation of quality dossiers enabling timely approvals.
Responsibilities
New submissions:
Should be well-versed with country-specific requirements
Active participation in Regulatory strategy for new filings and LCM
Review & prepare CMC (Chemistry, Manufacturing and Controls) dossiers for fresh submissions
Review documents (Development report, scale up report, specification, stability protocol), artworks etc. before initiation of Exhibit batches for adequacy
Approval:
Review & prepare response to deficiency enabling approval of products filed to regulatory agency
Lifecycle management for drug formulations:
Prepare and review variations as per the country requirements to support approval of changes such as API, vendor changes/changes in ROS/test parameters; DF site changes; harmonization of products etc.
Prepare and review re-registration/PCH dossiers & submit the same to regional office/ regulatory agencies
Regulatory compliance:
Prepare, review and circulate approval package to stakeholders upon receipt of approval and update the same based on queries and variations
Ensure reposition of comprehensive product information into central repository
Review regulatory filing impact of variations, change controls, etc.
Travel NA
Job Requirements Educational Qualification M.S.c /M.Pharm
Experience Tenure: 2-8 years
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.
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Business Unit: R&D1 Regulatory Affairs
Job Grade: G11A/G11B
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 collaborative spirit, knowing that we Thrive together and support each others journeys.
Overview Job Summary: Regulatory submission of new products, variations, response to queries, Life cycle management for ASEAN markets (mainly Thailand) through preparation of quality dossiers enabling timely approvals.
Responsibilities
New submissions:
Should be well-versed with country-specific requirements
Active participation in Regulatory strategy for new filings and LCM
Review & prepare CMC (Chemistry, Manufacturing and Controls) dossiers for fresh submissions
Review documents (Development report, scale up report, specification, stability protocol), artworks etc. before initiation of Exhibit batches for adequacy
Approval:
Review & prepare response to deficiency enabling approval of products filed to regulatory agency
Lifecycle management for drug formulations:
Prepare and review variations as per the country requirements to support approval of changes such as API, vendor changes/changes in ROS/test parameters; DF site changes; harmonization of products etc.
Prepare and review re-registration/PCH dossiers & submit the same to regional office/ regulatory agencies
Regulatory compliance:
Prepare, review and circulate approval package to stakeholders upon receipt of approval and update the same based on queries and variations
Ensure reposition of comprehensive product information into central repository
Review regulatory filing impact of variations, change controls, etc.
Travel NA
Job Requirements Educational Qualification M.S.c /M.Pharm
Experience Tenure: 2-8 years
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.
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