Manager Global Regulatory Affairs
3 weeks ago
Location – Head-Office, Bangalore, IN
BIOCON BIOLOGICS
Biocon Biologics, we are creating a model for the future of healthcare for all. We are a leading company in the biosimilars revolution where patients come first. Our ambition is to impact a billion lives and we do this by fostering a culture of affordable innovation, patient centricity, and disruptive thinking. We are a multicultural global company where employees have a purpose and passion to work closely with partners and patients. We have a long-term commitment to bring high quality affordable biosimilars to patients all over the globe. We have proven end to end expertise from clone development, manufacturing, clinical development, regulatory approvals to commercialization in developed and emerging markets.
Job Summary:
Accountable for development and execution of CMC regulatory strategies, marketing applications and Life Cycle Management for biosimilar products.
Development and Implementation of regulatory strategies for global registrations for products within the biosimilars portfolio
Coordination of activities and deliverables provided by other cross-functional teams to support the development, approval, and long-term planning of biosimilar products
Collaboration with partners to develop and execute global regulatory activities
Plan and manage development of high quality regulatory documents, including briefing documents, CTAs, IND / IMPD, MAA / BLA, and responses to questions for products in compliance with approved filing plans, timelines, and regulatory requirements
Provide regulatory direction on global regulatory requirements to support product development
Ensure all filings are maintained per regulatory requirements and consistent with biosimilar strategy throughout product development and life cycle
Support development and execution of clinical/non-clinical strategies
Provide review, input, and regulatory advice into study concept CMC documents, protocols and reports used to support product development and registration
Collaborate with partners affiliates as required to ensure effective implementation of approved global regulatory strategies and plans
With minimal supervision, participate in development of risk management and contingency planning
Ensure and lead regulatory compliance for biosimilar products
Participation in regulatory meetings with Health Authorities
Knowledge and Skills:
Comprehensive understanding of Regulatory activities
Regulatory experience with product filings
Team skills, especially in working with internal and external partners
Familiarity with project management requirements
Ability to understand and communicate scientific CMC information
Anticipate and prevent potential issues
Ability to communicate regulatory strategies and requirements to ensure expectations are understood
Education/Qualification:
B Pharm/M Pharm, B Tech/M Tech Biotech, BSc/MSc
A min of 5 years of experience in global regulatory affairs
Preference for folks who has global RA experience in advanced markets
-
Manager Global Regulatory Affairs
3 weeks ago
bangalore, India Biocon Biologics Full timeManager – Global Regulatory Affairs Location – Head-Office, Bangalore, IN BIOCON BIOLOGICS Biocon Biologics, we are creating a model for the future of healthcare for all. We are a leading company in the biosimilars revolution where patients come first. Our ambition is to impact a billion lives and we do this by fostering a culture of affordable...
-
Regulatory Affairs Manager II
2 weeks ago
Bangalore, India AstraZeneca Full timeJob Title: Regulatory Affairs Manager II (International Regulatory Affairs) Career Level - D Introduction to Role: Within International Regulatory Affairs, as Regulatory professionals, we take innovative regulatory approaches to bring life-changing medicines to patients in international markets. We work across the AZ pipeline and business to...
-
Manager Global Labelling Regulatory Affairs
3 weeks ago
bangalore, India Biocon Biologics Full timeBiocon Biologics, we are creating a model for the future of healthcare for all. We are a leading company in the biosimilars revolution where patients come first. Our ambition is to impact a billion lives and we do this by fostering a culture of affordable innovation, patient centricity and disruptive thinking. We are a multicultural global company where...
-
Manager Global Labelling Regulatory Affairs
2 weeks ago
bangalore, India Biocon Biologics Full timeBiocon Biologics, we are creating a model for the future of healthcare for all. We are a leading company in the biosimilars revolution where patients come first. Our ambition is to impact a billion lives and we do this by fostering a culture of affordable innovation, patient centricity and disruptive thinking. We are a multicultural global company where...
-
Manager Global Labelling Regulatory Affairs
3 weeks ago
bangalore, India Biocon Biologics Full timeBiocon Biologics, we are creating a model for the future of healthcare for all. We are a leading company in the biosimilars revolution where patients come first. Our ambition is to impact a billion lives and we do this by fostering a culture of affordable innovation, patient centricity and disruptive thinking. We are a multicultural global company where...
-
Regulatory Affairs Manager I
2 months ago
bangalore, India AstraZeneca Full timeJob Title: Regulatory Affairs Manager I Career Level - D Introduction to role: Join our dynamic Biopharmaceuticals R&D team as a Regulatory Affairs Manager I. This role is a unique opportunity for a regulatory specialist with project management capabilities to lead the end-to-end planning, coordination, and execution of assigned deliverables. You...
-
Regulatory Affairs Manager I
2 months ago
Bangalore, India AstraZeneca Full timeJob Title: Regulatory Affairs Manager I Career Level - D Introduction to role: Join our dynamic Biopharmaceuticals R&D team as a Regulatory Affairs Manager I. This role is a unique opportunity for a regulatory specialist with project management capabilities to lead the end-to-end planning, coordination, and execution of assigned deliverables. You...
-
Regulatory Affairs Manager I
3 weeks ago
bangalore, India AstraZeneca Full timeJob Title: Regulatory Affairs Manager I Career Level - D Introduction to role: Join our dynamic Biopharmaceuticals R&D team as a Regulatory Affairs Manager I. This role is a unique opportunity for a regulatory specialist with project management capabilities to lead the end-to-end planning, coordination, and execution of assigned deliverables. You...
-
Regulatory Affairs Manager I
3 weeks ago
Bangalore, India AstraZeneca Full timeJob Title: Regulatory Affairs Manager I Career Level - D Introduction to role: Join our dynamic Biopharmaceuticals R&D team as a Regulatory Affairs Manager I. This role is a unique opportunity for a regulatory specialist with project management capabilities to lead the end-to-end planning, coordination, and execution of assigned deliverables. You...
-
Regulatory Affairs Manager I
2 weeks ago
bangalore, India AstraZeneca Full timeJob Title: Regulatory Affairs Manager I Career Level - D Introduction to Role: Join our Biopharmaceuticals R&D team as a Regulatory Affairs Manager I, a role that offers the opportunity to contribute to our drug development strategies and turn them into reality. As a regulatory specialist with project management capabilities, you will be...
-
Regulatory Affairs Manager I
2 weeks ago
Bangalore, India AstraZeneca Full timeJob Title: Regulatory Affairs Manager I Career Level - D Introduction to Role: Join our Biopharmaceuticals R&D team as a Regulatory Affairs Manager I, a role that offers the opportunity to contribute to our drug development strategies and turn them into reality. As a regulatory specialist with project management capabilities, you will be responsible...
-
Manager Global Labelling Regulatory Affairs
3 weeks ago
Bangalore Urban, India Biocon Biologics Full timeBiocon Biologics, we are creating a model for the future of healthcare for all. We are a leading company in the biosimilars revolution where patients come first. Our ambition is to impact a billion lives and we do this by fostering a culture of affordable innovation, patient centricity and disruptive thinking. We are a multicultural global company where...
-
Manager Global Labelling Regulatory Affairs
2 weeks ago
Bangalore Urban, India Biocon Biologics Full timeBiocon Biologics, we are creating a model for the future of healthcare for all. We are a leading company in the biosimilars revolution where patients come first. Our ambition is to impact a billion lives and we do this by fostering a culture of affordable innovation, patient centricity and disruptive thinking. We are a multicultural global company where...
-
Manager Global Labelling Regulatory Affairs
2 weeks ago
Bangalore Urban, India Biocon Biologics Full timeBiocon Biologics, we are creating a model for the future of healthcare for all. We are a leading company in the biosimilars revolution where patients come first. Our ambition is to impact a billion lives and we do this by fostering a culture of affordable innovation, patient centricity and disruptive thinking. We are a multicultural global company where...
-
Regulatory Affairs Manager I
3 days ago
Bangalore, India AstraZeneca Full timeJob Title: Regulatory Affairs Manager I Career Level - D Introduction to Role: Join our Biopharmaceuticals R&D team as a Regulatory Affairs Manager I, a regulatory specialist with project management capabilities. This role is responsible for leading the end-to-end planning, coordination, and execution of assigned deliverables. You will be expected...
-
Associate Regulatory Affairs Director I
4 weeks ago
bangalore, India AstraZeneca Full timeJob Title: Associate Regulatory Affairs Director I (International Regulatory Affairs) Career Level - E Introduction to Role: Within International Regulatory Affairs, as Regulatory professionals, we take innovative regulatory approaches to bring life-changing medicines to patients in international markets. We work across the AZ pipeline and...
-
Associate Regulatory Affairs Director I
4 weeks ago
Bangalore, India AstraZeneca Full timeJob Title: Associate Regulatory Affairs Director I (International Regulatory Affairs) Career Level - E Introduction to Role: Within International Regulatory Affairs, as Regulatory professionals, we take innovative regulatory approaches to bring life-changing medicines to patients in international markets. We work across the AZ pipeline and business...
-
Regulatory Affairs Manager I
2 weeks ago
Bangalore, India AstraZeneca Full timeJob Title: Regulatory Affairs Manager I Career Level - D Introduction to Role: Join our dynamic International Regulatory Affairs team at AstraZeneca, where we are committed to bringing life-changing medicines to patients across the globe. We have an exciting opportunity for a Regulatory Affairs Manager I to contribute to our mission. In this role,...
-
Regulatory Affairs Manager
3 weeks ago
bangalore, India AstraZeneca Full timeAbout AstraZeneca AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development and commercialization of prescription medicines for some of the world’s most serious diseases. But we’re more than one of the world’s leading pharmaceutical companies. Position purpose For assigned...
-
Regulatory Affairs Manager
3 weeks ago
Bangalore, India AstraZeneca Full timeAbout AstraZeneca AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development and commercialization of prescription medicines for some of the world’s most serious diseases. But we’re more than one of the world’s leading pharmaceutical companies. Position purpose For assigned products:...
