Regulatory Affairs Manager – ADC
Location: Mumbai, India
Experience Required: Minimum 7 years
Work Mode: On-site
Job Summary
Join a leading pharmaceutical company as a Regulatory Affairs Manager – ADC based in Mumbai. This role is ideal for a seasoned regulatory affairs professional with over 7 years of experience in pharmaceutical, biologics, or medical device product registration. You'll be a key contributor in managing complex submissions, interacting with regulatory bodies, and shaping lifecycle strategies across products, including CMC and technical labeling.
Key Responsibilities
Lead the development and submission of regulatory dossiers including NDAs, BLAs, amendments, and supplements.
Liaise directly with regulatory authorities to facilitate approvals.
Act as regulatory representative across internal cross-functional teams.
Support lifecycle management activities for existing products.
Participate in product planning, regulatory strategy, and risk mitigation.
Provide regulatory input for manufacturing changes, technical labeling, and market expansions.
Ensure full compliance with local and international regulations including CMC.
Required Skills & Qualifications
Associate's Degree or higher in a life science or regulatory discipline.
Minimum of 7 years' experience in Regulatory Affairs in pharmaceuticals, biologics, or medical devices.
Hands-on experience with regulatory submissions and interactions with authorities.
In-depth knowledge of global regulatory requirements and CMC documentation.
Excellent communication and cross-functional collaboration skills.
Perks & Benefits
Competitive salary based on experience and market standards.
Exposure to global product submissions and regulatory strategy.
Collaborative work environment with seasoned regulatory experts.
Continuous learning opportunities in a dynamic global regulatory landscape.
Company Description
We are a global healthcare leader committed to bringing innovative medicines, biologics, and medical devices to market. Our regulatory affairs teams play a pivotal role in shaping product success across the globe. We promote integrity, innovation, and impact in everything we do.
Work Mode
On-site – Mumbai, India
Call-to-Action
Are you ready to lead critical regulatory submissions and contribute to life-changing healthcare innovations?
Apply now to join as a Regulatory Affairs Manager in Mumbai.
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Regulatory Affairs Manager – ADC
Location: Mumbai, India
Experience Required: Minimum 7 years
Work Mode: On-site
Job Summary
Join a leading pharmaceutical company as a Regulatory Affairs Manager – ADC based in Mumbai. This role is ideal for a seasoned regulatory affairs professional with over 7 years of experience in pharmaceutical, biologics, or medical device product registration. You'll be a key contributor in managing complex submissions, interacting with regulatory bodies, and shaping lifecycle strategies across products, including CMC and technical labeling.
Key Responsibilities
Lead the development and submission of regulatory dossiers including NDAs, BLAs, amendments, and supplements.
Liaise directly with regulatory authorities to facilitate approvals.
Act as regulatory representative across internal cross-functional teams.
Support lifecycle management activities for existing products.
Participate in product planning, regulatory strategy, and risk mitigation.
Provide regulatory input for manufacturing changes, technical labeling, and market expansions.
Ensure full compliance with local and international regulations including CMC.
Required Skills & Qualifications
Associate's Degree or higher in a life science or regulatory discipline.
Minimum of 7 years' experience in Regulatory Affairs in pharmaceuticals, biologics, or medical devices.
Hands-on experience with regulatory submissions and interactions with authorities.
In-depth knowledge of global regulatory requirements and CMC documentation.
Excellent communication and cross-functional collaboration skills.
Perks & Benefits
Competitive salary based on experience and market standards.
Exposure to global product submissions and regulatory strategy.
Collaborative work environment with seasoned regulatory experts.
Continuous learning opportunities in a dynamic global regulatory landscape.
Company Description
We are a global healthcare leader committed to bringing innovative medicines, biologics, and medical devices to market. Our regulatory affairs teams play a pivotal role in shaping product success across the globe. We promote integrity, innovation, and impact in everything we do.
Work Mode
On-site – Mumbai, India
Call-to-Action
Are you ready to lead critical regulatory submissions and contribute to life-changing healthcare innovations?
Apply now to join as a Regulatory Affairs Manager in Mumbai.
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