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Aurigene Pharmaceutical Services Limited is leading contract research, development, and manufacturing organization (CDMO). With a strong legacy of services in discovery, development, and manufacturing we are ideally positioned to serve global pharma and specialty companies worldwide.
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Our endeavor is to help accelerate the journey from laboratory to market by providing access to our capabilities, knowledge, and experience. Our team of highly qualified and experienced scientists and engineers backed by the state-of-the-art infrastructure, work relentlessly for the success of our clients.
Our integrated service offerings range from discovery chemistry, discovery biology, custom development, and manufacturing of clinical compounds to enable your IND/NDA filings and commercial contract manufacturing. Our discovery and development services are offered from world-class R&D centers situated in India. This is supported by scale-up and commercial manufacturing facilities in India, UK, Mexico, and the United States.
Position: Lead – Regulatory Affairs
Location: Miyapur, Hyderabad, Telangana, India
Job Description:
Roles and Responsibilities
- PFI/RFP preparation:Â Provide inputs to the BD/ Marketing team on regulatory aspects; give technical inputs to strategy, design, and regulatory services we offer in order to ensure a complete aspect of regulatory interface with our CDMO business.
- Product Development:Â Guide development and RA team in providing inputs during product development on regulatory strategy, labeling, the number of excipients used, dissolution method acceptance, specifications finalization, data reports required for submission of dossier, etc. in order to ensure product development as per regulatory requirements of different geographies.
- Dossier compilation:Â Creation, review, and supply relevant section of CTD to the customer for their review and filling in order to ensure timely delivery of dossiers.
- Deficiency Response:Â Facilitate response compilation on behalf of the customer as per the scope defined in the contract for any deficiency received from agencies in order to ensure timely launches of new products
- Site Registrations and License management:Â Drive site preparedness for registration of APSL R&D and manufacturing site to ensure timely license and renewals for developing and manufacturing products in order to ensure timely registrations and licenses availability.
- Audit Support:Â Extend support during regulatory audits by guiding & equipping the QA/plant teams in order to ensure successful closure of regulatory audits
- Building High-Performance Team:Â Select right talent, manage talent management & engagement; Facilitate in the development of leadership pipeline & coach the HiPos to groom them for critical roles in order to create high performing teams
Desired Candidate Profile
Experience in multi-geography Regulatory Affairs with the diversity of work experience with IND/ NDA dossier compilation and review and Communication with FDA/EU / Indian authorities. Experience in the local Indian regulatory system.
Qualification: MS/M.Sc/M.Pharma/Ph.D (Chemistry)
Experience: 14-20 Years
Salary: Negotiable
Contact Details:
Ms. Jyothi S
jyothi_s@aurigeneservices.com
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