Regulatory Affairs

Regulatory Affairs Specialist - CMC Variations/Submissions 12 month contract - Immediate start Overview: Join our Regulatory Affairs team and contribute to the management of Chemistry, Manufacturing, and Controls (CMC) You’ll be pivotal in ensuring compliance and efficiency in our regulatory processes. Key Responsibilities: CMC Change Control...

Regulatory Affairs Specialist - CMC Variations/Submissions12 month contract - Immediate startOverview: Join our Regulatory Affairs team and contribute to the management of Chemistry, Manufacturing, and Controls (CMC) You’ll be pivotal in ensuring compliance and efficiency in our regulatory processes.Key Responsibilities:CMC Change Control Assessment:...

Job Description We are seeking a Regulatory Affairs Specialist to support a leading medical device company in Ithaca, NY.  This is an onsite role open to local candidates.  Job Summary: This position will support worldwide regulatory registrations for our current and future medical devices as well as support process compliance in conjunction with our...

Provide regulatory support to customers/ internal teams and assist in maintaining regulatory requirements at all levels Coordinate for acquiring / renewal of FDA/FSSAI licenses, product approvals, chemist intimations/ approvals, maintain regulatory documentation and follow up on any Corrective action directed by the FDA officials Coordinate with Global...

Job Description Responsibilities The Senior Associate: Enterprise Risk and Regulatory Affairs will provide support: to the attainment of the overall objectives of the Enterprise Risk and Regulatory Affairs Department. in the planning, design and implementation of the enterprise-wide risk governance framework. to formulate regulatory and...

Opportunity to work with a leading pharmaceutical CompanyA great role to lead a team of Regulatory Affairs AssociatesJob DescriptionThe role is a part of Global Shared Service Centre for based out of Gurugram and will be responsible for managing team of associates within Biopharma domain who will be working on enclosed below responsibilities...

Job Description Regulatory Affairs Manager (European Union expertise)Medical Device Company. Tucson, AZOnsite (relo over time) 140k Talentry is looking for a Regulatory Affairs expert with medical device experience in the European Union (EM MDR).  This expert will aid in the preparation of documentation, submissions, applications, responses, adverse...

Specific activities and responsibilities: Review the drug product dossier section ( specifically 3.2.P.2 and 3.2.P.3 ) as per the EU regulatory requirement. Aware of regulatory requirements, and technical knowledge of various pharmaceutical dosage forms. Project coordination and management skills CMC regulatory requirements for other than...

Senior / Labelling Specialist Job Description: We are seeking a highly skilled and experienced Senior Labelling Specialist to join our team and take on a pivotal role in the development and approval of labelling documents for our vaccine portfolio. As a Senior Labeling Specialist, you will be responsible for overseeing all aspects of labeling, from initial...

Senior / Labelling SpecialistJob Description:We are seeking a highly skilled and experienced Senior Labelling Specialist to join our team and take on a pivotal role in the development and approval of labelling documents for our vaccine portfolio. As a Senior Labeling Specialist, you will be responsible for overseeing all aspects of labeling, from initial...

Who we are Together, we’re on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives. It’s a mission that bonds our people across nearly 60 countries and a rich, diverse variety of nationalities and backgrounds. Working here means working with the world’s leading manufacturer of generic...

Description Basic Information: Job Title: Head Advocacy & Corporate Affairs Grade: M3/M4 Reports To: CEO, FACOR Division/Department: Corporate Affairs Location: Bhubaneswar, Odisha Key Accountabilities 1. Stakeholder mapping and engagement with key State Government departments as per the business. 2. Co-ordinate with Government...

Roles and Responsibility About The Role The incumbent will report to IndiaGovernment Affairs Head and be based in Delhi (require some travel within India).  Responsibilities Support in the execution of publicpolicy campaign across the full range of policy areas thatimpact organisation’s business in the field of onlinegaming and...

Job Description : Job Title:Ideation Specialist (Medical Affairs)Job Category:Head Office Based Medical AffairsDepartment:Global Medical AffairsQualificationMBBS with MD/DM Pharmacology or Postgraduate in Pharmaceutical SciencesLocation:MumbaiTravel Required:YesReporting to:Team Lead for Ideation (Medical Affairs)Position Type:Full TimeExperience:Medical...

Qualifications : B.Pharm/ M. Pharm/ M.Sc. Location: For two years in Brazil Office followed by Office in Mumbai Job description Responsibilities Ensure change management, post approval changes to ANVISA Review of technical documents for new submissions, post approval changes (Individual Protocol, HMP). Writing PATE for post approval changes Respond to...

Head - Government Regulatory/Listing Obligation/Disclosure Regulation We are recruiting Head of Government Regulatory and Listing Obligation.- You will be closely working Global General Counsel on various regulatory compliance and government affairs strategy in India. - Cultivates and nurtures strong relationship with key stakeholders in Indian government...

Head - Government Regulatory/Listing Obligation/Disclosure Regulation We are recruiting Head of Government Regulatory and Listing Obligation. You will be closely working Global General Counsel on various regulatory compliance and government affairs strategy in India. Cultivates and nurtures strong relationship with key stakeholders in Indian government...

Job Description Healthcare Quality & Regulatory Compliance Specialist (Hybrid) AMEAOpportunity: Play a critical role in driving compliance and quality programs for Healthcare Transportation and facilities and supporting the Healthcare Quality Management System to ensure processes and systems are compliant with regional and local regulations and customer...

Work with a leading pharmaceutical giantExcellent work culture that offers multiple growth opportunitiesJob DescriptionReporting into the 'Head Regulatory', your responsibilities would include the following:Develop and execute robust regulatory strategies, leveraging your expertise to navigate global regulatory agencies such as US-FDA, EMA, TGA, Health...

JOB PURPOSE Support GM (Cargo Regulatory Affaire & QC) in simplification of Cargo clearance processes with Customs & other Government Regulatory bodiesIssues pertaining to bottlenecks in Cargo clearance processes which have already been identified and taken up with local Commissionerate and CBEC (20 Nos. issues);Pursue open issues by studying the...