...the Annual Report schedule.
Retaining all supporting documentation as required in completing an Annual Report.
Notifying Regulatory Affairs Manager or designee (and Quality, if required) that an Annual Report is at risk of being submitted late.
Decision Making:...
...difference with.
The opportunity
The RA Associate II, under direct supervision, is... ...electronic proofreading tool TVT.
Work with US Regulatory Labeling Team to ensure assigned projects... ...experience, specifically in Regulatory Affairs with a focus on US Gx labeling...
Key Deliverables
Dossier review and complication of ANDAs for US Market.
Post approval for US
Document review i.e. Specifications, batch records, method validation documents, Stability data, container closure system, DMF review.
Hands on Electronic Operation (eCTD...
...rewards that will take you further.
Regulatory Compliance
As part of Global Risk, Regulatory... ...role of the Vice President Regulatory Affairs involves following responsibilities:... ...Maintain awareness of operational risk associated with role and responsibilities and minimize...
...About the role:
Reporting to the Head of Regulatory Affairs you will be a key member of the team which is responsible for providing strategic... ...Mentor and/or manage other Regulatory Managers Regulatory Associates and other junior level or administrative Regulatory staff...
...We are currently seeking a highly motivated and experienced professional in Regulatory Affairs specializing in Medical Devices to join our team.
Job Titles: Executive / Senior Executive / Assistant Manager - Regulatory Affairs
Experience: 3 to 9 years
Location: Andheri...
...ensure the timely submission of the labels to health authority.
Job Responsibilities
Responsible for coordination & preparation of regulatory submissions and strategies.
Prepare and submit all the supporting documents for labelling submissions as per the type of...
...Position Overview:
~ Handling assigned activities in the regulatory department.
Experience:
~5-8 years
Qualification:
~ B. Pharm, M.Pharm preferred.
Responsibilities:
Compilation of ANDA submissions in accordance with the latest guidances...
...database records pertaining to approved products in line with systems, processes and procedures.
Leading and/or coordinating regulatory affairs projects, as assigned.
Preparation of submission and approval notifications for applications submitted to Regulatory agencies...
...event in Delhi 2022.
Responsibilities
Support in creating regulatory and quality policy plan as needed internally and externally
Work... ...Requirement
Good understanding of the latest regulatory affairs
Ability to quickly prioritize and execute tasks
Strong analytical...
...Organization for PE and BE studies.
Coordination with ANVISA for technical queries
Desired Skills
Complete knowledge of ANVISA regulatory guidance
Proficient in new product submissions for solid oral dosages, parental/sterile formulations to ANVISA
Reading/Writing...
...Lead consultant, Regulatory Affairs Pharmaceutical - LIF016391
Genpact (NYSE: G) is a global professional services and solutions firm delivering outcomes that shape the future. Our 125,000+ people across 30+ countries are driven by our innate curiosity, entrepreneurial agility...
Pharmaceutical manufacturing company at Andheri East, Mumbai, having a vacancy for Regulatory Affairs.
B.Sc/B Pharma and should have experience as Regulatory Affairs in Pharma company
Job Profile: Regulatory Affairs & Compliance of Pharma company
Preparing dossiers...
...Lead consultant, Regulatory Affairs Pharmaceutical - LIF016236
With a startup spirit and 115,000 + curious and courageous minds, we have the expertise to go deep with the world’s biggest brands—and we have fun doing it! We dream in digital, dare in reality, and reinvent the...
...First Class B.Pharm with Masters degree in Pharmaceutical Regulatory Affairs / Pharmaceutics.
Registration as a pharmacist under the Pharmacy... ..., industry and/or profession in which 5 years must be Associate Professor in PCI approved/recognized Pharmacy college.
Experience...
...Responsibilities
Support in creating regulatory and quality policy plan as needed internally and externally
Work with internal personnel... ...to the candidate with 3+ years experience in regulatory affairs
Ability to quickly prioritize and execute tasks
Experience...
...The Sr. Manager, Regulatory Affairs will be responsible for overseeing regulatory activities related to clinical trials conducted by the clinical research organization. This position will play a crucial role in ensuring compliance with regulatory requirements and providing...
...regulations.
To liaise with stakeholders to identify forthcoming regulatory challenges and proactively seek expert input to resolve issues... ...engagement.
Highly motivated and experienced regulatory affairs professional
Comfortable working with different cultures and...
...implementation of the change.
Co-ordination with GRA, Country regulatory affiliates and COE for submission of dossier and supporting the... ...you
Experience : (8-12 years of experience in Regulatory Affairs, Quality Assurance)
Soft skills : Transversal skills, Stakeholders...
...we are embarking on an exciting journey to expand our reach globally.
Role and Responsibilities:
We are seeking a Manager Regulatory Affairs to join our team. In this role you will be responsible for supporting the creation of regulatory and quality policies both internally...
...Experience
Minimum 2 to 3 years relevant experience in handling Europe market.
Overall total experience in Regulatory of 3-5 years
Competencies
Good communication skills both spoken and written English.
Should be well versed with using excel sheets, Power Point...
...The Scientific & Regulatory Affairs (SRA) Manager, APAC, should be comfortable to travel between the two cities, as required
The ideal... ...legislations.
Where needed, represent company interests in trade associations to positively influence industry positions & future...
...The PCO based colleague Assistant Manager responsible for the regulatory activities both (Operational & Strategy) for assigned Portfolio (... ...Colleagues, RRL, HSM, HLM, GRRS team etc. ,
External Interaction: Government Health Authority, BoH, etc. ,
Regulatory Affairs
#LI-PFE
...Description
You are a strategic thinker passionate about driving solutions in Reporting . You have found the right team
Regulatory Operations CoE caters to private clients globally with offices in the US, Europe and Asia. The team is part of the Asset & Wealth Management...
Rs 2.4 - 4.2 lakhs p.a.
...work frequently with other employees and team members to coordinate complex activities, often with competing priorities.
Most regulatory affairs positions are full time.
Regulatory Responsibility means a duty or responsibility, assigned to an individual by...
...Regulatory lead will support in providing CMC strategy for drug substance and drug product during different clinical phases.
Responsible for product registration, approval and regulatory compliance throughout product life cycle.
The individual will be involved in CMC...
...pursuit of better.
Inviting applications for the role of Manger Regulatory Affairs, Labelling for USA market
In this role Candidate should... ...(PM and packaging components), including: CCDS updates and associated label negotiation and HC mandated label updates. Also, the...
...Job Description
You are a strategic thinker passionate about driving solutions in Regulatory Reporting . You have found the right team.
As the Regulatory Reporting Professional in our Finance team, you will spend each day defining, refining and delivering set goals...
...Manger Regulatory Affairs, Labelling for USA market - LIF014460
With a startup spirit and 115,000 + curious and courageous minds, we have... ...development (PM and packaging components), including: CCDS updates and associated label negotiation and HC mandated label updates. Also, the...
Job Description (KRA to be Delivered):
Coordinate with Legal Consultants for Legal Due Diligence, Fund Raise SSA and SHA
Skillfully draft and review a variety of legal agreements and contracts.
Develop and implement legal strategies aligned with organizational goals...