Average salary: Rs638,180 /yearly
More stats ...Support in creating regulatory and quality policy plan as needed internally and externally
Work with internal personnel and external... ...dossiers
Requirement
Good understanding of the latest regulatory affairs
Ability to quickly prioritize and execute tasks
Strong...
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...
...About the role:
Reporting to the Head of Regulatory Affairs you will be a key member of the team which is responsible for providing... ...and progress updates on regulatory workload at weekly/biweekly internal regulatory meeting
Interpret applicable regulations and guidelines...
...Role Purpose :
The role of the Vice President Regulatory Affairs involves following responsibilities:
Scan for legal and regulatory... ...in accordance with applicable laws, rules, regulations, and internal policies.
Work with Country Compliance team members to monitor...
...requirements and plan the submission based on priority.
Maintains user-level knowledge of labelling software's
Interacts with other internal departments when necessary.
Shows initiative to remain current on new labelling regulations and international guidelines and seeks...
...a highly motivated and experienced professional in Regulatory Affairs specializing in Medical Devices to join our team.
Job Titles... ...globe to get approvals for the devices.
5. Coordination with the International Sales Team for the registrations in their respective countries....
...Job Title: Manager -Medical Affairs
Department: Medical Affairs
Location: Kandivali (West), Mumbai
Qualification & Experience:
· MD Pharmacology with 1year experience in medico-marketing.
Key Responsibilities:
· Scientific support for New Product launches...
...Inviting applications for the role of Lead Consultant Regulatory Affairs, CMC and labelling for Dubai market
In this role Candidate... ...registered in Dubai market.
. Responsible for maintaining internal tracker for DMF, renewal, labelling and CMC submissions as per...
...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:
Own...
...Music & Merchant Records . Our vision to introduce and cultivate international best practices, developing and creating avenues for Indian... ...Role
This newly created role will provide Legal and Business Affairs support to Sony Music Publishing India with a focus on drafting...
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....
...Labeling experience.
Relevant years of experience: 4 plus years (Pharmaceutical industry experience, specifically in Regulatory Affairs with a focus on US Gx labeling
Knowledge and Skills
Individual must:
Be able to multi-task in a fast-pacedwork environment....
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...
...Job Title: Legal Affairs Specialist
Industry: Industrial / Manufacturing
Location: Mumbai Maharashtra
Education: Bachelor... ...updates on litigation matters to Borosil.
Collaborating with internal and external stakeholders to develop litigation plans.
Identifying...
...Support in creating regulatory and quality policy plan as needed internally and externally
Work with internal personnel and external... ...Preference to the candidate with 3+ years experience in regulatory affairs
Ability to quickly prioritize and execute tasks
Experience...
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...
...The Sr. Manager, Regulatory Affairs will be responsible for overseeing regulatory activities related to clinical trials conducted by the... ...regulatory requirements and providing strategic regulatory guidance to internal teams and clients. The Sr. Manager, Regulatory Affairs will...
...evaluating project management system flows (Product Submissions) in internally used system.
Monitors the assigned new and emerging... ...drive engagement.
Highly motivated and experienced regulatory affairs professional
Comfortable working with different cultures and...
Maintain regular communication with government officials, keeping them updated on progress, addressing any concerns, and seeking their input and feedback.
Develop and manage trusted relationships with key influencers, Government officials, academia, industry peers and trade...
...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 and externally. You will work closely with internal personnel and...
...intellectual firepower.
Welcome to the relentless pursuit of better.
Inviting applications for the role of a Lead consultant, Regulatory Affairs Pharmaceutical
You should have minimum years of experience in regulatory affairs with must knowledge of current regulatory...
...Job Description
Job Description:
Role : Corporate Affairs Specialist
Level : T1
Location : Mumbai
Job Profile
Manages... ...and develops strategic counsel, support and supervision for the Internal & external corporate communication strategy, process and governance...
...Description :
Job Title:
Ideation Specialist (Medical Affairs)
Job Category:
Head Office Based Medical Affairs... ...Consultancy agencies, Regulatory authorities and other stakeholders
Internal Stakeholders
Medical advisors, Therapeutic area leads,...
...extensions (SKUs ).
Co-ordinate with the relevant customers (internal / external) for trigger / support to regulatory issues arising out... ..., RRL, HSM, HLM, GRRS team etc. ,
External Interaction: Government Health Authority, BoH, etc. ,
Regulatory Affairs
#LI-PFE
...Position Title - Regional Corporate Affairs Manager Location - Mumbai
Experience - 8-10 Yrs
Qualification - Any Bachelor / Master’s degree, Degree in Mass media and Communication or Public administration or Law, will be an added advantage.
Job Responsibilities...
Rs 2.4 - 4.2 lakhs p.a.
...help a company or organization meet all state, local, federal, international, and industrial regulations that apply to their products.
They... ..., often with competing priorities.
Most regulatory affairs positions are full time.
Regulatory Responsibility means...
...The Scientific & Regulatory Affairs (SRA) Manager, APAC, should be comfortable to travel between the two cities, as required
The ideal... ...and India
We are looking for an excellent communicator, both internally developing relationships with cross-functional business partners...
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...
...portfolio and make action plan for Implementation of the change.
About you
Experience : (8-12 years of experience in Regulatory Affairs, Quality Assurance)
Soft skills : Transversal skills, Stakeholders management, Effective communication with external partners and...