Specialist, RA Job at Baxter (Ahmedabad)

Specialist, RA

Aggregate Safety Report (PSUR/ PBRER/ PADER) related activity - Responsible to p...

Location

India , Ahmedabad

Salary:

Not provided

Baxter

Expiration Date

Until further notice

Requirements

Responsible to provide PV support for new submissions and Post approval activities for Pharma Segment
RFI Evaluation, Authoring Support activities (ASG) for PSUR/ PBRER/ PADER and ACO scheduling and submission
Review and preparation of PADER/ PSUR/ PBRER, coordination for their submission as per schedule
Handling of request received from central and local regulatory affairs and PV department with respect of timeline
Assist in developing RMP and allied activities
Coordinate with Global RMP team as well as in-house reg team to ensure RMPs are submitted as per their applicable dates
Assist in developing CO/NCO and allied activities
Coordinate with Global team as well as in-house reg team to ensure CO/NCOs are submitted as per their applicable dates
Designation of New RSI and CCDS /CCSI Generation
CCDS/ CCSI/ RSI Revision based on safety signals

Job Responsibility

Aggregate Safety Report (PSUR/ PBRER/ PADER) related activity
RMP Related activities
CO/ NCO Related activities
Signal management activities
The Extended EudraVigilance Medicinal Product Dictionary (XEVMPD) maintenance

Fulltime

Ra Specialist

Location

Australia

Salary:

Not provided

Product Life Group

Expiration Date

Until further notice

Requirements

Undergraduate qualifications in the pharmaceutical sciences or other scientific discipline
A minimum of 5 years’ experience in regulatory affairs, preferably in a commercial environment
English
Experience in the review, critical evaluation and presentation of data for medicine dossiers
Good knowledge of legislation, regulations, guidelines and working procedures within Australia, New Zealand and the JAPAC region
High level written and oral communication skills
Proven problem solving and project management skills
Reasonable computer literacy
Ability to deal with high level of confidentiality

Job Responsibility

Provide support to clients on the registration and listing of pharmaceuticals, biologicals and medical devices in Australia and New Zealand and (JAPAC) region
Provide support to clients with the maintenance of current registrations and listings
Review, critically evaluate, prepare and submit regulatory dossiers to the TGA and Medsafe
Act as Project Lead/Manager, participate in assigned projects and support project teams as requested
Assist clients in responding to TGA and Medsafe questions
Develop a subject matter expert area(s)
Assist in the preparation of literature-based submissions, including the preparation of associated overviews and summaries
Provide strategic advice to clients regarding the JAPAC regulatory environment
Preparation, review and update of quality documentation
Assist with development of proposals

Fulltime

Regulatory Affairs Specialist

A Specialist profile will ensure efficient project execution, better quality out...

Location

India

Salary:

Not provided

Product Life Group

Expiration Date

Until further notice

Requirements

Bachelor’s or higher degree in a science related field, or equivalent experience
7-8 years of EU RA technical and project management experience
Good English language and grammar skills (written fluency a must, verbal fluency preferred)
Good computer skills and the ability to learn appropriate software
Good understanding of regulatory tracking database software, MS Word, MS Excel, MS PowerPoint etc.
Excellent organizational and interpersonal skills
Ability to work well within a team

Job Responsibility

Contribute to regulatory activities performed on the RA Platform/the Hub
Regulatory activities include pre licensing activities, new registration (sites and medicinal products), post licensing regulatory submissions, interaction with health authorities on behalf of PLG customers
To contribute to the production of client administrative documents and reports to be included in regulatory submissions
Support for Initial MA application, all kind of LCM activities
Act as (Single) Point of Contact and oversee clients’ portfolios
Cross-functional co-ordination
Communication with external vendors
Communication/Co-ordination with client and participate in client’s meeting, preparing MoM etc
Compile, or supervise the compilation of regulatory dossiers in accordance with national requirements
Systems Management and Administration

Fulltime

Regulatory Affairs Officer

Contribute to regulatory activities performed on the RA Platform/the Hub. Regula...

Location

India

Salary:

Not provided

Product Life Group

Expiration Date

Until further notice

Requirements

Bachelor’s or higher degree in a science related field, or equivalent experience
4-6 years of experience in RA European Regulation
Good English language and grammar skills (written fluency a must, verbal fluency preferred)
Good computer skills and the ability to learn appropriate software
Good understanding of regulatory tracking database software, MS Word, MS Excel, MS PowerPoint etc.
Excellent organizational and interpersonal skills
Ability to work well within a team
Process orientated with good attention to detail

Job Responsibility

Contribute to regulatory activities performed on the RA Platform/the Hub
Regulatory activities include pre licensing activities, new registration (sites and medicinal products), post licensing regulatory submissions, interaction with health authorities on behalf of PLG customers
To contribute to the production of client administrative documents and reports to be included in regulatory submissions
Compile, or supervise the compilation of regulatory dossiers in accordance with national requirements
Systems Management and Administration
Document and track regulatory submissions and regulatory authority approval
Gain regulatory authority approval
Provide regulatory support to clients and associate companies
Liaise with sponsor head-office and affiliate departments on regulatory issues
Liaise with external regulatory authorities as required

Fulltime

Senior Regulatory Affairs Specialist

ICON plc is a world-leading healthcare intelligence and clinical research organi...

Location

South Korea , Seoul

Salary:

Not provided

iconplc

Expiration Date

Until further notice

Requirements

Degree in Pharmacy preferred
+3 years of experience in pharmaceutical, medical device or health industry
Experience in regulatory affairs or relevant discipline is preferred
Solid understanding of drug development
Good knowledge of National Drug Regulations and Procedures
English Proficiency
Good communication skill for external and internal interaction
Good computer literacy skills, comfortable working with database

Job Responsibility

Achieve timely & successful product registration in accordance with corporate & local strategies
Collect any information on new regulations and guidelines and share it in local RA team
Ensure compliance with company regulatory policies, regulations and procedures
Design and assess local regulatory plans including new strategic concepts and license opportunities and provide consolidated input on key regulatory development in cross-functional team meeting
Manage all regulatory tasks & projects including attaining, maintaining product licenses and operations licenses for assigned portfolio on behalf of company as required by local regulations
Prepare and submit regulatory applications for assigned portfolio and ensure timely approval
Develop local registration plans in alignment with local business and global regulatory strategy
Monitor progress of submission & coordinate timely responses to all questions from health authorities
Be compliant with Corporate Policies, Regulations & Procedures, in particular implementation of current Company Core Data Sheet (CCDS), Change Review Committee (CRC) and local change control procedures
Management of regulatory submissions to support clinical trial activities

What we offer

Various annual leave entitlements
A range of health insurance offerings to suit you and your family's needs
Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead
Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family's well-being
Life assurance
Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others

Fulltime

Regulatory Affairs Specialist/Senior Specialist

We are looking for a new regulatory colleague for our life cycle management (LCM...

Location

Denmark , København

Salary:

Not provided

Life Science Talent

Expiration Date

Until further notice

Requirements

University degree on relevant field e.g pharmaceutical or life sciences
Preferably 1-5 years of experience from a position in regulatory affairs, but with the right personal competences a newly graduated could also be a match
Proactive, a team player, systematic and can establish and discuss a regulatory approach including risks and benefits for life-cycle management activities
Strong communication skills, written and verbally
Mother tongue in either Danish, Swedish or Norwegian and English both verbal and written
Technical flair – e.g. experience/interest in working with (EDMS) Electronic Document Management System, (RIMS) Regulatory Information management System or the like.

Job Responsibility

Responsible for all life cycle management activities for own defined portfolio
Regulatory compliance of marketing authorizations
Quality (CMC) documentation and safety updates/text management, prepare and ensure timely submission for products in the Nordics
Respond to requests from the health authorities as well as being responsible for providing approved texts for implementation in due time
Close collaboration with Supply Chain/Planning/QA/QC and commercial teams as well as Global RA with focus on business partnership
Act as an expert, ensuring compliance with regulatory guidelines, provide guidance on national and EU legislation within the regulatory field
Regulatory handling of change controls and deviations in GxP validated IT System

What we offer

Competitive salary and Bonus based on personal and company results
Pension Scheme
Health Insurance
Flexible working conditions with hybrid working policy
Employee recognition scheme
Development both professionally and personally
Learning about company processes

Fulltime

Regulatory Affairs Specialist

Regulatory Affairs - office based - Bogota. ICON plc is a world-leading healthca...

Location

Colombia , Bogota

Salary:

Not provided

iconplc

Expiration Date

Until further notice

Requirements

Bachelor's degree in Pharmaceutical Chemist or next to graduate required
Minimum 1 year of experience in regulatory area within the pharmaceutical or biotechnology industry
Knowledge or awareness of current regional guidelines and regulations is preferred
Technical knowledge in the preparation of a dossier is desirable
Prior experience using computerized information systems required: PC Windows, word processing and electronic spreadsheets
Advanced English level

Job Responsibility

Manage activities associated with obtaining initial, amendment and other central authority approvals i.e. Regulatory Agency (RA), and any other central authorities for the assigned country/ countries
Perform submission and maintenance of new health records, renovations and modifications to keep the products on the market according to the strategic plan established by the company, current Colombian laws and current local health legislation in accordance with the corporate guidelines and policies, procedures and premises
Review of promotional materials for products for human use of their therapeutic line(s) in Veeva Vault or current tool
Perform submission and monitoring of products for human use of their therapeutic line(s) in procedures such as: PSUR, DSUR, RMPs, and safety information according to current Colombian regulations
Back-up to the Head of Regulatory Affairs and analysts of records in the procedures of INVIMA in order to guarantee the operation of the area
Ensure that IP labels are in adherence to country requirements and submitted where applicable
Support the senior level regulatory staff/country consultant in the maintenance of accurate, up-to date Country Knowledge repositor
Contribute to the maintenance and collection of regulatory intelligence by ensuring that tools such as the Country Knowledge Repository and the Country Fact Sheets are up-to-date and communicate new information or changes to the Regulatory Intelligence Consultant team
Preparation of electronic regulatory submission of post-registration requests, HMPs, Labeling notifications, additions, publication corrections and database corrections, among other petitions to be field at MoH
Follow-up on the status of the regulatory submissions (paper dossiers) from dispatch to the receipt of proof of protocol

What we offer

Various annual leave entitlements
A range of health insurance offerings to suit you and your family’s needs
Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead
Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well-being
Life assurance
Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others

Fulltime

Regulatory Specialist II

Location

United States , Burnsville

Salary:

80000.00 - 110000.00 USD / Year

Imricor Medical Systems

Expiration Date

Until further notice

Requirements

Bachelor of Science in a scientific discipline or equivalent education/ training
2-4 years’ regulatory related experience in a regulatory industry. Additional education may be substituted for years of experience
Demonstrated ability to communicate complex ideas clearly and simply both orally and in writing
Skills in multiple computer-based tools and software such as Word, PowerPoint, Excel, and Adobe Acrobat
Must be able to work independently under limited supervision

Job Responsibility

Supports domestic and international strategies for regulatory approval of company products
Assists in coordination, compilation and submission of U.S. and international regulatory filings for new and modified products, including PMAs, 510(k)s, IDEs, CE Marking submissions, and other country specific product registrations
Reviews product and manufacturing changes for compliance with applicable regulations and impact to regulatory filings
Represents RA on cross functional product development, manufacturing and clinical support teams and provide regulatory feedback and guidance throughout the product development cycle
Completes technical and labeling reviews of supporting documents for inclusion in regulatory filings
Represents RA on other cross functional projects which may include process changes and continuous improvement efforts
Performs other related duties and responsibilities, as assigned

What we offer

Medical
Dental
Vision
Health Savings Accounts
Health Care & Dependent Care Flexible Spending Accounts
Disability Benefits
Life Insurance
Retirement Benefits

Fulltime

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