NOC for regulatory affairs_pharmaceuticals

[raj_sttud]

Hello Everyone,

My name is Rajesh and I have joined this forum recently.

I plan to apply for a Canadian PR under Express Entry option. However, narrowing down on the best possible NOC match is getting a bit confusing.
I have a total of 7 years experience in Regulatory Affairs for Pharmaceutical products.
I humbly request any member with Regulatory Affairs background to please share what NOC did they go for? And did the letter reference need any tweaking around?
I am asking this since the roles and responsibilities of Regulatory Affairs profession are same across the world.

Hope to hear from you guys soon.

Regards,
Rajesh Gurjar

 

[istari]

Hello Everyone,

My name is Rajesh and I have joined this forum recently.

I plan to apply for a Canadian PR under Express Entry option. However, narrowing down on the best possible NOC match is getting a bit confusing.
I have a total of 7 years experience in Regulatory Affairs for Pharmaceutical products.
I humbly request any member with Regulatory Affairs background to please share what NOC did they go for? And did the letter reference need any tweaking around?
I am asking this since the roles and responsibilities of Regulatory Affairs profession are same across the world.

Hope to hear from you guys soon.

Regards,
Rajesh Gurjar

If you're unsure of you NOC, email a list of your duties to noc@workingincanada.gc.ca and they will tell you the correct NOC.

 

[raj_sttud]

Hi istari,

Thank for the suggestion. However, I have already tried that and the Agency reverted with options "2112" or "3131".
Now, the catch is that, unless the CIC reviewer has an understanding of the Regulatory Affairs profession, there are high chances my application may be rejected since on paper my roles and responsibilities don't match either 2112 or 3131.
That is reason I reaching out to any fellow forum member who applied under 3131 with a Regulatory Affairs background.

 

[MZASAM]

Raj_sttud,

Tried my best with OINP to get the appropriate NOC for one of my relative who is a RA professional. OINP could not provide NOC

Summary of my educational qualifications and experience.

Masters Degree: Master of Science in Pharmaceutical Sciences
University of Greenwich, Kent, United Kingdom (UK) 2008 – 2010 Merit First Class

Modules: Pharmaceutical Analysis, Medicinal Chemistry, Pharmaceutics, Microbiology and Biotechnology.
Bachelors Degree: Pharmacy

Jawaharlal Nehru Technology University, Hyderabad, 2004 – 2008 First Class
Modules: Pharmaceutics, Organic Chemistry, Pharmacology, Pharmaceutical Analysis, Pharmacognosy,
Microbiology and Industrial Pharmacy along with Industrial Training.

I. Roles and Responsibilities :
Report level Publishing of CSRs, IBs, PSMF, RMP, PV reports PSUR, SUSAR, SAR, DSUR, CMC documents using Liquent Insight Publisher and ISI Tool box
Leading Offshore team, Coordinating with onshore team and managing the work load to meet the quality and time lines. Single point of Contact for Client.
Attending meetings with Clients, Medical writers
Provide in house training's and mentoring support
Additional Roles and Responsibilities:

Publishing, building structure, compilation, quality performance, validations of dossiers eCTD & NeeS
Original Submissions and Life cycle maintenance of dossier.
Create and verify bookmark structure and hyperlinks, coordinator to find, resolve submission issues.
Quality, Archival Check of submissions.
Computer based training's and exercise practice conducted by client.
Perform document level and final quality control reviews of submission PDF files.
Create and verify bookmark structure and hyperlinks to ensure submission readiness.
Organize folders/ files to build electronic submissions.
Participate in the development of large scale internal projects.

II. Roles and Responsibilities :
· Responsible for monitoring the conduct of clinical research studies.
· Assess the qualification of potential investigative sites, initiate studies, instruct site personnel on the proper conduct of studies.
· To review and ensure data collected from start up until termination of studies.
· Implement and monitor clinical trials to ensure sponsor and investigator obligations are being met
and compliant with applicable local regulatory requirements and ICH guidelines.
· Perform investigative site file reconciliation, request any new or updated site-related essential and
Non-essential documents and reviews them for content, consistency with other documents with appropriate local regulatory requirements,
ICH guidelines, project SOPs and sponsor requirements.
· Perform source document verification, retrieve case report forms (CRFs) and perform query
resolution in a timely manner and oversee drug accountability and safety at investigative sites.
· Ensure Serious Adverse Event (SAE) reporting according to project specifications, review SAE
information, resolve queries and assist sites in completion of SAE reports.
· Creating accurate and user-friendly study documentation from knowledge and understanding of the
Protocol, standardized formats, software applications and SOPs.
· Generate reports for site and project management.

III. Roles and Responsibilities :
· CRF designing elements, paper based CRF designing, data entry, remote data entry, electronic data capture (EDC) e-CRF designing,
data quality management and data validation.
· Oracle Clinical, Openclinica - Role based access as monitor, Data manager, Openclinica- Study creation and designing.
· Edit check writing and designing CRF for phase II, III and IV studies, Bio-Equivalent studies, and ICH-GCP and data management
operating procedures.
· Data validation processes like discrepancy review, DCF life cycle etc, including QC and Serious Adverse Event (SAE) reconciliation process.
· Knowledge on project finance, project utilization, project management, and project realization.




Good day,

Thank you for your interest in the NOC.

Based on the limited information you have provided, we are unable to propose a potential National Occupational Classification (NOC) code. Please conduct a more thorough search in the NOC Web site by using your occupational title or keywords related to your profession in the Quick Search box located at the top left side of the menu bar. This will generate a list of possible occupations. The education, main duties and employment requirements should also correspond to your occupation.

In order for us to provide you with a potential NOC code, we require the following additional information about the occupation:

- the exact job title;
- a detailed description of the main duties;
- the education and work experience required by the employer for entry into the occupation; and
- the type of establishment in which the work is performed.

For reasons of security and privacy do not send any documentation electronically, such as resumes and government-issued case numbers or hyperlinks or attachments.

Note that the final decision for selecting the most appropriate National Occupational Classification (NOC) code is each individual's responsibility as you know your education, skills and abilities better than anyone else.

 

[MZASAM]

In order for us to provide you with a potential NOC code, we require the following additional information about the occupation:

- the exact job title;
- a detailed description of the main duties;
- the education and work experience required by the employer for entry into the occupation; and
- the type of establishment in which the work is performed.

We provided all the above info; no response.

Try your luck

 

[gprasadh84]

Hi,

Just noticed that there has been updates to the NOC structure. Code 1122 lists example titles of:
regulatory affairs analyst
regulatory affairs associate
regulatory affairs officer
regulatory affairs specialist

Some points in the job description seem to match that of a regulatory professional :

Conduct assessments and propose improvements to methods, systems and procedures in areas such as operations, human resources, records management and communications
Conduct quality audits and develop quality management and quality assurance standards for ISO (International Organization for Standardization) registration
Provide guidance and support to business on regulatory policies and procedures; ensure internal compliance with regulatory requirements; prepare submissions and filings with regulatory bodies

Any inputs on this from anyone in this discussion?

Thanks!

Hello Everyone,

My name is Rajesh and I have joined this forum recently.

I plan to apply for a Canadian PR under Express Entry option. However, narrowing down on the best possible NOC match is getting a bit confusing.
I have a total of 7 years experience in Regulatory Affairs for Pharmaceutical products.
I humbly request any member with Regulatory Affairs background to please share what NOC did they go for? And did the letter reference need any tweaking around?
I am asking this since the roles and responsibilities of Regulatory Affairs profession are same across the world.

Hope to hear from you guys soon.

Regards,
Rajesh Gurjar

 

[ashishshirke21]

Hi Rajesh,

I am also working in regulatory affairs. Please let me know which NOC you will be using.

Thanks

 

[Bdrm]

Hi

I am also looking for the noc code for regulatory affairs in pharma. Will Noc 3131 be considered acceptable since I hardly see any duties related to regulatory mentioned in there.

 

[nzlak]

was anyone able to find correct code ?

 

[NidhiCB]

Hi,

Just noticed that there has been updates to the NOC structure. Code 1122 lists example titles of:
regulatory affairs analyst
regulatory affairs associate
regulatory affairs officer
regulatory affairs specialist

Some points in the job description seem to match that of a regulatory professional :

Conduct assessments and propose improvements to methods, systems and procedures in areas such as operations, human resources, records management and communications
Conduct quality audits and develop quality management and quality assurance standards for ISO (International Organization for Standardization) registration
Provide guidance and support to business on regulatory policies and procedures; ensure internal compliance with regulatory requirements; prepare submissions and filings with regulatory bodies

Any inputs on this from anyone in this discussion?

Thanks!

Hi. I based my NOC on this too. I'm a medical devices regulatory and quality specialist. However, I cant see this description in the current NOC list. I've already submitted my application post ITA. Seniors, any thoughts on how to handle this?

 

[Pushpasree]

Hi,

Just noticed that there has been updates to the NOC structure. Code 1122 lists example titles of:
regulatory affairs analyst
regulatory affairs associate
regulatory affairs officer
regulatory affairs specialist

Some points in the job description seem to match that of a regulatory professional :

Conduct assessments and propose improvements to methods, systems and procedures in areas such as operations, human resources, records management and communications
Conduct quality audits and develop quality management and quality assurance standards for ISO (International Organization for Standardization) registration
Provide guidance and support to business on regulatory policies and procedures; ensure internal compliance with regulatory requirements; prepare submissions and filings with regulatory bodies

Any inputs on this from anyone in this discussion?

Thanks!

Hi gprasadh,
I checked the code 1122 that you have mentioned, but I am afraid i could not find any titles for Regulatory affairs. Could you please tell me where you found these updates.

Thanks,
Pushpasree

 

[np2017]

Raj_sttud,

Tried my best with OINP to get the appropriate NOC for one of my relative who is a RA professional. OINP could not provide NOC

Summary of my educational qualifications and experience.

Masters Degree: Master of Science in Pharmaceutical Sciences
University of Greenwich, Kent, United Kingdom (UK) 2008 – 2010 Merit First Class

Modules: Pharmaceutical Analysis, Medicinal Chemistry, Pharmaceutics, Microbiology and Biotechnology.
Bachelors Degree: Pharmacy

Jawaharlal Nehru Technology University, Hyderabad, 2004 – 2008 First Class
Modules: Pharmaceutics, Organic Chemistry, Pharmacology, Pharmaceutical Analysis, Pharmacognosy,
Microbiology and Industrial Pharmacy along with Industrial Training.

I. Roles and Responsibilities :
Report level Publishing of CSRs, IBs, PSMF, RMP, PV reports PSUR, SUSAR, SAR, DSUR, CMC documents using Liquent Insight Publisher and ISI Tool box
Leading Offshore team, Coordinating with onshore team and managing the work load to meet the quality and time lines. Single point of Contact for Client.
Attending meetings with Clients, Medical writers
Provide in house training's and mentoring support
Additional Roles and Responsibilities:

Publishing, building structure, compilation, quality performance, validations of dossiers eCTD & NeeS
Original Submissions and Life cycle maintenance of dossier.
Create and verify bookmark structure and hyperlinks, coordinator to find, resolve submission issues.
Quality, Archival Check of submissions.
Computer based training's and exercise practice conducted by client.
Perform document level and final quality control reviews of submission PDF files.
Create and verify bookmark structure and hyperlinks to ensure submission readiness.
Organize folders/ files to build electronic submissions.
Participate in the development of large scale internal projects.

II. Roles and Responsibilities :
· Responsible for monitoring the conduct of clinical research studies.
· Assess the qualification of potential investigative sites, initiate studies, instruct site personnel on the proper conduct of studies.
· To review and ensure data collected from start up until termination of studies.
· Implement and monitor clinical trials to ensure sponsor and investigator obligations are being met
and compliant with applicable local regulatory requirements and ICH guidelines.
· Perform investigative site file reconciliation, request any new or updated site-related essential and
Non-essential documents and reviews them for content, consistency with other documents with appropriate local regulatory requirements,
ICH guidelines, project SOPs and sponsor requirements.
· Perform source document verification, retrieve case report forms (CRFs) and perform query
resolution in a timely manner and oversee drug accountability and safety at investigative sites.
· Ensure Serious Adverse Event (SAE) reporting according to project specifications, review SAE
information, resolve queries and assist sites in completion of SAE reports.
· Creating accurate and user-friendly study documentation from knowledge and understanding of the
Protocol, standardized formats, software applications and SOPs.
· Generate reports for site and project management.

III. Roles and Responsibilities :
· CRF designing elements, paper based CRF designing, data entry, remote data entry, electronic data capture (EDC) e-CRF designing,
data quality management and data validation.
· Oracle Clinical, Openclinica - Role based access as monitor, Data manager, Openclinica- Study creation and designing.
· Edit check writing and designing CRF for phase II, III and IV studies, Bio-Equivalent studies, and ICH-GCP and data management
operating procedures.
· Data validation processes like discrepancy review, DCF life cycle etc, including QC and Serious Adverse Event (SAE) reconciliation process.
· Knowledge on project finance, project utilization, project management, and project realization.




Good day,

Thank you for your interest in the NOC.

Based on the limited information you have provided, we are unable to propose a potential National Occupational Classification (NOC) code. Please conduct a more thorough search in the NOC Web site by using your occupational title or keywords related to your profession in the Quick Search box located at the top left side of the menu bar. This will generate a list of possible occupations. The education, main duties and employment requirements should also correspond to your occupation.

In order for us to provide you with a potential NOC code, we require the following additional information about the occupation:

- the exact job title;
- a detailed description of the main duties;
- the education and work experience required by the employer for entry into the occupation; and
- the type of establishment in which the work is performed.

For reasons of security and privacy do not send any documentation electronically, such as resumes and government-issued case numbers or hyperlinks or attachments.

Note that the final decision for selecting the most appropriate National Occupational Classification (NOC) code is each individual's responsibility as you know your education, skills and abilities better than anyone else.

Hi, What NOC code did you use then for filing your application? I have similar experience. Thanks

 

[anj_guru]

Hi gprasadh,
I checked the code 1122 that you have mentioned, but I am afraid i could not find any titles for Regulatory affairs. Could you please tell me where you found these updates.

Thanks,
Pushpasree

NOC 1122 is present in the NOC 2016 classification. However, CIC uses NOC 2011 classification, which does not list Regulatory Affairs under 1122.

I worked as a Regulatory Associate and used the code 4165. I had the reference letters from both my companies with certain duties and responsibilities that matched 4165. I strongly suggest to check with your duties and responsibilities. Ultimately, the reference letter and NOC should fairly match.

Thanks.

 

[abdulaleemuddin]

NOC 1122 is present in the NOC 2016 classification. However, CIC uses NOC 2011 classification, which does not list Regulatory Affairs under 1122.

I worked as a Regulatory Associate and used the code 4165. I had the reference letters from both my companies with certain duties and responsibilities that matched 4165. I strongly suggest to check with your duties and responsibilities. Ultimately, the reference letter and NOC should fairly match.

Thanks.

have u tried NOC 4165 for immgration , what is your status of application

 

[anj_guru]

have u tried NOC 4165 for immgration , what is your status of application

Yes, I applied with 4165. I am currently in Canada as a Permanent resident. Again, please check if the NOC matches the job description. It differs on a case by case basis.