2 New Messages
Digest #3162
Messages
Tue Jan 7, 2014 4:49 pm (PST) . Posted by:
"Edith Paul"
Please contact the recruiter directly if you are interested.
Thank you.
---------- Forwarded message ----------
From: Hansle Guichardo <hans@protechpharma.com>
Date: Tue, Jan 7, 2014 at 6:21 PM
Subject: Sr. Manager and Sr. Specialist, Reg. Affairs in Rhode Island
To: paul.edith@gmail.com
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*Dear Edith,* *The positions below may not be a match to your
background, however; I'd like to know if you can forward these Regulatory
Affairs positions to other candidates that are searching for new
challenging opportunities. *
A growing pharmaceutical company located in *Rhode Island* is searching for
a
*SR. MANAGER and a SR. SPECIALIST in REGULATORY AFFAIRS.*
The performance bonus for the Sr. Manager is between 18-22%. The bonus for
the
Sr. Specialist is between 10-15%.
The company offers full relocation assistance, including a home purchase
program(as long as your house is in good standing, they will buy it out).
Salary is commensurate with experience plus 3 weeks vacation and a week of
shutdown during Christmas plus paid holidays, plus excellent company
benefits including 401K match, etc.
If you are in Regulatory Affairs and have the experience that my client is
searching for, then please contact me at 973-850-5149 or email me at
hans@protechpharma.com (word format resumes only, PDF's are not accepted)
Feel free to share these two exciting opportunities with other candidates
in the industry.
*SR. MANAGER, REGULATORY AFFAIRS*
Management experience is required for this position
CMC filing experience is required
In conduction with Regulatory Affairs experience, knowledge of chemistry is
ideal.
Knowledge of international RA regulations is ideal
Responsible for compiling and reviewing data for regulatory submissions
covering the company's products.
PRINCIPAL ACCOUNTABILITIES:
- Prepare, compile and publish regulatory submissions
- Track/update regulatory submissions in US and foreign countries
- Respond to customer inquiries in support of their regulatory filings
- Provide regulatory guidance and support to effected company's departments
- Review change controls for any possible regulatory impact
Job Requirements
Minimum Bachelor degree in science preferably PhD in organic chemistry.
Two years experience with US CMC filings. Familiarity with foreign filing
requirements desirable.
Required Experience & Technical Requirements
- Knowledge of CMC (Chemistry, Manufacturing & Controls) requirements for
Active Pharmaceutical Ingredients (APIs) - required for Drug Master Files
and providing support information to NDA/ANDA sponsors.
- Knowledge of chemistry (especially Organic Chemistry) to understand
complex chemical reactions and review and approve internal regulatory
documents (e.g. Development Reports, Validation Protocols, Investigations).
- Knowledge of FDA Regulatory Requirements relating to Facility
Registration, Drug Listing and DMFs - responsibility for updating and
tracking various filings and registrations. Eventual responsibility for
updating and tracking foreign filings.
- Must possess analytical skills and be detail oriented.
*SR. SPECIALIST, REGULATORY AFFAIRS*
Submission of IND, NDA and ANDA is required
eCTD experience is required
CMC experience is ideal
This position will have advanced responsibilities in support of the
Regulatory Affairs department goals and objectives.
PRINCIPAL ACCOUNTABILITIES:
- Manage regulatory affairs drug product development projects through
entire lifecycle - from initiation through commercialization.
- Review drug product labeling components for NDAs and ANDAs.
- Compose, review, and submit to the FDA original INDs, NDAs, ANDAs,
supplements, amendments, annual reports, and periodic adverse event reports
in both paper and electronic CTD format. Review all chemistry,
manufacturing, and controls (CMC) documentation related to submissions.
- Complete electronic publishing of regulatory submissions for submission
to the FDA and other regulatory authorities.
- Serve as the regulatory representative on cross-functional teams
supporting products throughout the stages of development and
commercialization. Ensure regulatory and cross-functional project
strategies and submission timelines are in alignment.
- Develop and track regulatory project timelines that incorporate all
submission requirements including CMC, clinical, and labeling functions.
- Communicate regulatory requirements and expectations to various contract
organizations, including travel for on-site meetings as necessary.
- Serve as the company's representative for industry groups. As needed,
travel to face-to-face meetings and communicate decision points and meeting
outcomes to senior management.
- Evaluate proposed changes to approved products for potential regulatory
impact. Gather required data as needed to defend regulatory filing
strategy.
- Contact FDA and other regulatory authorities for review status updates
for pending applications and supplements.
- Author and review departmental SOPs, as well as any additional SOPs that
may impact regulatory affairs.
- Monitor various websites and publications to gather regulatory
intelligence on proposed product pipeline projects and any associated
information.
- Perform due diligence audits of applications proposed for transfer from
external partners. Review all documentation submitted throughout the
lifecycle of the application and request any additional information prior
to authorization of the transfer.
Job Requirements
- BS in science or related field with 10 or more years of applicable US
Generic Drug Regulatory Affairs experience.
- Advanced degree preferred.
- US Regulatory Affairs Professional Certification is desirable.
Required Experience & Technical Requirements
- Experience filing electronic CTD submissions in the US
- Experience with regulatory timeline development and document tracking
- Excellent verbal and written communication skills
- Availability and willingness to travel as necessary
Hansle Guichardo
Sr. Recruiter
ProtechPharma Staffing LLC
www.protechpharma.com<http://r20.rs6.net/tn.jsp?e=001sJdAAHQUQ2qh9kFNlZ1UaGPP1Ywy20ceye5Dk93Cf1AYcikLYd-dPh4HkYYPe3F6Pryfm24UUDlDnd8-RQKg__u2NgumkMESIEClrT2Arc1PRKFbGnq-e5yEavvnuz33>
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ProtechPharma Staffing LLC | 45 Carey Avenue | Suite 105 | Butler | NJ |
07405
Thank you.
---------- Forwarded message ----------
From: Hansle Guichardo <hans@protechpharma.
Date: Tue, Jan 7, 2014 at 6:21 PM
Subject: Sr. Manager and Sr. Specialist, Reg. Affairs in Rhode Island
To: paul.edith@gmail.
Having trouble viewing this email? Click here
<http://campaign.
<http://s.rs6.
*Dear Edith,* *The positions below may not be a match to your
background, however; I'd like to know if you can forward these Regulatory
Affairs positions to other candidates that are searching for new
challenging opportunities. *
A growing pharmaceutical company located in *Rhode Island* is searching for
a
*SR. MANAGER and a SR. SPECIALIST in REGULATORY AFFAIRS.*
The performance bonus for the Sr. Manager is between 18-22%. The bonus for
the
Sr. Specialist is between 10-15%.
The company offers full relocation assistance, including a home purchase
program(as long as your house is in good standing, they will buy it out).
Salary is commensurate with experience plus 3 weeks vacation and a week of
shutdown during Christmas plus paid holidays, plus excellent company
benefits including 401K match, etc.
If you are in Regulatory Affairs and have the experience that my client is
searching for, then please contact me at 973-850-5149 or email me at
hans@protechpharma.
Feel free to share these two exciting opportunities with other candidates
in the industry.
*SR. MANAGER, REGULATORY AFFAIRS*
Management experience is required for this position
CMC filing experience is required
In conduction with Regulatory Affairs experience, knowledge of chemistry is
ideal.
Knowledge of international RA regulations is ideal
Responsible for compiling and reviewing data for regulatory submissions
covering the company'
PRINCIPAL ACCOUNTABILITIES:
- Prepare, compile and publish regulatory submissions
- Track/update regulatory submissions in US and foreign countries
- Respond to customer inquiries in support of their regulatory filings
- Provide regulatory guidance and support to effected company'
- Review change controls for any possible regulatory impact
Job Requirements
Minimum Bachelor degree in science preferably PhD in organic chemistry.
Two years experience with US CMC filings. Familiarity with foreign filing
requirements desirable.
Required Experience & Technical Requirements
- Knowledge of CMC (Chemistry, Manufacturing & Controls) requirements for
Active Pharmaceutical Ingredients (APIs) - required for Drug Master Files
and providing support information to NDA/ANDA sponsors.
- Knowledge of chemistry (especially Organic Chemistry) to understand
complex chemical reactions and review and approve internal regulatory
documents (e.g. Development Reports, Validation Protocols, Investigations)
- Knowledge of FDA Regulatory Requirements relating to Facility
Registration, Drug Listing and DMFs - responsibility for updating and
tracking various filings and registrations. Eventual responsibility for
updating and tracking foreign filings.
- Must possess analytical skills and be detail oriented.
*SR. SPECIALIST, REGULATORY AFFAIRS*
Submission of IND, NDA and ANDA is required
eCTD experience is required
CMC experience is ideal
This position will have advanced responsibilities in support of the
Regulatory Affairs department goals and objectives.
PRINCIPAL ACCOUNTABILITIES:
- Manage regulatory affairs drug product development projects through
entire lifecycle - from initiation through commercialization.
- Review drug product labeling components for NDAs and ANDAs.
- Compose, review, and submit to the FDA original INDs, NDAs, ANDAs,
supplements, amendments, annual reports, and periodic adverse event reports
in both paper and electronic CTD format. Review all chemistry,
manufacturing, and controls (CMC) documentation related to submissions.
- Complete electronic publishing of regulatory submissions for submission
to the FDA and other regulatory authorities.
- Serve as the regulatory representative on cross-functional teams
supporting products throughout the stages of development and
commercialization. Ensure regulatory and cross-functional project
strategies and submission timelines are in alignment.
- Develop and track regulatory project timelines that incorporate all
submission requirements including CMC, clinical, and labeling functions.
- Communicate regulatory requirements and expectations to various contract
organizations, including travel for on-site meetings as necessary.
- Serve as the company'
travel to face-to-face meetings and communicate decision points and meeting
outcomes to senior management.
- Evaluate proposed changes to approved products for potential regulatory
impact. Gather required data as needed to defend regulatory filing
strategy.
- Contact FDA and other regulatory authorities for review status updates
for pending applications and supplements.
- Author and review departmental SOPs, as well as any additional SOPs that
may impact regulatory affairs.
- Monitor various websites and publications to gather regulatory
intelligence on proposed product pipeline projects and any associated
information.
- Perform due diligence audits of applications proposed for transfer from
external partners. Review all documentation submitted throughout the
lifecycle of the application and request any additional information prior
to authorization of the transfer.
Job Requirements
- BS in science or related field with 10 or more years of applicable US
Generic Drug Regulatory Affairs experience.
- Advanced degree preferred.
- US Regulatory Affairs Professional Certification is desirable.
Required Experience & Technical Requirements
- Experience filing electronic CTD submissions in the US
- Experience with regulatory timeline development and document tracking
- Excellent verbal and written communication skills
- Availability and willingness to travel as necessary
Hansle Guichardo
Sr. Recruiter
ProtechPharma Staffing LLC
www.protechpharma.
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ProtechPharma Staffing LLC | 45 Carey Avenue | Suite 105 | Butler | NJ |
07405
Tue Jan 7, 2014 7:32 pm (PST) . Posted by:
"Alicja Lisnow" a_lisnow
NNJ ASTD - Career
Transition SIG – 01.09.14 - 7–9 PM. Communication By The Numbers!
https://astd19.eventbrite.com/
Speaker: Cynthia Clark, Career
Quest Coaching, Inc., www.cynthiaclarkconsulting.com
Program Agenda:
6:30-7:00 Registration/Check-in - Peer Resume Review
7:00-7:30 Career Transition SIG/
Introductions/Other
7:30-8:45 Program Presentation
8:45-9:00 Questions/Networking
Location: Cedar Hill Christian Reformed Church 422 Cedar Hill Ave, Wyckoff,
NJ 07481-2219, Park in
the back, entrance on the right.
Contact: Alicja Lisnow (SIG Chair): a_lisnow@yahoo.com
Everyone is welcome to attend.
The Northern NJ ASTD Career Transition SIG provides a
professional forum for participants seeking new career
opportunities in various professions. Many members of the SIG group are
professionals in Training and Development.
The SIG's goal is to provide space for networking, exchange of
resources, contacts, information, mutual support and learning,and job leads for those seeking new career opportunities.
Registration & Details: https://astd19.eventbrite.com/ or http://nnjastd.org
Alicja Lisnow, MSET
Training / Healthcare / Technology / Sales Operations / Client Services
A_Lisnow@Yahoo.com / 201.519.0545
LinkedIn /BCNC/ NNJASTD Career Transition / MSET Portfolio
Transition SIG – 01.09.14 - 7–9 PM. Communication By The Numbers!
https://astd19.
Speaker: Cynthia Clark, Career
Quest Coaching, Inc., www.cynthiaclarkcon
Program Agenda:
6:30-7:00 Registration/
7:00-7:30 Career Transition SIG/
Introductions/
7:30-8:45 Program Presentation
8:45-9:00 Questions/Networkin
Location: Cedar Hill Christian Reformed Church 422 Cedar Hill Ave, Wyckoff,
NJ 07481-2219, Park in
the back, entrance on the right.
Contact: Alicja Lisnow (SIG Chair): a_lisnow@yahoo.
Everyone is welcome to attend.
The Northern NJ ASTD Career Transition SIG provides a
professional forum for participants seeking new career
opportunities in various professions. Many members of the SIG group are
professionals in Training and Development.
The SIG's goal is to provide space for networking, exchange of
resources, contacts, information, mutual support and learning,and job leads for those seeking new career opportunities.
Registration & Details: https://astd19.
Alicja Lisnow, MSET
Training / Healthcare / Technology / Sales Operations / Client Services
A_Lisnow@Yahoo.
LinkedIn /BCNC
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