Month Contract
JOB DESCRIPTION
On behalf of our client, a global pharmaceutical company, we are
currently recruiting for a Regulatory Officer Submissions This is a
**Apply on the website** month contract, full-time role.
OBJECTIVES
* Ensure timely preparation and compilation of registration dossier
components in accordance to EU or relevant Health Authority standards,
and corporate requirements
* Under supervision of the senior RA person (if required), manage
international regulatory submissions according to company strategy and
ensure registration deadlines are met
* Responding to Health Authorities&#**Apply on the website**;
queries and deficiencies in a timely manner
* Liaise with other departments to support the timely introduction
of new product into markets
* Maintain assigned products&#**Apply on the website**; Marketing
Authorisations via submission of the appropriate variations and
renewals in a timely manner
* Communication of Health Authority approvals/final decisions to the
relevant departments
* Build departmental awareness of local regulatory requirements in
relevant markets
* Compile regulatory components of annual product quality review
(PQR) and PSUR/PBER
DUTIES
DOSSIER MANAGEMENT
* TASKS RELATED TO THE RA PLAN
* Under supervision of the senior RA person (if required), submit
Marketing Authorisation Applications (MAAs) to Health Authorities
according to the registration plan and company&#**Apply on the
website**;s registration strategy.
* Proactively inform RA Manager and other involved functions
regarding all identified risks related to the planned MAA.
* Support the process of Scientific Advice from Health Authorities
by liaising with the relevant Authority and preparing the necessary
documents. COMPILATION OF REGISTRATION DOSSIERS FOR IDENTIFIED
COUNTRIES Review of registration dossier components for accuracy,
completeness and compliance with EU or relevant Health Authority
regulations and relevant guidelines; ensure that all specific national
requirements are met.Identify deficiencies and risks associated with
dossier quality and consult it with senior RA person and/or RA
Manager.Raise all identified risks related to the quality of the
dossier in order to meet submission deadlines, without a compromise in
the quality of the submission. SUBMISSION AND REGISTRATION PROCESS
Prepare, as per internal SOP, the data needed to make all required
registration fees in a timely manner.Dispatch the documentation in the
appropriate manner in order to deliver it to the relevant Health
Authority or local Regulatory Service Provider or local Marketing
Authorisation Holder (MAH.Answer all queries received from Health
Authorities during the validation phase of registration.Ensure all
internal RA databases are updated with any new specific national
requirements.Address all deficiencies identified by the Health
Authority in an appropriate manner within the required timelines.
During the Response to Questions preparation liaise closely with
internal/external contacts, relevant departmental staff and Health
Authorities to ensure efficient and timeous product
registration.Consult with senior RA person during RtQ document
preparation.Communicate any change in status for assigned tasks. Raise
all identified risks related to the deficiencies from Health
Authorities which might cause negative decision of procedure or delays
in timelines. MAINTAIN THE ASSIGNED PRODUCTS? MARKETING
AUTHORISATIONS IN TERRITORY Under senior RA person supervision (if
required), review MAs in accordance with registration requirements and
track change controls according to internal processes.Review, prepare
and compile the registration documentation required to maintain MAs,
for example variations (required internally or requested by Regulatory
Authorities), any supplements to dossiers, notification, renewals.
REGULATORY GOOD PRACTICE Perform assigned work according to current
good regulatory practice and in compliance with current legislation
and regulatory guidelines at all times.Ensure that any regulatory
changes communicated to the pharmaceutical industry by Regulatory
Authorities are raised to the RA Manager in order to implement them
without delay within the relevant department.
REQUIREMENTS
* Life sciences (BSc in Chemistry/ Biology, etc.) or pharmacy degree
* Experience in a regulatory affairs environment required
* Experience in the pharmaceutical industry an advantage
* Working knowledge of current registration requirements for dossier
preparation and procedure running an advantage
* Solid knowledge of specific national requirements in usual target
registration countries an advantage
* IT tools utilised in RA department e.g. for Regulatory
intelligence, eCTD, change control etc.
Position: Regulatory Affairs Officer ? **Apply on the website**
Month Contract
JOB DESCRIPTION
On behalf of our client, a global pharmaceutical company, we are
currently recruiting for a Regulatory Officer Submissions This is a
**Apply on the website** month contract, full-time role.
OBJECTIVES
* Ensure timely preparation and compilation of registration dossier
components in accordance to EU or relevant Health Authority standards,
and corporate requirements
* Under supervision of the senior RA person (if required), manage
international regulatory submissions according to company strategy and
ensure registration deadlines are met
* Responding to Health Authorities&#**Apply on the website**;
queries and deficiencies in a timely manner
* Liaise with other departments to support the timely introduction
of new product into markets
* Maintain assigned products&#**Apply on the website**; Marketing
Authorisations via submission of the appropriate variations and
renewals in a timely manner
* Communication of Health Authority approvals/final decisions to the
relevant departments
* Build departmental awareness of local regulatory requirements in
relevant markets
* Compile regulatory components of annual product quality review
(PQR) and PSUR/PBER
DUTIES
DOSSIER MANAGEMENT
* TASKS RELATED TO THE RA PLAN
* Under supervision of the senior RA person (if required), submit
Marketing Authorisation Applications (MAAs) to Health Authorities
according to the registration plan and company&#**Apply on the
website**;s registration strategy.
* Proactively inform RA Manager and other involved functions
regarding all identified risks related to the planned MAA.
* Support the process of Scientific Advice from Health Authorities
by liaising with the relevant Authority and preparing the necessary
documents. COMPILATION OF REGISTRATION DOSSIERS FOR IDENTIFIED
COUNTRIES Review of registration dossier components for accuracy,
completeness and compliance with EU or relevant Health Authority
regulations and relevant guidelines; ensure that all specific national
requirements are met.Identify deficiencies and risks associated with
dossier quality and consult it with senior RA person and/or RA
Manager.Raise all identified risks related to the quality of the
dossier in order to meet submission deadlines, without a compromise in
the quality of the submission. SUBMISSION AND REGISTRATION PROCESS
Prepare, as per internal SOP, the data needed to make all required
registration fees in a timely manner.Dispatch the documentation in the
appropriate manner in order to deliver it to the relevant Health
Authority or local Regulatory Service Provider or local Marketing
Authorisation Holder (MAH.Answer all queries received from Health
Authorities during the validation phase of registration.Ensure all
internal RA databases are updated with any new specific national
requirements.Address all deficiencies identified by the Health
Authority in an appropriate manner within the required timelines.
During the Response to Questions preparation liaise closely with
internal/external contacts, relevant departmental staff and Health
Authorities to ensure efficient and timeous product
registration.Consult with senior RA person during RtQ document
preparation.Communicate any change in status for assigned tasks. Raise
all identified risks related to the deficiencies from Health
Authorities which might cause negative decision of procedure or delays
in timelines. MAINTAIN THE ASSIGNED PRODUCTS? MARKETING
AUTHORISATIONS IN TERRITORY Under senior RA person supervision (if
required), review MAs in accordance with registration requirements and
track change controls according to internal processes.Review, prepare
and compile the registration documentation required to maintain MAs,
for example variations (required internally or requested by Regulatory
Authorities), any supplements to dossiers, notification, renewals.
REGULATORY GOOD PRACTICE Perform assigned work according to current
good regulatory practice and in compliance with current legislation
and regulatory guidelines at all times.Ensure that any regulatory
changes communicated to the pharmaceutical industry by Regulatory
Authorities are raised to the RA Manager in order to implement them
without delay within the relevant department.
REQUIREMENTS
* Life sciences (BSc in Chemistry/ Biology, etc.) or pharmacy degree
* Experience in a regulatory affairs environment required
* Experience in the pharmaceutical industry an advantage
* Working knowledge of current registration requirements for dossier
preparation and procedure running an advantage
* Solid knowledge of specific national requirements in usual target
registration countries an advantage
* IT tools utilised in RA department e.g. for Regulatory
intelligence, eCTD, change control etc.
We need : English (Good)
Type: Permanent
Payment:
Category: Others
