Wizaltia Solutions
Location
Chennai | India
Job description
Role : Regulatory Affairs Manager
Location: Delhi / Mumbai
Education and Experience:
Bachelors degree in a relevant scientific discipline; advanced degree preferred.
Minimum of 4 years of experience in regulatory affairs within the pharmaceutical or
medical device industry.
Previous experience in managing regulatory submissions compliance activities and cross
functional projects.
CTC: 8lpa to 10lpa max
Position Overview:
We are seeking a highly skilled and experienced Regulatory Affairs Manager to join our dynamic
team in Chosen. The Regulatory Affairs Manager will be responsible for overseeing all aspects of
regulatory compliance and strategy to ensure adherence to
This role requires a strong understanding of pharmaceutical regulatory processes excellent
communication skills and the ability to work collaborative
Key Responsibilities:
1. Regulatory Compliance Oversight:
Analyze and interpret complex regulations and assess their impact on product development and
marketing strategies.
a) Assist in preparation of documentation needed for regulatory submissions.
b) Assist Product Development department in maintain
Ensure compliance with regional regulations and standards in local markets.
a) Assist quality management system audits including regulatory parts of MDSAP.
b) Ensure compliance of labeling materials with the Generics Law and other relevant laws.
c) Ensure regulatory support to GMP inspections if required
d) Ensure to file new product registration and update the current registration file in timely
manner.
Maintain knowledge of changes in regulatory legislation and guidelines and implement necessary
adjustments to ensure compliance.
a) Monitor and timely reflect the risks of MOH local legislation and regulatory normative
changes.
b) Participate in MDSAP audit as a regula
c) Prepare all the SOP associated with the MDSAP and ISO13485 registration process and
audit.
d) Prepare submit and manage submissions for TPD product licenses.
Regulatory Affairs Manager
Bachelors degree in a relevant scientific discipline; advanced degree preferred.
of experience in regulatory affairs within the pharmaceutical or
medical device industry.
Previous experience in managing regulatory submissions compliance activities and cross
We are seeking a highly skilled and experienced Regulatory Affairs Manager to join our dynamic
The Regulatory Affairs Manager will be responsible for overseeing all aspects of
regulatory compliance and strategy to ensure adherence to global & local regulations and standards.
This role requires a strong understanding of pharmaceutical regulatory processes excellent
communication skills and the ability to work collaboratively with crossfunctional teams.
e Oversight:
Analyze and interpret complex regulations and assess their impact on product development and
Assist in preparation of documentation needed for regulatory submissions.
Assist Product Development department in maintaining product safety compliance.
Ensure compliance with regional regulations and standards in local markets.
Assist quality management system audits including regulatory parts of MDSAP.
Ensure compliance of labeling materials with the Generics Law and other relevant laws.
Ensure regulatory support to GMP inspections if required
Ensure to file new product registration and update the current registration file in timely
n knowledge of changes in regulatory legislation and guidelines and implement necessary
adjustments to ensure compliance.
Monitor and timely reflect the risks of MOH local legislation and regulatory normative
Participate in MDSAP audit as a regulatory SME as required
the SOP associated with the MDSAP and ISO13485 registration process and
Prepare submit and manage submissions for TPD product licenses.
Bachelors degree in a relevant scientific discipline; advanced degree preferred.
of experience in regulatory affairs within the pharmaceutical or
Previous experience in managing regulatory submissions compliance activities and cross
We are seeking a highly skilled and experienced Regulatory Affairs Manager to join our dynamic
The Regulatory Affairs Manager will be responsible for overseeing all aspects of
regulations and standards.
This role requires a strong understanding of pharmaceutical regulatory processes excellent
functional teams.
Analyze and interpret complex regulations and assess their impact on product development and
Assist in preparation of documentation needed for regulatory submissions.
Assist Product Development department in maintaining product safety compliance.
Assist quality management system audits including regulatory parts of MDSAP.
Ensure compliance of labeling materials with the Generics Law and other relevant laws.
Ensure to file new product registration and update the current registration file in timely
n knowledge of changes in regulatory legislation and guidelines and implement necessary
Monitor and timely reflect the risks of MOH local legislation and regulatory normative
the SOP associated with the MDSAP and ISO13485 registration process and
2. Regulatory Strategy Development:
Develop and implement
medical devices.
Provide expert regulatory input to strategic decision
Shape regulations and standards to create a favorable regulatory environment for the business.
3. Submission Management:
Compile prepare review and submit regulatory submissions to authorities.
Manage global & local pre
Ensure timely submissions of post
processes.
4. Quality Assurance and Compliance:
Assess the acceptability of quality preclinical and clinical documentation for submission
filing.
Coordinate compliance with internal quality management systems and external regulatory
requirements.
Ensure regulatory compliance in
compliance with federal and state laws and regulations.
5. CrossFunctional Collaboration:
Liaise with crossfunctional teams to provide regulatory support for product development
manufacturing changes
Represent the regulatory affairs function on cross
regulatory input to support project objectives.
Collaborate with internal stakeholders to ensure alignment with business strategies and
objectives.
6. Regulatory Relationship Management:
Build and maintain effective relationships with regulatory authorities industry associations
and other external stakeholders.
Interface directly with health authorities and participate in regulatory meeting
inspections as necessary.
JD Regulatory Affairs
2. Regulatory Strategy Development:
Develop and implement global & local regulatory strategies for new and modified drugs and
Provide expert regulatory input to strategic decisionmaking processes.
Shape regulations and standards to create a favorable regulatory environment for the business.
le prepare review and submit regulatory submissions to authorities.
premarket and postmarket submission activities.
Ensure timely submissions of postapproval commitments and coordinate regulatory approval
e and Compliance:
Assess the acceptability of quality preclinical and clinical documentation for submission
Coordinate compliance with internal quality management systems and external regulatory
Ensure regulatory compliance in commercial activities and support efforts to ensure
compliance with federal and state laws and regulations.
Functional Collaboration:
functional teams to provide regulatory support for product development
and validation activities.
Represent the regulatory affairs function on crossfunctional project teams and provide
regulatory input to support project objectives.
Collaborate with internal stakeholders to ensure alignment with business strategies and
6. Regulatory Relationship Management:
Build and maintain effective relationships with regulatory authorities industry associations
and other external stakeholders.
Interface directly with health authorities and participate in regulatory meeting
inspections as necessary.
Affairs Manager
Page 2 of 3
rategies for new and modified drugs and
Shape regulations and standards to create a favorable regulatory environment for the business.
le prepare review and submit regulatory submissions to authorities.
market submission activities.
approval commitments and coordinate regulatory approval
Assess the acceptability of quality preclinical and clinical documentation for submission
Coordinate compliance with internal quality management systems and external regulatory
commercial activities and support efforts to ensure
functional teams to provide regulatory support for product development
functional project teams and provide
Collaborate with internal stakeholders to ensure alignment with business strategies and
Build and maintain effective relationships with regulatory authorities industry associations
Interface directly with health authorities and participate in regulatory meetings and
Stay current on all regulatory market and industry developments to inform regulatory
strategies and decisions.
Required Skills and Qualifications:
Hard Skills:
Indepth knowledge of Regulatory Affairs practices and princ
Familiarity with the Pharmaceutical Industry and relevant regulations (e.g. FDA
EMA).
Proficiency in MS Office Suite including Excel Word and PowerPoint.
Strong understanding of biology chemistry pharmacology and medical device
technologies.
Ability to manage operations efficiently including project management skills.
Experience in compiling and submitting regulatory documentation.
Familiarity with technical areas related to pharmaceutical and medical device
development.
Comfort with continu
Soft Skills:
Exceptional written and oral communication skills.
Excellent interpersonal skills and the ability to collaborate effectively with diverse
teams.
Strong organizational capacity and
Analytical ability and problem
Strategic thinking and leadership capabilities.
Negotiation and influencing skills.
Selfmotivated with the ability to work independently and proactively.
Accountability integrity and
Ability to multitask and prioritize responsibilities in a fast
Presentation skills and the ability to convey complex information clearly and
effectively.
Join our team and play a pivotal role in ensuring
pharmaceutical products in the global & local
healthcare solutions and make a difference in peoples
JD Regulatory Affairs
Stay current on all regulatory market and industry developments to inform regulatory
Required Skills and Qualifications:
depth knowledge of Regulatory Affairs practices and principles.
Familiarity with the Pharmaceutical Industry and relevant regulations (e.g. FDA
Proficiency in MS Office Suite including Excel Word and PowerPoint.
Strong understanding of biology chemistry pharmacology and medical device
Ability to manage operations efficiently including project management skills.
Experience in compiling and submitting regulatory documentation.
Familiarity with technical areas related to pharmaceutical and medical device
Comfort with continuous sitting for prolonged periods due to extensive desk work.
Exceptional written and oral communication skills.
Excellent interpersonal skills and the ability to collaborate effectively with diverse
Strong organizational capacity and attention to detail.
Analytical ability and problemsolving attitude.
Strategic thinking and leadership capabilities.
Negotiation and influencing skills.
motivated with the ability to work independently and proactively.
Accountability integrity and a proactive approach to tasks.
Ability to multitask and prioritize responsibilities in a fastpaced environment.
Presentation skills and the ability to convey complex information clearly and
Join our team and play a pivotal role in ensuring regulatory compliance and driving the success of our
global & local market. Apply now to contribute to innovative
nd make a difference in peoples lives.
Affairs Manager
Page 3 of 3
Stay current on all regulatory market and industry developments to inform regulatory
iples.
Familiarity with the Pharmaceutical Industry and relevant regulations (e.g. FDA
Proficiency in MS Office Suite including Excel Word and PowerPoint.
Strong understanding of biology chemistry pharmacology and medical device
Ability to manage operations efficiently including project management skills.
Experience in compiling and submitting regulatory documentation.
Familiarity with technical areas related to pharmaceutical and medical device
ous sitting for prolonged periods due to extensive desk work.
Excellent interpersonal skills and the ability to collaborate effectively with diverse
motivated with the ability to work independently and proactively.
paced environment.
Presentation skills and the ability to convey complex information clearly and
regulatory compliance and driving the success of our
market. Apply now to contribute to innovative
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