A C Guards

Hyderabad

L B Nagar


Trainee Executive
Apply
locations
India
time type
Full Global Regulatory Affairs (PEH GRA) Job Description (JD)

Job Title: Annual Report Strategist (CMC)/ Trainee Executive

Organization : PEH GRA

Line (if applicable): India Strategy

Department/Group (if applicable) : Legacy Brands CMC - NDA Annual Report

Region and/or Country (if applicable) : Not Applicable



Organizational Relationship(s) including to whom the position reports (JD Job Title):

Position reports to Manager, Legacy Brands NDA AR CMC.

Position Purpose

Functions as an Annual Report Strategist for Brands-NDA Annual Report (AR) team, working with CMC Global Regulatory Strategist - CMC (GRS-CMC) and Cross Functional Teams to prepare and submits the CMC contributions of US NDA/ANDA/BLA/PMA/IND Annual Reports as per defined timelines.

Primary Responsibilities 

Manages day-to-day regulatory activities associated with assigned Annual Reports within agreed upon timelines.
Reviews changes made during the reporting period for completeness and accuracy. Develops initial Annual Report regulatory strategy while considering registered content and seeks endorsement by the CMC GRL.
Authors and/or compiles CMC contributions based on changes made during the appropriate reporting period, i.e. Module 1 & 3 under the guidance from the CMC GRL as appropriate and within agreed timelines.
Reviews all appropriate systems for post approval changes submitted and approved along with commitments made and fulfilled 
Reviews technical/supportive information for submission to support AR changes
Manages and reviews stability contributions for accuracy and consistency with commitments
Reviews and applies pertinent US regulatory guidelines to confirm Annual Reportable filing classifications.
Develops technical justification of change for agency submission as needed
Updates impacted dossier components as needed
Coordinates M3.2.R Ancillary documents as needed
Escalates delays in timelines and flags identified risks to the CMC GRL and/or appropriate leadership
Coordinates internal document review and sign off.
Utilizes Pfizer’s CMC systems, i.e. GDMS, PDM, SPA, etc., as appropriate.
Ensures compliance to Pfizer internal procedures and training SOPs            (Power 2 Learn).
Technical Skill Requirements

Knowledge on Regulatory requirements of post approval changes  for US Oral Solid Dosage form and sterile injectable manufacturing and regulatory data requirements for submission of ARs.
Knowledge in retrieving information from company’s and regulatory agency databases.
Basic level of knowledge on general standards, processes and policies of Pfizer/Pharmaceutical manufacturing Industry.
Qualifications (i.e., preferred education, attributes)

Preferred Education:
      Minimum – Postgraduate in Pharmacy / Science

Salarpuria-Sattva Knowledge City, Inorbit Mall Rd, Durgam Cheruvu Rd, Silpa Gram Craft Village, HITEC City, Hyderabad, Telangana 500081, India
Madhapur, Hyderabad

Work location

Project & Program Management

Department

Other Program / Project Management

Role / Category

Full Time

Employment type

Day Shift

Shift

Min. 1 year

Experience

Graduate

Education

Good (Intermediate / Advanced) English

English level

26 - 30 years

Age limit

Female

Gender

Matechno Solutions

Name

Bahadurguda, Hyderabad, Telangana, India
LB Nagar, Hyderabad

Address

Trainee Executive

Matechno Solutions is aggressively hiring for the job profile of Trainee Executive at Hyderabad in Madhapur locality. Kindly go through the FAQs below to get all answers related to the given job.

 1. How much salary can I expect as a Trainee Executive in Matechno Solutions in Hyderabad?
 
 Ans. You can expect a minimum salary of 23,000 INR and can go up to 25,000 INR. The salary offered will depend on your skills, experience and performance in the interview.
 
 2. What is the eligibility criteria to apply for Trainee Executive in Matechno Solutions in Hyderabad?
 
 Ans. The candidate should have completed Graduate degree and people who have 1 to 31 years are eligible to apply for this job. You can apply for more <a href=/jobs/jobs-in-hyderabad>jobs in Hyderabad</a> to get hired quickly.
 
 3. Is there any specific skill required for this job?
 
 Ans. The candidate should have Good (Intermediate / Advanced) English skills and sound communication skills for this job. 
 
 4. Who can apply for this job? 
 
 Ans. Only Female candidates can apply for this job.
 
 5. Is it a work from home job? 
 
 Ans. No, it’s not a work from home job and can’t be done online. You can explore and apply for other <a href="/jobs/work_from_home-jobs-in-hyderabad"}>work from home jobs in Hyderabad</a> at apna.
 
 6. Are there any charges or deposits required while applying for the role or while joining? 
 
 Ans. No work-related deposit needs to be made during your employment with the company.
 
 7. How can I apply for this job?
 
 Ans. Go to the <a href=https://l.apna.co/Ryy8zU2ocTb>apna app</a> and apply for this job. Click on the apply button and call HR directly to schedule your interview.
 
 8. What is the last date to apply? 
 
 Ans. The last date to apply for this job is 25-Mar-2023.
 
		For more details, download apna app and find <a href="/jobs/full_time-jobs-in-hyderabad">Full Time jobs in Hyderabad</a>. Through apna, you can find jobs in 74 cities across India. Join NOW!

India

Trainee Executive
Apply
locations
India
time type
Full Global Regulatory Affairs (PEH GRA) Job Description (JD)

Job Title: Annual Report Strategist (CMC)/ Trainee Executive

Organization : PEH GRA

Line (if applicable): India Strategy

Department/Group (if applicable) : Legacy Brands CMC - NDA Annual Report

Region and/or Country (if applicable) : Not Applicable



Organizational Relationship(s) including to whom the position reports (JD Job Title):

Position reports to Manager, Legacy Brands NDA AR CMC.

Position Purpose

Functions as an Annual Report Strategist for Brands-NDA Annual Report (AR) team, working with CMC Global Regulatory Strategist - CMC (GRS-CMC) and Cross Functional Teams to prepare and submits the CMC contributions of US NDA/ANDA/BLA/PMA/IND Annual Reports as per defined timelines.

Primary Responsibilities 

Manages day-to-day regulatory activities associated with assigned Annual Reports within agreed upon timelines.
Reviews changes made during the reporting period for completeness and accuracy. Develops initial Annual Report regulatory strategy while considering registered content and seeks endorsement by the CMC GRL.
Authors and/or compiles CMC contributions based on changes made during the appropriate reporting period, i.e. Module 1 & 3 under the guidance from the CMC GRL as appropriate and within agreed timelines.
Reviews all appropriate systems for post approval changes submitted and approved along with commitments made and fulfilled 
Reviews technical/supportive information for submission to support AR changes
Manages and reviews stability contributions for accuracy and consistency with commitments
Reviews and applies pertinent US regulatory guidelines to confirm Annual Reportable filing classifications.
Develops technical justification of change for agency submission as needed
Updates impacted dossier components as needed
Coordinates M3.2.R Ancillary documents as needed
Escalates delays in timelines and flags identified risks to the CMC GRL and/or appropriate leadership
Coordinates internal document review and sign off.
Utilizes Pfizer’s CMC systems, i.e. GDMS, PDM, SPA, etc., as appropriate.
Ensures compliance to Pfizer internal procedures and training SOPs (Power 2 Learn).
Technical Skill Requirements

Knowledge on Regulatory requirements of post approval changes for US Oral Solid Dosage form and sterile injectable manufacturing and regulatory data requirements for submission of ARs.
Knowledge in retrieving information from company’s and regulatory agency databases.
Basic level of knowledge on general standards, processes and policies of Pfizer/Pharmaceutical manufacturing Industry.
Qualifications (i.e., preferred education, attributes)

Preferred Education:
 Minimum – Postgraduate in Pharmacy / Science


More about this Trainee Executive job


Matechno Solutions is aggressively hiring for the job profile of Trainee Executive at Hyderabad in Madhapur locality. Kindly go through the FAQs below to get all answers related to the given job.

 1. How much salary can I expect as a Trainee Executive in Matechno Solutions in Hyderabad?
 
 Ans. You can expect a minimum salary of 23,000 INR and can go up to 25,000 INR. The salary offered will depend on your skills, experience and performance in the interview.
 
 2. What is the eligibility criteria to apply for Trainee Executive in Matechno Solutions in Hyderabad?
 
 Ans. The candidate should have completed Graduate degree and people who have 1 to 31 years are eligible to apply for this job. You can apply for more <a href=/jobs/jobs-in-hyderabad>jobs in Hyderabad</a> to get hired quickly.
 
 3. Is there any specific skill required for this job?
 
 Ans. The candidate should have Good (Intermediate / Advanced) English skills and sound communication skills for this job. 
 
 4. Who can apply for this job? 
 
 Ans. Only Female candidates can apply for this job.
 
 5. Is it a work from home job? 
 
 Ans. No, it’s not a work from home job and can’t be done online. You can explore and apply for other <a href="/jobs/work_from_home-jobs-in-hyderabad"}>work from home jobs in Hyderabad</a> at apna.
 
 6. Are there any charges or deposits required while applying for the role or while joining? 
 
 Ans. No work-related deposit needs to be made during your employment with the company.
 
 7. How can I apply for this job?
 
 Ans. Go to the <a href=https://l.apna.co/Ryy8zU2ocTb>apna app</a> and apply for this job. Click on the apply button and call HR directly to schedule your interview.
 
 8. What is the last date to apply? 
 
 Ans. The last date to apply for this job is 25-Mar-2023.
 
For more details, download apna app and find <a href="/jobs/full_time-jobs-in-hyderabad">Full Time jobs in Hyderabad</a>. Through apna, you can find jobs in 74 cities across India. Join NOW!

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