Contact Us

505-207-7740

International location, requires work authorization
M. Pharmacy, B. Pharmacy
Solid dose, tablets, capsules, powders, injectables
13 years in international drug Regulatory Affairs and 3 years in Quality Assurance. // Familiar with scientific regulatory guidelines of EMA/ICH/FDA/Europe/ Health Canada and other global countries.

EDUCATION:

M. Pharmacy in Pharmaceutics

B. Pharmacy

OTHER SKILLS

Export order review/approval in SAP system
Involve in payment transfer activity for various regulatory agencies/customers.
Preparing the registration requirements check list for dossier.
Computer skills: MS Word, Excel, PowerPoint and other applications which are relevant to job profile.
Languages: English, Hindi, Telugu, kanada
Good planning and time management skills and ability to manage multiple projects under strict timelines.
Excellent verbal and written communication skills.
Guiding to the team regarding technical/commercial related aspects.
Submitting MAI application to Pharmexcil for reimbursing of registration expenses

Experience

Employer # 5:

Date of employment : January 2018 to current

Department : Regulatory Affairs

Designation : Senior Manager

Co-ordinate with our development team in generation of development documents for the registration application and provide the scientific input for the compilation of registration application for Europe and Canada and global regulatory requirements.
To provide inputs / suggestion for new development projects on regular basis.
Review of development documents (JOS, development report, CDR, Executed documents and other technical documents) for regulatory submission.
Ensure to meets all documents in-line with current regulatory requirements.
Assess drug master file documentation supplied by the manufacturer of API against the current regulatory requirement and prepare gap analysis for API manufacturer and submit the suitable documents to health authority.
Execution of action items with supporting of cross functional team
Co-ordination with IBD and project management team for project progress and planning the dossier filing.
Review and submission of eCTD dossiers for Europe and Canada Markets.
Follow up with various customers for on-time submission of regulatory applications and responses
To prepare gap analysis to queries raised customer and health authorities (Europe/Canada/Australia) for cross functional team.
Response to customer and health authority queries received from Europe and Canada on time.
Review of change controls for regulatory assessment and update the same in post approval change application based on the nature of change.
Planning to conduct the team learning session to update current regulatory guidance.
Team review activities shall be conducted regularly to know the gaps and intervene for addressing the gaps on-time.
Maintain the yearly targets as per the management and track the deliverables in monthly wise.
To prepare monthly report for management on all regulatory activities and ensure to meet the timelines for deliverables.
Responsible for strategize regulatory submissions to various countries and life cycle management of all approved products.
To maintain an internal regulatory database, with all requisite details, and necessary supporting documentation as to facilitate the operation of the regulatory affairs and maintain a regulatory filing system.
To perform the other duties of responsibility project management and periodic review of progress of new projects in the interest of the company.

Date of employment : July 2004 – February 2006

Department : Quality Assurance

Designation : QA officer

Employer # 4:

Date of employment : September 2012- January 2018

Department : Regulatory Affairs

Designation : Deputy Manager – Senior Manager

Review and submission of dossiers to various global regulatory authorities (Emerging market).
Execution of action items with supporting of cross functional team
Dossier planning shall be done based on the IBD requests and priority shall be given based on the customer / market requirement.
Response to queries raised by customer and regulatory authorities on-time.
Review of artworks and developed the harmonized artworks system to avoid multiple indents.
Attending the product launch and other post approval change
Handled team size of max. 20 for regulatory filings and post approval change.
Conducting team review meeting regularly to improve the project deliverables.
Responsible for strategize regulatory submissions to various countries and life cycle management of all approved products.
To maintain an internal regulatory database, with all requisite details, and necessary supporting documentation as to facilitate the operation of the regulatory affairs and maintain a regulatory filing system.
Involve in the registration payments for various regulatory authorities directly or through local customer.

Employer # 3:

Date of employment : November 2010- September 2012

Department : Regulatory Affairs

Designation : Asst. Manager

Review and submission of dossiers to various global regulatory authorities (Emerging market).
Execution of action items with supporting of cross functional team
Dossier planning shall be done based on the IBD requests and priority shall be given based on the customer / market requirement.
Response to queries raised by customer and regulatory authorities’ on-time.
Review of artworks and developed the harmonized artworks system to avoid multiple indents.
To maintain an internal regulatory database, with all requisite details, and necessary supporting documentation as to facilitate the operation of the regulatory affairs and maintain a regulatory filing system
Regular review with team for progress of deliverables and review of final technical documents before sharing to customer and Authority.

Employer # 2:

Date of employment : October 2007- October 2010

Department : Regulatory Affairs

Designation : Research Associate IV

Compilation and review of registration dossier to various regulatory authorities (Emerging) and compiled dossier to Eastern Europe countries.
Response to customer and regulatory authority queries.
Execution of action items with supporting of cross functional team
Follow up with various customers for on-time submission of regulatory applications and responses on time.

Roles and responsibilities at M/s Okasa and M/s Medreich Limited (QA):

Preparation and review of Batch manufacturing records.
Line clearance for manufacturing and packaging activates.
Review of process validation report and annual product quality review reports.
Release of batches after completion of batch manufacturing, packaging and quality control report review.
Review of QMS documents change controls, deviation
Involving in the international regulatory authorities audit from various countries/customer audit

Employer # 1:

Date of employment : February 2006 – October 2007

Department : Quality Assurance

Designation : QA officer

ACHIEVEMENTS

Contributed as good customer service.
Implemented artwork harmonization to avoid multiple indents, save cost
Achieved good number of fillings and product registrations during my turnover
Achieved the filings and approvals as per the Management expectations (Europe and Canada)
Motivating the team for better output
First launch for Algeria and other emerging markets
Crossed 300 regulatory filings with minimal resources in 5 years.
Achieved 160+ regulatory approvals for various emerging market countries in 5 years with limited resources.
Initiated new countries regulatory submission.
Involved in regulatory GMP audits and ensure to get the cGMP inspection report in-time.

RESUME REQUEST: 505-207-7740 // jobs@pharmaboard.com