Regulatory Affairs

SAIFULLA KHAN

**** ***** ******, # **, ********** 15232 ● 608-***-**** ● ****.****@*****.***

Regulatory and Medical safety consultant

Dynamic clinical and drug safety professional with over 2 years of vast regulatory and clinical

safety experience, gained by working onsite for AstraZeneca India Pvt Ltd, Bangalore, India.

Experience includes filling of generic marketing authorization application to various regulatory

markets as well as planning the submission of periodic safety update reports to the respective

markets by following company’s Standard Operating Procedures, internal business practices and

regulatory guidance documents to ensure compliance with worldwide safety regulations and

corporate policies.

Key skills

Ø Preparation of MAA submissions in Europe and ROW markets

Ø FDA safety reporting regulations and guidelines

Ø Preparation of patients information leaflets,

Ø FDA and international regulations

Ø SAE/AE Reconciliation

Ø Regulatory Compliance

Education

Master of Science (Medicine Management)

University of Sunderland, Tyne and Wear, UK

Bachelor of Pharmacy

Rajiv Gandhi University of Health science, Bangalore, India

PROFESSIONAL EXPERIENCE

ASTRAZENECA PHARMA INDIA LTD BANGALORE, INDIA, 07/10 - 07/11

Astrazeneca is a global pharmaceutical and biologics company. It is the world's seventh-largest

pharmaceutical company measured by revenues and has operations in over 100 countries.

Regulatory Affairs & Medical safety Manager.

Ø Providing regulatory support to AZ UK regulatory team in one of the most crucial project

of Astra Zeneca.

Ø Expertise in submitting generic molecule dossiers in international markets like Central

Eastern European & CIS Countries.

Ø Planning and execution of periodic safety update reports as per the country specific

regulatory requirements.

Ø Performed medical coding using MedDRA and WHO-Drug dictionaries and composing

detailed case narratives.

Ø Reviewing source documents such as BE Report, Clinical & Nonclinical reports for its

regulatory adequacy across all the ROW Markets and preparing scoping report before

implementation in the dossiers.

Ø Preparing CPT (Core Pack text) PIL (Patient information leaflet), SmPc (Summary of

Product characteristics) and labeling mockups.

Ø Co-ordination with AZ UK Team to freeze administration documents for different

markets and publishing the dossier.

Ø GAP analysis of the dossiers during review, preparing the scoping report along with

comments.

Ø Follow-up with vendors (weekly Conference calls, Mails) to highlight the technical and

nontechnical issues upfront.

Ø Co-oridinating with the Project Management team and the marketing company in

different region to submit the dossiers for registration.

Ø Preparing draft templates (LOA, Declaration letter, Manufacturing Agreement,

Distribution agreement etc).

Ø Project plan execution and review, update reporting communication.

Ø Follow-up with the vendor for the upgrading the dossier (for both technical and

administrative documents).

Ø Providing the responses towards the queries for different regulatory authorities.

Ø Preparation, evaluation and gap analysis of the data, templates for filing the application.

PHARMALEAF INDIA PVT LTD 12/09 - 07/10

Regulatory executive

Ø Project plan execution and review update reporting communication with related stake

holders and regulatory authorities. Meeting the given task timely. Coordination with line

manager and escalation of the issues upfront.

Ø Handling international markets for regulatory submission. Preparation and submission of

BE Study, Clinical Trial, Import and Export application for Phase II and Phase III to the

Indian regulatory authority (DCGI).

Ø Prepared Dossier for BE study and Global Clinical Trial, filed for DCGI and obtained

CTA NOC and IL. Prepared a Regulatory strategy for filing of biological and controlled

drug to seek approval from various regulatory agencies.

SPECIALTIES

Communication: Internal communication within the team to achieve objective within timeline.

Interpersonal skills: Goal oriented work and accomplishing the task within given timelines by

assisting Team lead, colleagues and non technical staff.

Leadership style: Always a team person, and very active to contribute ideas, resources, apply

skills to successfully complete the task by working within the team.

Project Plan Execution and review update reporting communication with related stake holders

and regulatory authorities.

IT Skills: SAS Basic, MS office, Photo shop etc

PERSONAL PROFILE

Date of Birth : 08-15-1979

Nationality : Indian

Gender : Male

Martial Status : Married

Linguistic Proficiency : English, Hindi, Kannada, Urdu

Visa Status : J2

Employment authorization approved and eligible to work in US (reference can be given upon request)

References Available Upon Request

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