Job Openings

Source:Times Ascent, 30 July'08

Tremendous Oppurtunities For Engineers In Regulatory Affairs Sector

What Are Some Of The Essential Roles And Responsiblities Of Regulatory Affair Engineers ?

Responsibilities:
Regulatory Affairs inputs for Risk Management Files, Compliance Plan and design requirements for safety (safety standards).

Work to continually improve operating excellence with regards to process execution.

Provide support during internal and external audits of the GEHC Quality Management System within respected areas.

Roles:

For supporting the global regulatory submissions which include maintaining and implementing the company's regulatory affairs systems.

-Supporting all global regulatory submissions

-Authoring global regulatory submissions

-Conducting training to other employees on regulatory matters

-Assisting with the reclassification process

-Developing, implementing and maintaining regulatory standard operating procedures

JOB SUMMARY: The Quality Assurance and Regulatory Affairs Engineer is responsible for the complete QA/RA responsibilities throughout the enterprise (Marketing, Sales/Service, Supplier, R&D, Manufacturing and Customer.)

Clinical Trials And Drug Discovery Are The Major Areas Of Expansion And Interest

SOURCE:The Economic Times 25 July'08

DUAL PROGRAM IN BIOINFORMATICS - JOIN NOW

INDUSTRY PROGRAM IN PHARMA REGULATORY AFFAIRS-JOIN NOW

Dear Admin,
please can we know when the results of April2008 of Spring batch2007 will be published?

Regulatory Framework:SOPs For Ethical Regulation Of Drugs

EXTENTION OF SUBMISSION PERIOD

Dear co-ordinator,

I would like to know whether the submission period for assignment and research paper would be extended for autumn,07 batch of IPPRA.

Please reply,

with regards,

RAM KUMAR.S

Telemedicine

Diverse World Of Regulatory Affairs Professionals

This Article will focus on the Prominent Aspects of Regulatory Affairs(RA) Professionals and the opportunities open to RA professionals as they begin and Excel in their careers.We hope that it will help those readers with more experience when encouraging young professionals/graduates to explore what can be a lifelong and secure career.All functions with in the pharmaceutical,Biomedical,CRO's carry their own level of priority considering the Nature and Importance of work,but it is the regulatory affairs that Escalate.Diverse Field and Regulatory Related Roles of RA Professional as shown in the Figure are Crucial to the Industry.It is the RA Professional which Acts as a Backbone for the Industry.Professionals employed in this sector Interacts with the other Professionals Through out the Industry. Working at a Base Level in regulatory Sector will help professionals learn more and helps in improving Regulatory skills. As your Knowledge and Exprience grows you will become easily involved in strategic developement plans.Your Advice and Regulatory expertise become an integral part of regulatory Strategies.
However For Those of you who are considering RA as a career move,that Apart From various Pharmaceutical,biotechnolgy sector,the major mushrooming sector for RA Professional are the CRO's and consultancy area where many people begin their RA career. With the opportunity to work on a wide variety of projects with numerous companies, it is often commented that the experience you gain in these organisations in two months can be worth two years in a specialist department of a large pharmaceutical company.
So for those of you holding valueable medical and para medical degrees and still not getting a career start.This is the Time to Grab the oppurtunity for those who really want to make Regulatory Affair as a career.

BIOINFORMATICS PROJECT TRAINING FOR 2,4,6 MONTH AT BII

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Why To Join A Distance Learning Programe In Pharma Regulatory Affairs ?

WHAT ARE THE BENEFITS OF TAKING A DISTANCE LEARNNG PROGRAM IN PHARMA REGULATORY AFFAIRS?
The Program is with updated technology and one can study anytime anywhere from the Institute.You can quickly obtain a practical understanding of the regulatory processes in specific target markets, ensuring your products conform to regional standards. As regulations and directives are amended, you’ll be able to trace each step of the process. You’ll gain a unique insight into the pharmaceutical market. You’ll make more informed reports to strategic planning and change management groups, and write better and faster compliance submissions

CAREERS IN PHARMA REGULATORY AFFAIRS ?
Graduates from this Distance Learning program may pursue careers in the areas
of Regulatory Affairs and Quality Operations. Career options include the
pharmaceutical, biotechnological, veterinary, cosmetic and food industries.
Graduates will find employment as
· Regulatory Affairs Associates
· Regulatory Affairs Assistants
· Quality Assurance Associates
· Quality Assurance Investigators
· Documentation Administrators and
· Medical Information Associates
· In Contract Research Organization(CRO) Pharma regulatory affairs professionals are responsible for maintaining records of Common Technical Documents for Pharmaceutical Dossiers.

HOW DOES REGULATORY AFFAIRS CERTIFICATION ENHANCES SOMEONE’S EMPLOYMENT PROSPECTS ?
“Certified professionals "earn anywhere from 20 to 30% more than their peers. In addition, many companies--both large and small to midsize--are now beginning to indicate that REGULATORY AFFAIRS CERTIFICATION is a desirable qualification."

JOIN DISTANCE LEARNING PROGRAM IN PHARMA RUGULATORY AFFAIR AS A CAREER
A real advantage of a career in this area is that you get a holistic view of a drug’s
development. Act as intermediate with so many different people, from drug
development teams through to people in marketing and legal affairs, as well as
external health authorities, you serve as a Backbone – holding the whole operation
together.

For Latest News And Professional Information On Pharma Regulatory Affairs,Read Daily Updates and Pharma Regulatory Affairs Presentation On Blog

Regulatory Affairs Professional Development Framework

Regulatory affairs (RA) professionals play critical roles throughout the healthcare product lifecycle, from concept through product obsolescence. They provide strategic, tactical and operational direction and support for working within regulations to expedite the development and delivery of safe and effective healthcare products to individuals around the world. Continuous evolution in science and changes in the regulatory environment, health sector and general economics shape the dynamic and expanding scope of the regulatory affairs professional. Regulatory Affairs professionals must continually grow their knowledge and skills to be effective and to advance in their profession.The Regulatory Affairs Professionals Society (RAPS) was established in 1976 with a mission of creating the foundation for developing and nurturing the emerging healthcare product regulatory affairs profession. A key building block of establishing Regulatory Affairs as a profession was put into place in 1990 when RAPS introduced a professional certification, the Regulatory Affairs Certification (RAC). The development of the RAC was based upon extensive research on the scope of practice and specific activities of the professional with three to five years of regulatory experience, the target for this professional credential. This research has been replicated and updated several times, with studies extended to professionals involved with the European, US and Canadian regulatory systems.The role delineation research indicated the unique knowledge base of the profession, which extends through the healthcare product lifecycle and blends content from the sciences, law and business. These studies also indicated consistency in the general scope of responsibilities of the professionals at this level, distinct from geographic location.However, these studies focused on only one level of the profession. The RA profession today encompasses multiple levels, from the professional at entry level through the highly experienced professional with extensive technical knowledge and management responsibilities.
The PD Framework provides a general model for describing the Regulatory Affairs profession at the four career stages delineated in this project. For each level, the framework presents tasks and responsibilities organized according to the stages and steps in the healthcare product lifecycle as well as the associated knowledge and skills required by the professional.

Source : Regulatory Affairs Professional Society

For Latest News And Professional Information On Pharma Regulatory Affairs,Read Daily Updates and Pharma Regulatory Affairs Presentation On Blog

Rules Rule

Regulatory affairs is a young profession that's already making its mark in the world of drug development, where one false move can bring years of research to an unwelcome end. If your skills include communication and leadership, it may be for you.

Last year, global spending on prescription drugs exceeded US$600 billion. Topping the sales list were drugs to combat high cholesterol levels, heartburn, schizophrenia and asthma. But regardless of their sales strength, every drug had one thing in common: each had been scrutinized by regulatory-affairs professionals before reaching the pharmacy shelves. Employed by the drug companies and contract research organizations, these experts assemble huge dossiers of data and oversee the mountain of paperwork required by the regulatory agencies that oversee the industry."The basic responsibility is to interpret the regulations and guidelines of the different regulatory agencies,".Regulatory-affairs professionals are an essential part of the drug-development process, and jobs in the field typically crop up wherever there is healthy investment in R&D. These professionals have a vast scope. They prepare, submit and monitor submissions to regulatory agencies, and get involved in manufacturing, labelling, marketing and post-marketing activities. Increasingly, their involvement begins during the R&D phase, where they help smooth the transition from drug development to clinical trials.

Once a company identifies a promising compound, a regulatory-affairs team begins drawing up the plan that will guide the compound through development, clinical trials and onto the shelves. "We work with the scientific team during the preclinical phase to make sure that we have the right data," says Lisa Skeens, vice-president of regulatory affairs at Baxter in Deerfield, Illinois. "We are the liaison between the regulatory authorities and the company, the experts in understanding the regulations and the guidelines. We know through experience what the global regulatory agencies expect."

Preparing for the move

People come from all kinds of backgrounds, says Joseph Scheeren, head of global regulatory affairs at Bayer HealthCare's pharmaceuticals division in West Haven, Connecticut. Some join regulatory affairs immediately after finishing their education; others make internal moves from development or discovery, he says. New recruits can expect to receive a lot of mentoring and coaching during the first two years of their job. Regulatory professionals with experience in a specific therapeutic area are especially appealing to companies that are expanding into new areas.
Today's professionals see regulatory affairs as a career that offers continual learning and interaction with scientists and regulators. And with harmonization, changing regulations and the constant expansion of the therapeutic realm, it's never dull. "I've been in the regulatory-affairs area for almost 25 years, but I learn every day," says Scheeren.

Article Source:Nature