Manager- Regulatory Affairs required @ Bangalore "A"

Manager - Regulatory Affairs - Pharma @ Bangalore

• Experience 0 to 3 yrs

Job Description

M Pharma with 10 -15 years experience ( Europe, Australia, Japan market filing experience )Good

knowledge of regulatory pathways and options/strategy for Europe and othersKnowledge and experience

of preparing Common Technical Documents and Clinical Trial Application dossierShould prepare

position papers for internal presentation to Management and Task force committee - strategy for

registering the product in different markets, pros and cons, information on product related

competitors in similar markets, licensing requirements and end to end understanding of regulatory

procedures for registering a product in India, Europe and Rest of the worldBe able to manage the

changes during the life cycle of the productShould have understanding of GMP, GDP GLPsKnowledge of

preparing eCTD (electronic Commercial Technical Documents)Main focus will be on the development and

execution of regulatory strategy for the assigned components of regulatory applications and

submissionsManaging and coordinating various regulatory activities throughout the life cycle of the

project/productAdditional focus will be on appropriate planning for prioritization and coordination

of activities among functional areas and within Regulatory affairs, and for timely identification

and communication of project/product related concerns to the Head- RA such that same can be

addressed in a timely mannerThe position is expected to organise and lead s with regulatory

agencies and/or parent companyShould have excellent oral and written communication skills and

presentation skillsBe able to manage Team.Forwards

Degree: M.Pharm. (Pharmacy)

Additional Degree: B.Pharm. (Pharmacy)

Experience: 10-15

Company

Information: We are a company of 20 years standing specializing in quality manpower consulting

services. IDEAL establishes trust by working hand in glove with the esteemed clients. The goodwill

and confidence created with over a decade of professional services, our data bank is growing

rapidly with highly qualified candidates, matching the requirements of various organisations. Our s

and relationships help us in locating the right candidate. IDEAL also has vast experience in

advertising, conducting Mock Tests, Campus Interviews and Counseling Training. IDEAL provides

efficient smart service, maintaining high confidentiality and saving valuable time. Growing list of

satisfied clientele vouches for our impeccable track record.

Apply now

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