Regulatory Affairs Pharmacist Needed at CrystalBlend Group

Employment Nigeria 27-Jul-2016 LAGOS , Health Administrative Pharmaceutical

CrystalBlend Group - Our client, is recruiting suitably qualified candidates to fill the position below:

POSITION : Regulatory Affairs Pharmacist

Job Roles

To manage the regulatory department and develop processes so that new chemical entities, new dosage forms and new indications are registered in a timely fashion.
Overall responsibility for compiling regulatory submissions to NAFDAC and other regulatory bodies, drafting Product Information, Consumer Information, literature searches to support submissions, product analysis, changes in manufacturing, pack sizes, CPI and PI development, packaging changes, MIMS notification and other regulatory activities.
Ensure that all state and federal regulatory requirements are addressed for the clinical research programme and for marketed products.
Develop professional relationships with NAFDAC staff and proactively monitor relevant governmental bodies to identify changes in legislation/regulations.
Provide regulatory expertise to clinical project teams (CTN applications, importation of clinical trial material, reporting of adverse events).
Provide regulatory expertise to global product development teams.
Conduct training sessions for CRAs and sales representatives on ADR reporting and the importance of pharmacovigilance.
Working with marketing to ensure that the content of all promotional material is fully supported by the Product Information and literature, and in accordance with the guidance offered by NAFDAC and other government regulators.

Minimum Qualification

Bachelor's Degree in Pharmacy
The Person MUST have minimum 4 years considerable experience in Superintending and Regulatory affairs in relevant Pharmaceutical industry.

Desired Skills:

Regulatory Filings
Reporting
Accuracy
Administrative
Microsoft
Project Management
Regulatory Filings
Reporting
Good knowledge on research, product development and regulatory fields
Analytical and strategizing abilities
Capable to manage the entire regulatory department of the organization
Hiring, training, and monitoring the performance of other personnel
Proficient use of Office applications, email, social media and other communication tools essential.
Strategic experience for products and experience of Health Authorities meetings
Strong attention to details and organizational skills required

Remuneration
N2.8 M - N3.5 M depending on experience

How to Apply
Interested and qualified candidates should forward their updated resumes to: info@crystalblendng.com and crystalblendng@gmail.com

Sorry the application deadline for this job has elapsed

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Regulatory Affairs Pharmacist Needed at CrystalBlend Group

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