Employal ®

Regulatory Affairs Manager

Posted on May 18th, 2009 by Employal Inc.

Job Number: 051109548

Terms of Employment: Full Time

Salary: To Be Determined Per year

Anticipated Start Date: As soon as possible

Province: Ontario

Location: Toronto GTA

Number Of Vacancies: 1

Skill Requirements: -Bachelor of Science Degree in Pharmacology, Toxicology, Biological Sciences, or equivalent. Master's Degree, preferred -A minimum of 5 years of experience in Regulatory with an emphasis in OTC Regulatory -Must have excellent working knowledge of the Canadian Food & Drug Act and Regulations and applicable Provincial Regulations -Experience with compiling, writing, submitting and managing approvals of DIN, NPN, NDSAC submissions, CTA, NDS and preferably OTC S/NDS that include C&M, clinical safety and efficacy data. -Experience with submitting and managing approvals of ASC and PAAB submissions Candidates with demonstrated success in the OTC Regulatory Environment, and knowledge of drug development (chemistry and manufacturing, clinical studies, etc.) in the pharmaceutical industry, will be given strong preference. Candidates with OTC or comparable background and strong writing skills will be given .

Employer: Employal Inc.

How to Apply: Please use our Online Application below to send your profile. Thank you for your time.

Note: Candidates with OTC or comparable background and strong writing skills will be given strong consideration. Please Indicate Your Remuneration Expectations.

BRIEF DESCRIPTION OF POSITION

The Regulatory Affairs Department of the Consumer Care Division is primarily concerned with maximizing and protecting the commercial interests of the company. It is concerned with the registration of new products and continued support of existing products according to Federal and Provincial Regulations.

Primary Responsibilities:

- Formulating, managing and executing submission strategies in order to achieve the objectives of specific Brands/Pillars within CC. This includes management of Regulatory staff as well as medical and regulatory Consultants

- Developing and maintaining a close working relationship with Marketing, Sales, Quality Assurance, Project Management, Legal and New Business Groups, so that drug development, filing of submissions and maintenance of product compliance, are undertaken in a timely manner, consistent with applicable Federal and Provincial Regulations.

- Establishes and maintains contacts with Company Regulatory and Medical staff in US and Global, in an effort to synergize regulatory activities and facilitate the retrieval of information towards completing the objectives.

- Of paramount importance is the development and maintenance of excellent working relationships with Health Canada and Industry Associations, aiding in the potential reduction of filing requirements and timeliness for approvals

- Liaise with Marketing regarding the advertising and promotion of Consumer Care products as well as negotiating Advertising Standards Canada (ASC) and Pharmaceutical Advertising Advisory Board (PAAB) approval

- Proactively monitor product scheduling changes for Consumer Care and competitor products

- Identify and communicate changes in the OTC Regulatory Environment and their potential impact relative to Consumer Care