VP, Regulatory Affairs & Quality Assurance
Local candidates only
Responsible for the generation and implementation of regulatory strategies to ensure the successful development and approval of products. Directs regulatory activities to insure all relevant requirements and expectations are achieved in an optimal and compliant manner.
- Oversee assembly and creation of documentation to support investigational and marketing registration packages.
- Liaise with regulatory authorities as needed and as agreed with CEO for all aspects pertaining to drug development and approval.
- Provide high-level RA advice and identify regulatory requirements for clinical studies and marketing approval in the US market.
- Assess scientific data for registration purposes against regulatory requirements.
- Facilitate policy and development of standard interpretation of US regulations.
- Maintain awareness and relay information to Executive Management of regulatory legislation and assess its impact on business and BioSante product development programs.
- Seek innovative and creative solutions that comply with regulations, but are also sound from business and scientific perspectives.
- Provide contingencies and alternate approaches to Senior Management.
- Manage the Quality Assurance and Quality Control functions.
- Select, develop and evaluate personnel to ensure the efficient operation of the regulatory affairs function.
REQUIRED KNOWLEDGE AND EXPERIENCE:
- Master´s Degree in pharmacy, biology, chemistry, pharmacology or related subject
- Minimum of 15 years R&D experience or related area within a pharmaceutical and/or biotech industry.
- Minimum of 10 years experience in regulatory
- Successfully submitted and negotiated an initial NDA
- Knowledge of electronic CTD
- Knowledge of regulatory advertising and promotion requirements
- Publication strategy experience
|PREFERRED KNOWLEDGE AND EXPERIENCE:
- Demonstrated record of investigational and marketing application approvals
- Divisional RA leadership experience
- International experience
Human Resources and Job Opportunities
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The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed.