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Regulatory Affairs Manager/Associate Temp position with a permanent option

  • Anywhere

Company :
FERRING PHARMACEUTICALS INC.

Location :
Troy Hills, New Jersey

Expiry Date :
Sun, 07 Mar 2021 23:59:59 GMT

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Description :
Job Title:Regulatory Affairs Manager/Associate -Temp position with a permanent optionJob Description: Responsibilities – Responsible for regulatory submissions, approvals and compliance for worldwide market expansions and renewals – Full understanding of regulatory file template and ability to maintain and update the quality part (CMC sections) in regulatory file – Evaluate change requests and regulatory impact and establish the appropriate strategy for the projects at BTG – Ability to write variations/ supplements and to drive approvals globally – Maintain collaborative work with regulatory teams within BTG and globally – Provide regulatory support to development activities and drive clinical trial application under development projects – Review and approve Protocols, Reports and Validation documents – Responsible for continuously acquiring new knowledge and finding innovative solutions to regulatory challenges and issues – Provide regulatory CMC intelligence to cross-functional teams – Demonstration of full understanding of regulatory requirements for the biopharma industry (drugs, medical devices, biologicals) and demonstrate regulatory CMC expertise Qualifications – Academic degree in science (MSc or PhD) in any area of biology, life sciences or molecular biology – must – Hebrew and English at mother tongue level, with proven abilities in writing and editing of submission documents – must. – At least 5 years experience in the pharma industry, or 3 years in regulatory affairs and product registration of pharma products – must – Excellent oral and written communication skills, with ability to work as part of a team- must – Scientific understanding of CMC requirements and submission content concerning product quality- an advantage – Ability to simultaneously manage and drive multiple projects to achieve new registration and support change variations – must – Ability to work independently, work under pressure and to meet changing deadlines- must – Logical thinking, assertiveness, creativity and flexibility – must – Computer literacy, including experience with Microsoft Office Word, Excel and Power Point. – Understanding of GMP and Quality System requirements – an advantage – Computer literacy, including experience with Microsoft Office Word, Excel and Power Point. Knowledge of and experience with US and EU regulatory requirements for the biopharma industry (drugs, medical devices, biologicals) – an advantageLocation:BTG ( a Ferring company) We are proud to be an Affirmative Action/EEO Employer. EOE Minorities/Females/Protected Veterans/Disabled