Contract Opportunities

Senior Consultant, Local Regulatory Affairs – Spain and Portugal

Job No: 498756

Location: NJ Or CA, USA

Duration: 12 Months

Closing Date: 27/11/22

Reference: 1007

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This is an opening for a senior-level regulatory professional, joining an established team in one of G&L’s largest clients; a cutting edge biopharma with an enviable pipeline.

As demand for our services and solutions continues to increase, we have an exciting new opportunity for a Senior Manager/Business Partner – Human Resources to join our global team. Based in our Marlow/Paddington offices with flexibility, this is initially a 12 month fixed term career opportunity.

Responsibilities

Develop and implement the US and global regulatory strategies regarding clinical development for assigned projects.
Lead global and/or regional regulatory teams on assigned projects.
Develop and execute US regulatory strategy for clinical development and contingencies for assigned projects.
Serve as the primary interface for FDA on assigned projects.
Communicate project regulatory strategies and plans to management, cross-functional teams and any partners/collaborators to establish alignment.
Lead the preparation of submissions, which may include INDs, Briefing Documents, Orphan Drug Applications, Breakthrough Designation, Pediatric Study Plans, PPSRs, Fast Track Designation and Marketing Applications etc. Work with functional groups to define contributions to submissions. Lead regulatory submission teams for projects assigned.
Prepare company team for FDA and other health agency meetings, as required.
Serve as the primary interface with Regulatory CROs or local regulatory teams globally for coordination and preparation of submissions.
Represent Regulatory Affairs on various cross-functional teams, including Project Teams, Clinical Teams and Study Teams.
Maintain knowledge of the global competitive landscape, regulatory environment, regulations and guidance.
Contribute to the development and maintenance of Regulatory Affairs working practices and procedures.
Participates in Business Development efforts, as assigned.

The ideal candidate will have the following:

Develop and implement the US and global regulatory strategies regarding clinical development for assigned projects.
Lead global and/or regional regulatory teams on assigned projects.
Develop and execute US regulatory strategy for clinical development and contingencies for assigned projects.
Serve as the primary interface for FDA on assigned projects.
Communicate project regulatory strategies and plans to management, cross-functional teams and any partners/collaborators to establish alignment.
Lead the preparation of submissions, which may include INDs, Briefing Documents, Orphan Drug Applications, Breakthrough Designation, Pediatric Study Plans, PPSRs, Fast Track Designation and Marketing Applications etc. Work with functional groups to define contributions to submissions. Lead regulatory submission teams for projects assigned.
Prepare company team for FDA and other health agency meetings, as required.
Serve as the primary interface with Regulatory CROs or local regulatory teams globally for coordination and preparation of submissions.
Represent Regulatory Affairs on various cross-functional teams, including Project Teams, Clinical Teams and Study Teams.
Maintain knowledge of the global competitive landscape, regulatory environment, regulations and guidance.
Contribute to the development and maintenance of Regulatory Affairs working practices and procedures.
Participates in Business Development efforts, as assigned.

How to Apply

For further details, please send your CV to: talentacquisition@gandlscientific.com

G&L Scientific is an equal opportunities employer and welcomes applicants from all sections of the community regardless of their gender, religious belief, political opinion, sexual orientation, disability, age, marital status or race.