Associate Director, Regulatory Affairs Strategy
$1 to $2 Per Year
- Responsible for parts of global regulatory strategies and global submission plans for QM1114, and any newly identified toxins: builds and maintains a global regulatory strategy plan; assures relevant input is vetted and included in the regulatory strategy in order to deliver on the Target Product Profile, regional specific needs, regulatory environment, regulatory risks and mitigations, and global submission strategies. Follows (and executes necessary tasks) regulatory strategic leadership for development projects including health authority interactions (e.g. FDA but not only), regulatory submissions (e.g. IND, CTA, MAA, BLA, NDA) and other regulatory requirements in line with corporate objectives, timelines and budgets.
- Manages the new registrations of Toxins globally: be the FDA contact person for US and coordinates preparation and submission globally - identifies and assess risks associated and proposes mitigations plans accordingly
- Prepares and coordinates documents to answer Health Authorities questions and submit to HA if applicable (US) ; close follow-up of the dossier review with affiliates ; has an overview of all on-going procedures and communicates the status to management / identified stakeholders
- Member of QM 1114 GRT: responsible for parts of global regulatory strategy & submission plans for QM1114
- Support regulatory activities for any toxins not directly registered by company where company acts as distibutor
- Coordinate regulatory CMC strategies with RA CMC
- Accountable for US regulatory strategy
- Identify and assess risks associated with product development and recommend strategies to mitigate these risks
- Ensure strategic regulatory input is provided to key development activities and documents, including clinical, non-clinical, and CMC development documentation as needed
- Manages dossier renewals for assigned products globally: activities include (but not limited to) regulatory strategy, dossier preparation with coordination of adequate Subject Matter Experts (such as for addendum of clinical overview), coordination of answer documents in case of HA questions, follow-up of the approval
- Ensures that all regulatory documents are prepared and tracked in EDMS and that all regulatory activities are tracked in the regulatory affairs database
- Initiates, reviews and contribute to SOPs, forms, etc. to support regulatory development processes.
- Anticipates, contributes to improvements to processes and to ensure continued compliance with applicable regulations.
- Monitor internal and professional communications concerning relevant regulations (FDA, ICH, EMA, …) in close collaboration with affiliates
- Prepare ad-hoc summaries and communication tools to inform relevant stakeholders / management
- Act as valuable member of the Global Regulatory Teams for Toxins / QM 1114
- Responsibility for ensuring collaboration with key internal stakeholders of GRA
- Participate to QM1114 RA budget and team activities, as needed
- Accountable for management of outside vendors as needed
BSc in a Scientific discipline Required. MSc, or PhD in a Scientific discipline, or PharmD, Preferred.
Knowledge and understanding of regulatory requirements for pharmaceutical/biological product development and approval in more than one key region (ie. US, and EU)
Experience with communicating the regulatory strategy, issues, and risks in written and verbal format to regulatory senior leadership team and other governing bodies
Experience interfacing with regulatory agencies and skill at implementing successful global regulatory strategies
Experience with documenting regulatory strategies in coordination with clinical plans and marketing objectives.
Excellent team interaction skills along with demonstrated ability to work on a cross-functional team
Experience with international project management
Focused on effective delivery of objectives, even when working with tight deadlines
Ability to identify opportunities/major issues and to communicate impact
Demonstrated ability to deal with rapid change
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