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Vice President RA
- Provide regulatory advice to the executive management team to support the strategy of the company.
- Define regulatory strategies for the company’s development portfolio.
- Identify regulatory requirements for development projects to obtain marketing authorizations.
- Steer and manage the regulatory activities and interactions with regulators i.e. FDA, including pre-INDs, INDs etc., NDA and ANDA submissions. Organize EU and ROW submissions.
- Contribute regulatory expertise to R&D project teams.
- Lead, manage and develop the RA team.
- Work as a strong partner with the COO, the Executive Management Team, the Board, and external scientific advisors to manage and advise on scientific aspects of proposed business strategies.
- Act as a key member of the Management Team and provide high-level and high-quality strategic advice to the executive management and the business development department to support the strategy as well as day-to-day operational decisions.
- Provide assessment of regulatory competency of CDO’s, CRO’s, CMO’s and CTO’s.
- Undertake or delegate the complete RA process, from project nomination until regulatory approval.
- Undertake or coordinate detailed regulatory and scientific content-review of dossiers for submission to Authorities. The scope of the review includes areas related to formulation, analytical method suitability and testing, stability evaluation including trend analysis, and manufacturing through packaging.
- Provide advice and gaps analysis during product development, tech transfer and lead the teams for dossier compilation, responses to deficiencies, and post-approval changes.
- Detailed review of NDA 505(b)(2) or occasionally ANDA dossiers in accordance with US FDA standards of acceptability and essential completeness of eCTD modules (Modules 2, 3 & 5).
- Oversight of dossiers to enable Acceptance to File (ATF), avoidance of Refuse-to-Receive (RTR) from FDA and confirm overall robustness of the dossiers.
Regulatory process development, implementation, improvement, and execution
- Develop and document principles for pragmatic, business focused, efficient and balanced RA strategies for all new projects considering the project value, project cost and the current regulatory environment, including latest changes and trends and their impact.
- Develop and implement business-oriented strategies to optimize the quality of and speed of development projects from a regulatory compliance perspective.
- Ensure scientifically and independent rigorous review of all documentation generated and throughout their course and implement ongoing improvements and refinement of processes to support the performance (time, cost and quality) of projects.
- Supervise external manufacturing and development partners on matters related to RA.
RA team management
- Undertake direct responsibility of the RA team and provide strong leadership in organizing the team, workload, laying out clear roles and responsibilities, training, mentoring, evaluating performance and recruiting according to the company strategy and values.
- Provide day-to-day supervision to the teams and provide specific solutions and advice to address challenges and hurdles encountered during the execution of development programs.
- Establish training programs to engage colleagues and improve the project efficiency and quality.
- Supervise, coach and mentor new members of the team.
Skills and personality
- Minimum Qualification: Master’s degree or higher in Science or related field.
- Minimum Experience:
- Minimum 15 years of experience with regulatory affairs in the US and at least 5 years of experience in CMC review of scientific aspects required for compiling data on pharmaceutical products for ANDA 505(b)(2) and potentially ANDA submissions.
- Deep understanding of current regulatory requirements related to Quality by Design, manufacturing process mainly for injectable products, analytical development, validation and testing, stability evaluation, etc., and
- Thorough understanding of the dynamic regulatory environment in the US, including prompt awareness of new guidance, draft guidance, trends and the current thinking of the FDA it ability to translate this environment into specific actions for each development project of the company
- A strong scientific track record of delivering key development milestones, leading to NDA/ANDA filings and approvals within the agreed timelines.
- Languages: English. French or Dutch is an asset.
- Strong skills in chemistry and drug product formulation as well as robust knowledge of manufacturing facilities, manufacturing technologies and equipment, their suitability and limitations, mainly in the injectable field.
- Strong analytical skills, good negotiator/diplomat, enabler.
- Strong interpersonal skills, a collaborative and trust enabling working style, building partnerships among key stakeholders.
- Strong track record with the FDA processes and requirements for 505b2 NDA submissions including pre-IND submissions, IND, and clinical matters.
- Organizational aptitude to build, lead and develop an outstanding team.
- Adaptability, flexibility, independence, and resourcefulness to both lead a big vision strategy while also willing to roll-up-sleeves and multi-task in order to thrive in a growing environment.
+- 10 year to 20 years
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