Our client is a clinical stage biopharmaceutical company. They have asked us to assist them in their search for a Senior Vice President, Regulatory Affairs.  

Major tasks and responsibilities include:

• Develops and executes global regulatory strategies that encompass multiple regions and countries, ensuring alignment with international regulatory requirements.
• Stays up to date with emerging regulatory trends, guidelines, and changes in the regulatory environment and adapts the organization’s strategies accordingly.
• Keeps executive leadership team informed of regulatory status and significant regulatory issues and is accountable for all regulatory functions from pre-IND to post-marketing responsibilities.
• Collaborates with executive leadership to align regulatory strategies with overall corporate goals and objectives.
• Leads the Regulatory Affairs team to design and execute regulatory strategy for approval and commercialization of the company’s products, including preparation, review, and submission of appropriate background documents and regulatory submissions.
• Represents regulatory on cross-functional teams and partners with other senior management leaders to create integrated lifecycle management strategy to maximize portfolio value and ensure alignment with company objectives.
• Presents regulatory strategies to internal teams and influences internal and external customers as necessary to ensure successful implementation in support of corporate business goals.
• Leads interactions with project team members, consultants, and regulatory authorities to ensure regulatory paths are clearly defined and milestones are met leading to successful filings and approvals.
• Contributes to the development of the overall nonclinical and clinical development strategy by providing regulatory insights and guidance at all stages of product development.
• Seeks innovative and creative operational solutions that comply with regulations and are sound from business and scientific perspectives. Provides contingencies and alternate approaches to leadership and/or partners to resolve any development program challenges from preclinical (pre-IND) to Phase 1 through approval.
• Manages and leads interactions with FDA/EMA/UK health authorities and other authorities as appropriate.
• Reviews documents and provides regulatory guidance for clinical protocols, investigator brochures, informed consents, and other GCP documentation.
• Prepares and oversees clinical trial applications, amendments, meeting briefing documents, and applications for orphan drug or special status.
• Works with Regulatory Operations to ensure e-submissions are complete and technically compliant in accordance with eCTD specifications.
• Serves as regulatory lead and primary point of contact for CMC team interactions with regulatory agencies.
• Works with Clinical Team to review and contribute to IB updates.
• Aligns with pharmacovigilance for safety reviews and core data maintenance.
• Working closely with the Quality function, establishes or re-engineers SOPs, as needed.
• Monitors and communicates regulatory changes and enforcement activities.
• Estimates resource needs and identifies, onboards, and manages resources.
• Oversees Regulatory affairs budget, including resource allocation, cost control, and budget forecasting.

We seek candidates with the following qualifications:

• A Bachelor’s degree is required. Must have significant experience leading regulatory strategy with health authorities. 5 years of experience must involve clinical development strategy. Global regulatory experience is required.
• Experience with rare disease/neuromuscular/neurodegenerative therapies is required, including experience interacting with the neuro division of the FDA.
• Must have the demonstrated ability to develop and execute long-term regulatory strategies that are aligned with the organization’s overall business objectives.
• Must be highly proficient in communicating and presenting strategic and tactical issues to all levels, including top management and regulatory agencies.
• Must have experience representing company regulatory affairs function to internal and external stakeholders.
• Requires demonstrated leadership and motivation of staff to successfully execute regulatory strategies and resourcefully direct the development of creative solutions to complicated regulatory and systems challenges.
• Must have a track record of successfully setting regulatory strategy, product registrations, and regulatory filings (IND, NDA, and other similar regulatory filings) with FDA and ex-US agencies including MHRA and EMA.  Experience with global applications and change control is required.
• Superior writing and verbal communication skills are required.
• Must have demonstrated project management skills and organizational skills.
• Must be self-motivated, self-driven with a proactive work style and the ability to initiate follow-through on assignments.
• Must be willing to roll up sleeves and be hands-on.
• Must embrace collaboration across departments.
• Requires the ability to effectively identify, prioritize, and solve problems.
• Must be able to effectively recommend and implement solutions to problems.
• The ability to articulate examples of how quality is essential to drug development is required.
• Must be able to effectively use MS Word, Excel, flowcharting programs, PowerPoint.

If interested, please apply directly to this job posting. No calls please. Include your daytime phone number and we will contact you confidentially or reply to your email.

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