Pioneering Medicines | Cambridge, MA Pioneering Medicines: Senior Director, Regulatory Affairs

Flagship Pioneering; Cambridge (MA); On-site; USD 150,000 - 200,000; Full time

Job summary

A leading biopharmaceutical company is seeking a Senior Director of Regulatory Affairs to oversee regulatory strategies for early development programs. The role requires extensive experience in regulatory science and leadership within the pharmaceutical industry.

Qualifications

• Minimum 10 years in Regulatory Affairs lead role.
• Experience with US and EU Regulatory Agencies required.

Responsibilities

• Develop and implement regulatory strategy for clinical development.
• Represent regulatory affairs on Program and Clinical Trial teams.

Skills

Regulatory Science

Leadership

Communication

Education

Advanced degree (M.D., PhD, PharmD, MSc or MPH)

Tools

IND

CTA

Job description

Pioneering Medicines: Senior Director, Regulatory Affairs

Cambridge, MA USA

What if... We could harness the power of Flagship’s scientific platforms and create novel treatment options that benefit more patients, sooner?

Pioneering Medicines, an initiative of Flagship Pioneering, is building a world-class biopharmaceutical R&D capability focused on conceiving and developing life-changing treatments for patients by harnessing the power of Flagship's scientific platforms and applying those innovative approaches to serious diseases with unmet medical need. Unique to Pioneering Medicines’ approach is the opportunity to combine platforms to create truly novel and potentially transformative treatments.

About Flagship Pioneering:

Flagship Pioneering conceives, creates, resources, and develops first-in-category life science platform companies to transform human health and sustainability. Since its founding in 2000, the firm has originated and fostered the development of more than 100 scientific ventures, resulting in over $34 billion in aggregate value, 500+ issued patents, and more than 50 clinical trials for novel therapeutic agents.

Position Summary:

Pioneering Medicines is seeking a curious, driven Senior Director, Regulatory Affairs with pharma/biotech experience to support Clinical Development for one or more early development programs. Experience in early phase clinical development is essential. This role is responsible for generating the regulatory strategy and approval for novel pharmaceuticals that are going into clinical trials. This role will collaborate across groups within Pioneering Medicines and with Flagship and pharma partner companies and CROs. This leader will deliver regulatory strategies for a growing pipeline of diverse assets in the PM portfolio, with an emphasis on programs transitioning to the clinic and in early development. This individual will also provide input into clinical development for early asset companies and explorations within the Pioneering Medicines’ portfolio and to companies across the Flagship Ecosystem, as needed. This individual would report to the SVP of Project Leadership and Development, Pioneering Medicines

The preferred candidate will have expertise in multiple therapeutic areas, including metabolic diseases and obesity, and drug modalities and have led regulatory filings for IND and/or CTA opening studies. Experience with end of phase meetings and successful NDAs or BLAs is a plus. They must possess a strong background in regulatory science, regulatory intelligence, have demonstrated leadership skills, an entrepreneurial spirit, and a compulsion to be challenged every day.

Key Responsibilities:

• Work with the SVP of Project Leadership and Development, the Development Project Lead/Clinical Lead and other company leaders, as well as program and clinical trial teams, to develop and implement regulatory strategy, development plans and associated activities across our innovative pipeline.
• Represent regulatory affairs on Program teams and Clinical Trial teams - owning regulatory timelines and process, and the application of appropriate regulations and guidance .
• Plan and execute successful engagements, including pre-IND/CTA and other scientific advice meetings, with regulatory agencies and serve as the primary contact for PM with the FDA and other regulators.
• Provide regulatory guidance to project teams from product concept stage through human proof of concept trials, including strategic considerations, building timelines, regulatory submissions, and risk assessments and mitigations.
• Own the development of asset-specific Regulatory De velopmen t Plan s , author and manage c reation of IND/CTA & Briefing Books, drive pre-IND meeting s and other Health Authority-facing interactions related to specific clinic al trials.
• Develop and maintain current regulatory intelligence knowledge, including evolving policies and emerging guidance, and disseminate to project teams and PM management.
• Drive the development of regulatory policies, processes, and SOPs for PM and help establish a compliance-focused culture.
• Participate in the evaluation of assets across the FSP landscape for the PM pipeline and assist teams to present findings and recommendations to our Development Committee.
• Leverage regulatory affairs expertise to assist nascent FSP platform companies to develop their asset portfolio.
• Maintain and interact with an effective network of outside partners, key opinion leaders, consultants, and CRO and strategic consulting organizations to drive programs forward.
• Prepare and deliver presentations for external and internal audiences, as needed.

Minimum Qualifications:

• Advanced degree (M.D., PhD, PharmD, MSc or MPH) with a focus in pharmaceutical sciences, including a minimum of 10 years of pharmaceutical/biotechnology industry experience in Regulatory Affairs lead role with hands-on regulatory experience in all aspects of regulatory affairs.
• Regulatory Affairs Certification (e.g., RAC) is desirable.
• Experience working with US and EU Regulatory Agencies is required; experience with clinical trials in Australia and/or New Zealand is desirable.
• Knowledge and experience in interpretation of FDA, EMA and ICH regulations, guidelines, and policy statements.
• Preparation of major regulatory submissions (e.g., IND, CTAs) and supportive amendments or supplements for early-stage development programs, including both clinical and pre-clinical aspects of projects; direct experience interfacing with regulatory authorities.
• Prior experience in a combination of metabolic diseases and/or immunology drug development is ideal, and experience in rare diseases is a plus.
• Experience with two or more of the following modalities is required: small molecules, biologics, peptides, nucleic acids, or cell therapies; with experience in novel modalities (e.g., gene editing, RNAi, gene therapy) desirable.
• Experience and comfort with a fast-paced biotech company environment.
• Proven ability to foster effective, positive interactions with regulatory agencies, and corporate partners.
• Demonstrated leadership, communication, collaboration, and organizational skills.
• Ability to travel domestically and internationally, as required.

About Flagship Pioneering:

Flagship Pioneering conceives, creates, resources, and develops first-in-category life science platform companies to transform human health and sustainability. Since its founding in 2000, the firm has originated and fostered the development of more than 100 scientific ventures, resulting in over $34 billion in aggregate value, 500+ issued patents, and more than 50 clinical trials for novel therapeutic agents.

Flagship Pioneering and our ecosystem companies arecommitted to equal employment opportunityregardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity or Veteran status.

Recruitment & Staffing Agencies: Flagship Pioneering and its affiliated Flagship Lab companies (collectively, “FSP”) do not accept unsolicited resumes from any source other than candidates. The submission of unsolicited resumes by recruitment or staffing agencies to FSP or its employees is strictly prohibited unless contacted directly by Flagship Pioneering’s internal Talent Acquisition team. Any resume submitted by an agency in the absence of a signed agreement will automatically become the property of FSP, and FSP will not owe any referral or other fees with respect thereto.

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