Senior Director/VP, Regulatory Affairs

Full-TimeCoASan Francisco, CARegulatory Affairs

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CoA Therapeutics, a subsidiary of BridgeBio Pharma, is developing BBP-671, a small molecule allosteric modulator of an enzyme family known as the pantothenate kinases that control coenzyme A synthesis. This therapeutic approach may have utility in diseases associated with coenzyme A depletion, including a rare neurological condition PKAN and inborn errors of metabolism such as organic acidemias.

BridgeBio finds, develops, and delivers breakthrough medicines for genetic diseases. The company bridges remarkable advancements in genetic science with the entrepreneurial engine required to rapidly create lifesaving medicines for patients with unmet needs. Founded in 2015 by a team of industry veterans, the company has built a portfolio of 20 transformative drugs ranging from pre-clinical to late-stage development in multiple therapeutic areas including genetic dermatology, oncology, cardiology, neurology, endocrinology, renal disease, and ophthalmology. The company’s focus on scientific excellence and rapid execution aims to translate today’s discoveries into tomorrow’s medicines. We have offices in San Francisco, Palo Alto, Boston, New York, and Raleigh, with small satellites in other parts of the country. 
 
To learn more, visit us at  https://coatherapeutics.com / www.bridgebio.com

Who You Are:

We are looking for a talented and motivated regulatory affairs leader to develop and execute global regulatory strategies aimed at the most efficient regulatory pathway for a rare disease drug. This role involves collaboration with cross-functional project teams in planning development strategies and leading global regulatory submissions for BBP-671 in the prioritized indications of PKAN and organic acidemia.
Responsibilities:
  • Develop the global regulatory strategic roadmap for BBP-671 across PKAN and organic acidemia indications, including EMA scientific advice and PIP; ODDs and RPDDs; Pivotal planning
  • Liaise primarily with clinical, Nonclinical, CMC, Quality, and patient advocacy members to develop and execute Regulatory strategies aligned with business objectives. Provide guidance, direction, and leadership on those strategies to development teams and executive management.
  • Represent Regulatory Affairs in cross-functional development teams
  • Serve as the primary liaison and prepare teams for meetings with regulatory authorities
  • Participate in the review and approval of essential documents, presentations, and reports
  • Analyze and communicate current regulatory guidance and regulations, as well as industry and regulatory agency best practices and trends, to keep the Company informed on any relevant changes in the regulatory landscape
  • Manage, direct and assist internal staff and regulatory consultants, as required, to ensure compliance of drug development activities with all U.S. and international requirements
  • Perform all duties in keeping with the Company’s core values, policies, and all applicable regulations
Education, Experience & Skills Requirements:
  • BA/BS degree required in biological/physical sciences.  Advanced degree preferred
  • Relevant regulatory leadership experience in the biopharmaceutical industry with demonstrated capability as a successful senior regulatory leader; Minimum requirements are flexible, but ten years of minimum industry experience is generally required
  • Advanced knowledge and experience of US FDA, EMA, and international pharmaceutical guidances, regulations, drug development process, and industry-standard practices
  • Experience in rare diseases and pediatric drug development required
  • Track record for having adopted innovative regulatory strategies for novel molecular entities
  • Proven ability to think strategically
  • Proficient in written, oral, and interpersonal communications
  • Ability to manage complexity and uncertainty
  • Ability to work in a small/mid-sized company within a largely virtual environment; small biotech/pharma experience preferred
  • Experience working on programs with co-development partners
  • Embraces company core values:  1. put patients first; 2. think independently, 3. be radically transparent; 4. every minute counts; and 5. let the science speak
What We Offer:
  • Patient Days, where we are fortunate enough to learn more about the lives we are looking to impact and a real exchange of ideas as to how we can improve our efforts
  • A culture inspired by our values: put patients first; think independently, be radically transparent; every minute counts, and let the science speak
  • Learning and development training to help employees be the best version of themselves
  • Collaborative business environment
  • Excellent compensation package (Base, Performance Bonus, Stock, RSU programs)
  • Excellent benefits package
  • Flexible PTO
  • With office locations in San Francisco, Boston, New York, and Raleigh, there are ample cross-collaboration opportunities with other BridgeBio Pharma programs
  • A fast-paced, data-driven, work environment with world-class R&D minds and capabilities
  • Work with the most productive groups of R&D operators in the industry
  • Partnerships with leading institutions
  • A platform for meaningful scientific contributions to shine
  • Commitment to Diversity & Inclusion – with initiatives like Women at Bridge, we are committed to fostering an inclusive environment where every person feels respected for who they are, empowered to contribute, inspired to lead, and supported in their efforts to do so
We will not accept unsolicited resumes from agencies. Please do not send agency resumes to our website or BridgeBio and affiliating employees.
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Senior Director/VP, Regulatory Affairs

Full-TimeCoASan Francisco, CARegulatory Affairs

Apply Now