Director of Regulatory Affairs
Director of Regulatory Affairs
Aeglea BioTherapeutics, Inc., is an Austin, TX, based biotechnology company committed to developing engineered human enzymes for the treatment of rare diseases and cancers associated with abnormal amino acid metabolism. The company’s recombinant human enzymes are designed to degrade specific amino acids in the blood in order to reduce toxic levels of amino acids in rare diseases or to starve tumors dependent on amino acids by reducing levels below the normal range. Aeglea’s initial clinical program for its lead product candidate, AEB1102, includes clinical trials studying AEB1102 for the treatment of patients with Arginase 1 deficiency as well as patients with solid tumors or hematological malignancies. The company is also building a pipeline of additional product candidates targeting key amino acids.
The Director of Regulatory Affairs provides strategic direction, oversight and management of assigned Regulatory Affairs functions, aligning department and project objectives with overall pipeline objectives and tailoring them to the appropriate needs of Aeglea BioTherapeutics and its partners. The Director of Regulatory Affairs reports to the Vice President of Regulatory Affairs, collaborates with line management, and is responsible for managing Regulatory direct reports and/or contractors.
Essential Duties and Responsibilities: To perform this job successfully, an individual must be able to perform the following:
- Build and manage Regulatory Affairs with internal employees and when necessary identify other experts, consultants and CROs to engage with the company and project teams.
- Act as the subject-matter expert on assigned Regulatory Affairs activities. Lead regulatory assignments with a sense of urgency and a commitment to patients so our drug candidates will be developed and commercialized as quickly as the data and regulators allow.
- Participate in cross-functional teams in preparing development plans, while monitoring and tracking activities relevant to regulations. Ensure all nonclinical and clinical regulatory programs (e.g. pharmacology, toxicology, Phase 1-4 clinical trials) and all technical programs (e.g., stability program, manufacturing development program, validation plans, labeling, etc.) relevant to the chemistry, manufacturing and controls of pharmaceutical products are appropriately structured to meet US and ex-US regulatory requirements.
- Ensure that Aeglea’s Regulatory Affairs staff develop and maintain databases, documentation and records regarding global regulatory statutes, regulations, processes and precedents to ensure advice and planning decisions are based on current and accurate information.
- Compile, edit, prepare and manage preparations of final Regulatory submissions, including oversight/leadership of appropriate support staff. This includes writing introductory or bridging sections and conclusions to produce and submit a complete, cohesive and professionally prepared document (NDAs, BLAs, INDs, CTAs, annual reports, protocol amendments, adverse event reports, notifications, and other reports) in accordance with global regulatory procedures and guidelines to meet the company’s business objectives.
- Lead, guide and collaborate with other development departments and external partners (including their selection of and oversight) in writing reports and summaries. Support the VP of Regulatory Affairs and Quality in managing and leading other staff to ensure they meet regulatory requirements in structure, data and presentation as needed.
- Maintain current knowledge of company philosophies, plans and processes in the following areas: financial planning and reporting, human resources planning and leadership, project planning, management and reporting.
- Support the VP of Regulatory Affairs in leading regulatory communications with external stakeholders, development and business partners (e.g., investors, legal, nonclinical, statistical, market access specialists and vendors and consultants).
- Represent the Company’s Regulatory Affairs programs in discussions with external individuals or entities that may audit, review or examine Company’s efforts in this area.
- Collaborate with a variety of internal and external technical and medical experts to provide input into and support to Aeglea’s drug research and development pipeline.
- Support the VP of Regulatory Affairs in performing due diligence, and educate internal staff accordingly. Assign direct reports to the project teams to ensure consistent implementation of regulatory and quality strategies for products throughout the lifecycle of a product.
- Support the VP of Regulatory Affairs in developing and adhering to functional area operational budgets for all programs.
Education/Experience: The ideal candidate will offer:
- Advanced degree in regulatory science, life sciences, or the law
- 7+ years in a senior management role within a regulatory or quality, preferably in the biotechnology and/or pharmaceutical industries.
- A solid history of bringing small molecule or biologic oncologics to IND/CTA phase and BLA/NDA/MAA submission phases and commercialization. Experience negotiating pivotal trial endpoints with FDA, conducting successful SAWP meetings with the EMA, and negotiating country-specific strategies with other national health authorities as appropriate (e.g., Japanese PMDA). Proven ability to provide regulatory leadership and expertise within a cross-functional, team-based environment.
Knowledge, Skills and Abilities:
- Excellent written and verbal communication skills and demonstrated ability to build relationships and act as liaison with regulatory agencies and partners on drug development matters.
- Industry veteran with strong relationships across regulatory sector.
- Extensive regulatory background with demonstrated ability to work with the FDA, EMA, and other health authorities worldwide, including preparation of regulatory submissions in multiple (non-English speaking) European jurisdictions.
- Prior responsibility and accountability for regulatory and quality strategy, development and implementation of all regulatory policies, quality programs, document control, training and auditing programs.
- Extensive experience in the organization, preparation, submission and negotiation of INDs, CTAs, DMFs, BLAs, NDAs, and MAAs for oncologics.
- Independent, self-motivated with a highly entrepreneurial style coupled with self-confidence and a positive demeanor.
- Hands-on manager able to deal with pressures and timelines inherent in an ambitious company that is driving its’ programs through to completion.
- Decisive and willing to take charge in developing consensus without alienating others. Must have strong team working skills and be able to work across many organizational units equally well.
- Develops an effective and collaborative working environment for both direct reports and extended team members. Plays a key role in maintaining a strong partnership between all functional areas.
- Must possess skills which span science and a business acumen that instills confidence and pride throughout the Company.
- Regulatory experience in rare disease or oncology, and other relevant therapeutic areas.
- A “make it happen” attitude, along with a strong commitment to teamwork and initiative.
- Ability to wear many hats, be productive and deliver on responsibilities.
- Well-developed critical reasoning skills and in risk management assessments
This is a high growth, fast paced small organization. The ability to be productive and successful in an intense work environment is critical. Willingness and ability to travel domestically and internationally on occasion is required, it is anticipated that this will be less than 10% of work time.
Physical Demands: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
The above job description is not intended to be an all-inclusive list of duties and standards of the position. Incumbents will follow any other instructions, and perform any other related duties, as assigned by their supervisor.
We recognize that our commitment to patients only comes to life when employees are a priority, as well. This translates into our culture and our generous benefits package including medical, dental, and vision coverage, a 401(k) program as well as an Employee Stock Purchase Plan (ESPP). And we know that sometimes, it’s the small things that can really make a difference. Our employee perks include a corporate gym reimbursement program, an assortment of provided snacks, weekly free lunches and social hour.
We are looking for exceptional individuals who connect with our credo, bring tremendous skills and talent with their experience, and are willing to roll up their sleeves and work hard to change the lives of patients. If this sounds like you, we’d love to hear from you.