Working at Altavant

Altavant is an equal opportunity employer. All qualified applicants will be considered without regard to age, race, color, sex, religion/creed, national origin, marital status, ancestry, citizenship, military, reservist or veteran status, pregnancy, sexual orientation or preference, gender identity, gender expression, physical or mental disability, genetic predisposition or carrier status, or any other category protected under applicable federal, state or local law.

See current job openings at Altavant Sciences below.

Head of Regulatory 

Primary Role

In this role, you will lead development of all non-clinical, clinical, and commercial regulatory strategies including management of IND, NDA, and BLA submissions, FDA and other regulatory interactions, as well as international submissions. In addition, this role is responsible for building and managing regulatory operations and medical writing teams / consultants. 

  • Serve as global regulatory head and provide regulatory guidance and strategy, including identifying and assessing regulatory risks for non-clinical, clinical and commercial development plans and activities.
  • Lead strategy and development of regulatory non-clinical, clinical submissions in conjunction with project teams.
  • Assess regulatory project plans and timelines and ensure all projects are appropriately prioritized and key goals are met on time
  • Oversee the preparation of meeting requests and briefing documents, and plan, execute and lead the coordination and preparation of teams for health authority meetings.
  • Oversee compilation, electronic processing and publishing to ensure high quality and timely electronic submissions compliant with regulatory authority requirements.
  • Serve as primary company representative to regulatory agencies to ensure the review and approval of development plans, the timely resolution of issues, and the approval of marketing applications.
  • Advise senior leadership and project teams on status of US and global regulatory affairs strategies and tactics, procedures and practices and impact on the development and approval requirements.
  • Oversee the maintenance and creation of relevant SOPs, Work Instructions and other necessary guidance.
  • Support department budget and ensure operations are within the approved budget and timeline.
  • Provide leadership and direction to staff, consultants, and vendors supporting regulatory affairs. Manage workload, train staff and effectively allocate resources.

Education and Experience Requirement

  • Advanced degree, PharmD, or PhD preferred with a minimum of 10 years related experience
  • Previous experience as regulatory head or lead for a product in clinical development
  • Proven experience in developing strategies and submitting applications for small molecule or biologic products (INDs, NDAs, BLAs)
  • Knowledge of global regulations and guidelines (nonclinical, clinical, labeling, promotional)

Other Job Requirements

  • Positive attitude and willing to roll up her/his sleeves to get the job done; ability to pay close attention to detail and step back and think strategically
  • Strong interpersonal verbal, written and presentation skills in communication with internal and external parties
  • Nonstandard working hours and domestic / international travel will be required periodically

Head of CMC 

Primary Role

  • Establishes and oversees implementation of the overall CMC strategy for all products in development stages ranging from lead optimization and preclinical studies through global Phase 3 clinical trials, registration batches, and process performance qualification.
  • Develops, oversees, and takes responsibility for CMC operational budgets and resource planning to meet business objectives.
  • Negotiates and administers contracts with key contractors, consultants, suppliers, and contract manufacturing organizations. Performs on-site visits as needed to key suppliers globally.
  • Prepares and reviews Technical/Quality Agreements to ensure that outsourced activities are conducted in compliance with cGMPs and exercise appropriate oversight of these activities.
  • Develops long-term strategies to establish a robust commercial supply chain, enact appropriate risk mitigation procedures, monitor and identify future market trends.
  • Works with company leadership to build internal CMC team and ensure team has appropriate skills, capabilities, and resources to meet current and future business needs.
  • Ensures all development, manufacturing, and process performance qualification activities are completed in accordance with quality and regulatory expectations to support relevant global regulatory submissions.
  • Participates in regulatory CMC strategy development, identifies gaps, and proactively provides risk mitigation strategies for the regulatory submissions required for clinical trial and marketing applications.
  • Reviews, edits and provides input into CMC regulatory submissions (e.g., IND, CTA, NDA, and MAA, BLA).
  • Participates in and represents CMC in meetings with global regulatory agencies.
  • Discusses and presents CMC information and manufacturing plans/updates to internal teams and business partners, as required.
  • Builds and maintains strong relationships with all external and internal stakeholders, including alliance partners, to ensure that performance targets are met or exceeded.

Education and Experience Requirement

  • PhD in chemistry, pharmaceutical sciences, chemical engineering, or a related discipline with at least 15 years of pharmaceutical drug synthesis and scale up, pharmaceutical product design and process development
  • Demonstrated experience with at least one or more of the following: small molecule solid oral dosage forms, inhaled compounds, and biologics.
  • Leadership experience over a team of CMC scientists and/or engineers, leading cross-functional projects, and delivering results within tight project deadlines.
  • Experience managing within a virtual manufacturing environment or a smaller biotech organization is preferred.
  • Demonstrated ability to select and manage CMOs for pilot-scale through commercial manufacturing, including contract negotiation.
  • Demonstrated expertise in taking a product through to commercial launch.
  • Proven understanding of US, EU, and other global regulations and requirements.
  • Experience in authoring CMC documents for regulatory submissions and solid understanding of pharmaceutical development, quality, and regulatory issues associated with product approvals.

Other Job Requirements

  • Positive attitude and willing to roll up her/his sleeves to get the job done; ability to pay close attention to detail and step back and think strategically
  • Strong interpersonal verbal, written and presentation skills in communication with internal and external parties
  • Nonstandard working hours and domestic / international travel will be required periodically