Who We Are:

Antheia is a science and technology company developing next generation plant-inspired medicines. Applying synthetic biology, genomics, bioinformatics, data science, and fermentation, we harness the most beneficial molecules from plants to create active pharmaceutical ingredients in more controlled and economical ways. We are a close-knit team inspired by the possibilities of delivering transformative technologies and breakthrough science to change the course of medicine. We value our people as our most important resource and are always looking for talented individuals who can make valuable contributions to our efforts.

 About the Job:

The Senior Manager of Regulatory Affairs will provide management, overall strategic direction and operational coordination of activities for the regulatory affairs function, and additionally be responsible for obtaining and maintaining government approval for drug substances and drug products. The Senior Manager of Regulatory Affairs will ensure compliance for submissions and regulatory communications with the FDA, EMA and other country specific organizations.  The role will require general knowledge of QSR, ISO and other applicable global regulatory.

 What You Will Do

  • Manage preparations of regulatory submissions required for key starting materials (KSM), API and Drug Products as well as registrations in the US and EU (and globally as necessary).
  • Correspond and collaborate with Antheia colleagues for strategic contributions and achievement of regulatory milestones.
  • Conduct evaluation of program/product activities and assumptions on regulatory expectation for both Antheia as well as downstream customers. Evaluations to be based on known regulatory guidance and expectations.
  • Function as the Regulatory Affairs subject matter expert on applications and submissions in both the US as well as EU including DMF, PSA, BLA, MAA, DEA and REACH as possibilities.
  • Function as the primary contact with US and EU agencies for matters related to the import, export and registrations requirements for Controlled Substances.
  • Function as the direct liaison with US and EU Regulatory agencies.
  • Perform regulatory research to inform business strategy. Provide guidance to Antheia based on the understanding of requirements from FDA 21 CFR Part 210/211 as well was EU GMP Volume 4 Annex I and II
  • Assure that there are no significant interruptions to the business due to regulatory compliance issues.
  • Work within a high performing team of Quality Assurance, Operations and Development professionals to manage business goals and objectives.
  • Provide regulatory program leadership for Antheia manufacturing processes and regulatory risk.
  • Collaborates across the organization at all levels, across functional groups, and with executive management.
  • Work independently while communicating and reporting regularly to Quality Assurance and Regulatory Management.
  • Direct and oversee the regulatory planning processes; participate in strategic and tactical planning processes.
  • Develop regulatory strategies to inform associated budgets, tools and specialized support necessary for efficient operations.
  • Lead employee development, communication and necessary regulatory training programs in connection with the company's strategic goals and compliance objectives.

Qualifications and Experience

  • Bachelor's Degree with 10+ years of direct Regulatory experience OR
  • Master’s degree in field with 8+ years of related work experience
  • Strong independent regulatory submissions development experience
  • Strong working knowledge of US FDA Pharmaceutical regulations and guidance
  • Strong working knowledge of EU EMA Pharmaceutical regulations and guidance
  • Proven track record of successful submissions within a regulatory environment
  • Ability to work in a regulated environment in compliance to ISO 9000, 21 CFR 210/211 and EMA Annex I & II
  • Exceptionally strong team player with excellent interpersonal and communication skills, and experience working with end-users in a mentoring capacity
  • Detail-oriented with strong organizational skills and high quality standards
  • Experience managing changing conditions, processes and approaches; lead organizations through change effectively.
  • Pharmaceutical industry experience, in a controlled environment
  • Proven knowledge of US FDA and EU EMA and ISO requirements
  • Partner with team members to inform on strategic goals and objectives from knowledge base and understanding of the business.
  •  

Preferred Qualifications

  • 5+ years of regulatory leadership experience in managing complex regulatory environments.
  • Training and certificates in quality or regulatory affairs (e.g. RAPS, CQM, CQE, CQA, RAC, CLIA)
  • Experience in supporting Pharmaceutical Manufacturing Operations
  • Experience with biologic processes of manufacturing.

Additional Information

Full-time base salary range of $140,800 –$175,000, plus an annual bonus potential and equity opportunities.

 

Antheia’s compensation and benefits include:

  • Comprehensive compensation package, which includes annual bonus potential and equity opportunities
  • Paid time off, in addition to company-observed holidays
  • Excellent medical, dental, and vision insurance
  • 401(k) retirement savings plan
  • Free access to the Menlo Park Labs Gym
  • Menlo Park Labs free shuttle service to CalTrain, BART Station, and SF

 

Antheia is an equal opportunity employer and does not discriminate based on race, color, religion, marital status, age, national origin, ancestry, physical or mental disability, medical conditions, veteran status, sexual orientation, gender (including gender identity and gender expression), taking or requesting statutorily protected leave, or any other basis protected by law. In addition, Antheia prohibits the harassment of any individual on any of the bases listed above or any other characteristics protected under federal, state, or local laws.

Legal authorization to work in the United States is required. In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment eligibility verification form upon hire.

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