Director of Regulatory Affairs

4 weeks ago

San Antonio, United States Evestra, Inc. Full time

Our Company:

Evestra, Inc. is an emerging biopharmaceutical company that focuses on developing and commercializing women’s healthcare products. Based in San Antonio, Texas, Evestra’s mission is to improve the health and well-being of women around the world through innovative technologies and products.

Responsibilities:

  • Develop and oversee regulatory strategies for clinical trials in alignment with US and European regulatory requirements and industry standards.
  • Lead and author the preparation and submission of regulatory documents to the FDA and EMA, including IND/CTA filings, to ensure compliance with regulatory agencies.
  • Provide strategic guidance on global regulatory requirements throughout the clinical trial lifecycle, from study design to data submission.
  • Serve as the primary point of contact for regulatory inquiries from internal teams, sponsors, and regulatory agencies.
  • Provide leadership and mentorship to company, fostering a culture of compliance and continuous improvement.
  • Collaborate with clinical operations, data management, and other functional areas to ensure regulatory requirements are integrated into clinical trial processes.


Qualifications:

  • Advanced degree in a relevant scientific or regulatory field (e.g., life sciences, pharmacy, regulatory affairs).
  • At least 10+ years of experience in regulatory affairs, with a focus on clinical trials, must be in the pharmaceutical or biotechnology industry.
  • Demonstrated accomplishments in achieving successful outcomes with regulatory interactions.
  • Proven track record of successful regulatory submissions and interactions with regulatory agencies.
  • Strong leadership skills with experience managing teams and driving cross-functional collaboration.
  • Excellent communication and interpersonal skills, with the ability to effectively engage with internal and external stakeholders.
  • Detail oriented with strong analytical and problem-solving abilities.
  • Ability to thrive in a fast-paced, dynamic environment and adapt to changing priorities.



The above is intended to describe the general content of and requirements for the performance of this job. It is not to be construed as an exhaustive statement of duties, responsibilities, or physical requirements. Nothing in this job description restricts Management’s right to assign or reassign duties and responsibilities to this job at any time. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

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