Manager/Associate Director/Director, Regulatory Affairs
2 weeks ago
EXECUTIVE DIRECTOR; REGULATOR AFFAIRS
POSITION: Executive Director, Regulatory Affairs
LOCATION: San Diego, CA; On-Site/Hybrid; Full Time
Redeployment was created to match great people with great Life Science companies We have been hired by a San Diego based company that is developing innovative therapies that will bring about sustainable life-changing benefits to cancer patients to identify candidates to an Executive Director of Regulatory Affairs position.
This executive will lead the Regulatory Affairs Group at the client company reporting directly to the Chief Medical Officer. They will be well versed in speaking to internal and external stakeholders, as well as being a leader within the company, thriving in a fast-paced, innovative startup environment.
ROLES AND RESPONSIBILITIES:
Lead the Regulatory Affairs group, acting as the primary strategic contact with the FDA and other regulatory agencies.
Develop and execute strategic plans for the creation and submission of regulatory documents, including INDs, NDAs, CTAs, MAAs, supplemental NDAs, protocol amendments, and fast track designations.
Collaborate closely with clinical development, nonclinical, drug discovery, and legal teams to optimize strategies for portfolio growth and program advancement.
Develop and establish a regulatory organization, along with processes and procedures, based on a deep understanding of current and future regulatory policies.
Build and resource the Regulatory team, providing leadership, managing performance, and developing team members. Oversee hiring and integration of new staff.
Provide expertise in interpreting FDA regulations, offering guidance and training to other functional groups and executive management.
Establish best practices and drive the creation of standard operating procedures and work instructions.
EDUCATION AND EXPERIENCE:
REQUIRED:
Bachelors degree in a scientific or related field.
10+ of experience in the pharmaceutical/ biotechnology industry, mainly in Regulatory Affairs
Regulatory experience working in oncology and hematological malignancies
Deep understanding of the global pharmaceutical drug development and regulatory environment, particularly within the FDA.
Strong communication skills with the ability to build cross-functional relationships and work collaboratively.
High attention to detail with the ability to work independently, within a multidisciplinary team, and with external partners and vendors.
Prior experience in people management and in identifying organizational needs (talent, process, technology).
Experience interacting with the FDA and other regulatory authorities, including preparation for and participation in FDA advisory committee meetings.
Excellent oral and written communication skills, with the ability to articulate complex situations clearly and meet regulatory documentation standards.
PREFERRED:
Graduate level education (MS, PhD, PharmD, MD)
Extensive Oncology experience
Successful IND submissions, clinical trials, and examples of bringing drugs through the clinical process from beginning to end.
Relationships and contacts across industry and with the FDA.
BENEFITS:
Salary/Compensation: $240K - $298K DOE
Full benefits package to be discussed on a per person basis.
Redeployment is defined as the process of moving people to a different place or using them in a more effective way. We are a recruiting and executive search firm that uses our size and unique background to provide a personalized hiring experience to startups as they raise money, expand their business, and grow their team. With a focus in the biotech space, our expertise is getting to know and understand company culture, ensuring the RIGHT prospects are connected to the RIGHT companies
Thomas@Redeployment.us
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