Jobs
>
San Diego

    Vice President, Regulatory Affairs - San Diego, United States - Device Search Group

    Device Search Group
    Device Search Group San Diego, United States

    2 weeks ago

    Default job background
    Pharmaceutical / Bio-tech
    Description

    We are seeking an experienced Senior Director or Vice President of Regulatory Affairs (DOE).

    As the head of Regulatory Affairs you will be responsible for leading and managing all aspects of Clinical and CMC Regulatory Affairs. The ideal candidate will have a strong background in cell therapy with experience in early development regulatory affairs (pre-IND and IND submissions). Experience with BLA submissions is a plus. This role offers a flexible and diverse work environment and an excellent benefit package.

    Key Responsibilities:

    Develop and implement regulatory strategies to support the early development of cell therapy products

    Lead interactions with regulatory agencies to ensure compliance with all relevant regulations and guidelines for pre-IND and IND submissions

    Provide guidance and support to cross-functional teams on regulatory requirements throughout the early development process

    Oversee the preparation and submission of regulatory documents, including INDs and other regulatory filings

    Stay current on regulatory trends and developments in early development of cell therapy products to ensure compliance and strategic advantage

    Qualifications:

    Bachelor's degree in a scientific or related field required; advanced degree preferred

    Minimum of 10 years of experience in regulatory affairs within the biopharmaceutical industry with at least 5 years in cell therapy

    -3 years of previous leadership experience preferred

    Demonstrated experience in early development regulatory affairs, with specific experience in pre-IND and IND submissions

    Experience with BLA submissions is a plus

    Strong understanding of FDA and international regulatory requirements for early development of cell therapy products

    Excellent communication and leadership skills

    Ability to work effectively in a fast-paced, dynamic environment

    This is an exciting opportunity to join a growing company at the forefront of cell therapy development. If you have the experience and qualifications required for this role, we encourage you to apply today.

  • Genalyte

    Regulatory Affairs Specialist

    3 weeks ago

    Genalyte San Diego, United States

    Here at Genalyte, you will find yourself working with talented individuals inspired by our vision, eager to make an impact on the patient experience, and who share a common goal of getting our technology into every physician's office. We have a great opportunity for a Regulatory ...

  • Adecco Permanent Recruitment

    Regulatory Affairs Specialist

    2 weeks ago

    Adecco Permanent Recruitment San Diego, United States

    Regulatory Affairs Specialist · Salary Range: $90,000.00 To 110,000.00 Annually · About the Opportunity: · The Regulatory Affairs Specialist will work in conjunction with the Quality and Regulatory team to create, maintain and approve regulatory technical documentation, licensin ...

  • Cypress HCM

    Regulatory Affairs Specialist

    3 weeks ago

    Cypress HCM San Diego, United States

    Regulatory Affairs Specialist · The Regulatory Affairs Specialist IV will coordinate the accumulation of technical information and prepare submissions for in vitro diagnostic and medical device licenses to various governmental regulatory agencies. They will also coordinate clini ...

  • Adecco Permanent Recruitment

    Regulatory Affairs Specialist

    2 weeks ago

    Adecco Permanent Recruitment San Diego, United States

    Regulatory Affairs Specialist · Salary Range: $90,000.00 To 110,000.00 Annually · The full job description covers all associated skills, previous experience, and any qualifications that applicants are expected to have. · About the Opportunity: · The Regulatory Affairs Special ...

  • Kaye/Bassman International

    Head of Regulatory Affairs

    13 hours ago

    Kaye/Bassman International San Diego, United States

    Position Title: Head of Regulatory Affairs · Location: Southern California · Company Overview: We are partnered with a cutting-edge pre-IPO cell therapy company dedicated to transforming the lives of patients with cancer and autoimmune diseases. There innovative pipeline harnesse ...

  • Insight Global

    Principal Regulatory Affairs

    3 weeks ago

    Insight Global San Diego, United States

    An employer is looking for a Principal Regulatory Affairs team member. This member would be responsible for 510K submissions and be responsible for developing regulatory strategies, preparing U. S. and major market submissions and obtaining approval to introduce new spinal implan ...

  • Genalyte

    Regulatory Affairs Specialist

    3 days ago

    Genalyte San Diego, United States

    Here at Genalyte, you will find yourself working with talented individuals inspired by our vision, eager to make an impact on the patient experience, and who share a common goal of getting our technology into every physician's office. We have a great opportunity for a Regulatory ...

  • Genalyte

    Regulatory Affairs Specialist

    3 weeks ago

    Genalyte San Diego, United States

    Here at Genalyte, you will find yourself working with talented individuals inspired by our vision, eager to make an impact on the patient experience, and who share a common goal of getting our technology into every physicians office. We have a great opportunity for a Regulatory A ...

  • East Ridge

    Regulatory Affairs Specialist

    2 weeks ago

    East Ridge San Diego, United States

    Job Description · Job Description · Eastridge Workforce Solutions is hiring a · Regulatory Affairs Specialist · for a company that offers cloud-based laboratory testing of blood tests through a central lab before releasing them to physicians for review and discussion with the ...

  • Argen

    Regulatory Affairs Specialist

    2 weeks ago

    Argen San Diego, United States

    Job Description · Job Description · Regulatory Affairs Specialist · Monday – Friday, 8:30 am – 5:00 pm · About Us · At Argen, we're in the business of creating healthy, confident smiles one case at a time. Argen is a global leader in dental manufacturing with headquarters in Sa ...

  • Argen

    Regulatory Affairs Specialist

    3 weeks ago

    Argen San Diego, United States

    Regulatory Affairs Specialist · Monday - Friday, 8:30 am - 5:00 pm · About Us · At Argen, we're in the business of creating healthy, confident smiles one case at a time. Argen is a global leader in dental manufacturing with headquarters in San Diego, CA, subsidiaries in Canada, G ...

  • Aequor Technologies

    Regulatory Affairs Specialist

    1 week ago

    Aequor Technologies San Diego, United States

    US Regulatory Affairs Lead · SCOPE OF RESPONSIBILITIES: · " He/She will be responsible for representing regulatory function to approve promotional material · " He/She will be at ease working in a matrix environment and be able to navigate ambiguity to drive decision making workin ...

  • Adecco Permanent Recruitment

    Regulatory Affairs Specialist

    3 weeks ago

    Adecco Permanent Recruitment San Diego, United States

    Regulatory Affairs Specialist · Salary Range: $90,000.00 To 110,000.00 Annually · About the Opportunity: · The Regulatory Affairs Specialist will work in conjunction with the Quality and Regulatory team to create, maintain and approve regulatory technical documentation, licens ...

  • Genalyte

    Regulatory Affairs Specialist

    5 days ago

    Genalyte San Diego, United States

    Job Description · Job Description · Here at Genalyte, you will find yourself working with talented individuals inspired by our vision, eager to make an impact on the patient experience, and who share a common goal of getting our technology into every physician's office. We have ...

  • Genalyte

    Regulatory Affairs Specialist

    2 weeks ago

    Genalyte San Diego, United States

    Here at Genalyte, you will find yourself working with talented individuals inspired by our vision, eager to make an impact on the patient experience, and who share a common goal of getting our technology into every physician's office. We have a great opportunity for a Regulatory ...

  • Eastridge InfoTech

    Regulatory Affairs Specialist

    5 days ago

    Eastridge InfoTech San Diego, United States

    Eastridge Workforce Solutions is hiring a · Regulatory Affairs Specialist · for a c ompany that offers cloud-based laboratory testing of blood tests through a central lab before releasing them to physicians for review and discussion with their patients, as well as providing con ...

  • Aequor Technologies

    Regulatory Affairs Specialist

    1 week ago

    Aequor Technologies San Diego, United States

    US Regulatory Affairs Lead SCOPE OF RESPONSIBILITIES:' He/She will be responsible for representing regulatory function to approve promotional material' He/She will be at ease working in a matrix environment and be able to navigate ambiguity to drive decision making working across ...

  • East Ridge

    Regulatory Affairs Specialist

    1 week ago

    East Ridge San Diego, United States

    Job Description Job Description Eastridge Workforce Solutions is hiring a Regulatory Affairs Specialist for a company that offers cloud-based laboratory testing of blood tests through a central lab before releasing them to physicians for review and discussion with their patients, ...

  • Aequor Technologies

    Regulatory Affairs Specialist

    2 weeks ago

    Aequor Technologies San Diego, United States

    US Regulatory Affairs Lead · SCOPE OF RESPONSIBILITIES: · " He/She will be responsible for representing regulatory function to approve promotional material · " He/She will be at ease working in a matrix environment and be able to navigate ambiguity to drive decision making wor ...

  • Eastridge InfoTech

    Regulatory Affairs Specialist

    3 weeks ago

    Eastridge InfoTech San Diego, United States

    Eastridge Workforce Solutions is hiring a Regulatory Affairs Specialist for a c ompany that offers cloud-based laboratory testing of blood tests through a central lab before releasing them to physicians for review and discussion with their patients, as well as providing consultin ...