Associate Director, Regulatory Affairs
American Cybersystems, Inc.

Job Info

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Innova Solutions is immediately hiring for an Associate Director, Regulatory Affairs

Position type: Full time Contract
Duration: 6 months
Location: San Rafael, CA

As a Associate Director, Regulatory Affairs , you will:

Job Description:

Regulatory Strategy Development
Lead the development, integration, execution and maintenance of the global nonclinical and clinical regulatory strategy for the Global Regulatory Plan (GRP) throughout the product lifecycle.
Ensure strategic alignment with the Clinical Development Plan (CDP) and nonclinical development plan with input from clinical and nonclinical Subject Matter Experts (SMEs), respectively, and regional regulatory leads.
Provide strategic insight to the GRT regarding product development and serve as Regulatory contributor to partner teams (eg, study execution teams, clinical development team etc.) as appropriate.
In collaboration with regional regulatory representatives, ensure that feedback from global Health Authorities is incorporated into the global nonclinical and clinical development strategy.
Incorporate RA INTL guidance on development programs (i.e., INTL requirements or policies that may impact clinical development and commercialization).
Develop global pediatric strategy; collaborate with regional leads on the content for regional pediatric plans (e.g., PIP); ensure global pediatric strategy is reflected in the Global Regulatory Plan; ensure any changes to CDP or Nonclinical development plans are assessed by regional leads for impact to pediatric plan agreements with Health Authorities.
Lead/support strategy for life-cycle expansion opportunities.
Clinical and Nonclinical Development Plan Advancement
Act as a key contributor to the Clinical and Nonclinical Development Plans and ensure that they incorporate consideration of current global health authority precedents and regulatory guidance.
Provide both proactive and reactive strategic input and regulatory expertise in the design and conduct of clinical and nonclinical studies.
Contribute critically to the scientific interpretation and integration of clinical and nonclinical study results.
Review and provide comments on all company- sponsored abstracts, manuscripts and publications of original research and press-releases, as requested.
In collaboration with Regulatory Affairs functional management, coordinate the provision of resources from the various Regulatory functions in support of clinical studies.
Skills:
Health Authority Meetings
Lead planning and preparation of the clinical and nonclinical strategy and content for global HA meetings, working closely with SMEs and regional regulatory leads.
Deliverables include core content for the briefing book, presentation, and the Q&A strategy map.
Lead clinical and nonclinical FDA interactions in alignment with corporate and/or program goals.
Serve as the point of contact for FDA regarding nonclinical/clinical communications.
Ensure that global HA feedback is incorporated into the clinical and nonclinical aspects of the development programs.
Regulatory Submissions and related activities
Broadly, ensure that the clinical and nonclinical content is adequately presented in submissions leading to successful clinical trial applications and product approvals.
Oversee any CRO/vendors that are contracted to perform any of the regulatory activities related regulatory submissions and HA interactions IND/CTAs:
Lead planning and preparation of core clinical and nonclinical content for global clinical trial applications, collaborating with SMEs and regional regulatory representatives.
Lead collaboration with CROs to support global clinical trials in line with corporate goals.
Coordinate maintenance of IND/CTAs globally through clinical trial completion.
Directly responsible for nonclinical/clinical aspects of US FDA IND submissions.
Partner with regional regulatory representatives to confirm CTA requirements as needed (i.e., confirm information provided by CROs)
Maintain IND/CTAs through end of clinical studies.
Facilitate US clinical trial results postings on CT.gov.
Marketing Applications (MAs):
Lead the creation of the clinical and nonclinical content of core CTD / global dossier for use in global marketing applications, collaborating with SMEs and regional regulatory representatives.
Serve as RNC lead on MA Filing Team to support global MA preparation, submission, review through approvals.
Directly responsible for nonclinical/clinical aspects of US marketing applications, maintaining US license and ensuring fulfillment of any PMRs/PMCs
Education:
Degree in health or life sciences, including chemistry, molecular biology, or similar. PhD preferred; Masters/bachelor's acceptable with relevant experience
6 + year experience with PhD; 8+ years with master's or bachelor's degrees
Nonclinical / Clinical Regulatory Affairs experience preferred.
2 or more years of line management experience preferred.
Qualified candidates should APPLY NOW for immediate consideration! Please hit APPLY to provide the required information, and we will be back in touch as soon as possible.

We are currently interviewing to fill this and other similar positions. If this role is not a fit for you, we do offer a referral bonus program for referrals that we successfully place with our clients, subject to program guidelines. ASK ME HOW.

Thank you!

Namrata Gautam
Senior Associate Recruitment
PHONE: (+1) 314-523-1818
EMAIL: Namrata.Gautam@innovasolutions.com

PAY RANGE AND BENEFITS:
Pay Range*: $80- $86 per hour
*Pay range offered to a successful candidate will be based on several factors, including the candidate's education, work experience, work location, specific job duties, certifications, etc.

Benefits: Innova Solutions offers benefits( based on eligibility) that include the following: Medical & pharmacy coverage, Dental/vision insurance, 401(k), Health saving account (HSA) and Flexible spending account (FSA), Life Insurance, Pet Insurance, Short term and Long term Disability, Accident & Critical illness coverage, Pre-paid legal & ID theft protection, Sick time, and other types of paid leaves (as required by law), Employee Assistance Program (EAP).

ABOUT INNOVA SOLUTIONS: Founded in 1998 and headquartered in Atlanta, Georgia, Innova Solutions employs approximately 50,000 professionals worldwide and reports an annual revenue approaching $3 Billion. Through our global delivery centres across North America, Asia, and Europe, we deliver strategic technology and business transformation solutions to our clients, enabling them to operate as leaders within their fields.

Recent Recognitions:

• One of Largest IT Consulting Staffing firms in the USA - Recognized as #4 by Staffing Industry Analysts (SIA 2022)
• ClearlyRated® Client Diamond Award Winner (2020)
• One of the Largest Certified MBE Companies in the NMSDC Network (2022)
• Advanced Tier Services partner with AWS and Gold with MS

Website: https://www.innovasolutions.com/

Innova Solutions is an Equal Opportunity Employer and prohibits any kind of unlawful discrimination and harassment. Innova Solutions is committed to the principle of equal employment opportunity for all employees and to providing employees with a work environment free of discrimination and harassment on the basis of race, color, religion or belief, national origin, citizenship, social or ethnic origin, sex, age, physical or mental disability, veteran status, marital status, domestic partner status, sexual orientation, or any other status protected by the statutes, rules, and regulations in the locations where it operates. If you are an individual with a disability and need a reasonable accommodation to assist with your job search or application for employment, please contact us at hr@innovasolutions.com or (770) 493-5588. Please indicate the specifics of the assistance needed. Innova Solutions encourages all interested and qualified candidates to apply for employment opportunities. Innova Solutions (HireGenics/Volt) does not discriminate against applicants based on citizenship status, immigration status, or national origin, in accordance with 8 U.S.C. § 1324b. The company will consider for employment qualified applicants with arrest and conviction records in a manner that complies with the San Francisco Fair Chance Ordinance, the Los Angeles Fair Chance Initiative for Hiring Ordinance, and other applicable laws.

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