R&D Regulatory Specialist (Remote)
American Cybersystems, Inc.

Job Info

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Innova Solutions has a client that is immediately hiring for an R&D Regulatory Specialist

Position type: Full time Contract
Duration: Remote
Location: 6 months

As a(n) R&D Regulatory Specialist you will:

Develops and implements worldwide regulatory programs for marketed products and/or those for development, and has interactions with regulatory authorities to expedite approvals.
Participate in the development of, and leads/executes regulatory strategy and tactical decisions from project inception to regulatory approval, including lifecycle management of existing products.
Serve as a regulatory representative on cross functional project teams, applying advanced knowledge of regulations and interpretation of technical guidelines to assure execution of regulatory strategies and requirements.

Job Duties:
• Develops and implements worldwide regulatory strategies for projects and issues affecting development of new products or medical devices or new indications for existing products
• Provides regulatory expertise to Research and Development to support the design and analyses of projects.
Interacts with cross-functional groups to ensure alignment of technical activities with regulatory strategies.
• Utilizes scientific training when interfacing with Management of technical areas and project teams to guide the scope of experimentation and the selection of data needed to support regulatory submissions.
• Interacts with regulatory authorities regarding programs and initiatives that significantly impact the business.
• Advises Management on regulatory aspects of product development and/or lifecycle management. Identifies risk areas and develops alternative courses of action including anticipation of regulators responses through scenario planning and development of contingency plans.
• Ensures that technical documentation for regulatory submissions meets the appropriate standards and content requirements including planning and implementation around emerging/changing regulatory requirements.
• Writes documents with complex scientific information for regulatory submissions.

Job Requirements:
• Bachelor's Degree in a related scientific discipline with at least 4+ years of experience in positions of increasing responsibility within Regulatory Affairs or related field within the Biologics, Biotech or Pharmaceutical industry.
• Knowledge and understanding of FDA and EU regulations for the biotechnology and pharmaceutical industry.
Understanding of global regulatory regulations.
• Excellent oral and written communication skills.
Critical thinking and problem-solving skills.
• Demonstrated project management skills.
• Ability to interact with regulatory officials.
• Ability to evaluate complex issues and meet deadlines to ensure compliance, as well as business timelines to accomplish company objectives.
• Ability to work within a global team framework and multi-cultural environment.
• Ability to write comprehensive scientific information for use in regulatory submissions to the FDA and EU.
• Ability to manage multiple complex projects and timelines in a matrix team environment.
• Demonstrated interpersonal skills including negotiation.
• Ability to execute regulatory strategies through to commercialization/life cycle.
Prior experience in bridging several scientific disciplines.
• Leadership skills within a matrix driven organization.

Notes:

• This role will be a remote position and the contract employee can work from home anywhere in the US.
• The role is part-time and about 20 hours per week.
• The team will need someone in this role who can be flexible with the days and times of work to meet the needs of the company and the regulatory agencies.
• The ideal candidate will have regulatory experience in a pharma setting with FDA and EU submissions.
• Candidate should have a good sense of regulatory strategy and working with Regulatory Operations for various types of submissions.
• Experience working with in a cross-functional team and cross-cultural team as well.
• This role requires a minimum of a Bachelor's degree.

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!
SWEEKRITI KESHARI
(+1) 213-929-5182
Sweekriti.Keshari@innovasolutions.com
skeshari@acsicorp.com

PAY RANGE AND BENEFITS:
Pay Range*: $40 - $45 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 centers 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:

• Named One of America's Best Employers for New Grads by Forbes (2024
• Named One of the Best Companies to Work For by U.S. News & World Report (Private Companies List, 2024-2025)
• One of the Largest IT Staffing Firms in the US - Ranked #3 by Staffing Industry Analysts (SIA, 2024)
• One of the Largest Staffing Firms in the US - Ranked #13 by Staffing Industry Analysts (SIA, 2024; includes Innova Solutions, Volt, & HireGenics)
• Named One of the Top Ten Private Companies in Atlanta by the Atlanta Business Chronicle (2023)
• One of the Largest Certified Minority Business Enterprises (MBEs) in the United States (NMSDC, 2024)
• AWS Advanced Tier Services Partner with 100+ certifications

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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