Global Regulatory CMC Manager
American Cybersystems, Inc.

Innova Solutions is immediately hiring for an Global Regulatory CMC Manager

Tittle: Global Regulatory CMC Manager
Duration: 9 months Contract
Location: Lawrenceville ,NJ (onsite)
Pay Range*: $88.57 - $89.85 per hour.

As a(n)Global Regulatory CMC Manager you will:

Job Description:

• Participate in the development of the CMC regulatory strategy for biologics submissions. These submissions include health authority briefing packages, IND/CTA, BLA/NDA and MAA regulatory filings.
• Prepare and review CMC submission documents, registration dossiers, health authority briefing packages and responses to health authorities through collaborations with relevant line functions and with minimal supervision.
• Responsible for the global regulatory evaluation of CMC change controls with supervision.
• Responsible for the management of CMC activities related to developmental or commercial compounds, with supervision.
• Represent Regulatory CMC on cross-functional development/commercial teams and Regulatory Affairs teams.
• Facilitate document review meetings and discussions.
• Develop and maintain knowledge of regulatory environment, regulations and procedures.

The ideal candidate will have:

• BS/BA degree in Scientific Discipline
• 3 years in the pharmaceutical industry, preferably with 1 year CMC regulatory experience
• Experience with CMC regulatory documents (IND/CTAs, BLAs, MAAs, responses and variations)
• Knowledge of FDA, EMA and/or ICH guidelines and CMC regulations
• Experience in drug development processes and post-approval requirements
• Experience in developing CMC regulatory strategy
• Experience in project management
• Have a solution-oriented approach to problem solving
• Ability to plan/prioritize work of group members and guide/develop others.
• Ability to work on complex projects and within cross-functional teams with supervision
• Excellent communication skills, both written and oral

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!

Aritra Roy

4702230481

Aritra.Roy@innovasolutions.com

PAY RANGE AND BENEFITS:

Pay Range*: $88.57 - $89.85 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:

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

This job has expired.