Manager, Regulatory Affairs

Company: Innova
Location: San Rafael
Posted on: February 3, 2025

Job Description:

Innova Solutions has a client that is immediately hiring for a Manager, Regulatory Affairs

Do you have the following skills, experience and drive to succeed in this role Find out below.

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

As a(n) Manager, Regulatory Affairs you will:

Description:
The world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases. We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children. These conditions are often inherited, difficult to diagnose, progressively debilitating, and have few, if any, treatment options. aims to improve life and health outcomes for people with rare diseases by advocating the use of innovative therapeutics, advancing the standard of care and providing personalized support and services globally.

Global Regulatory Affairs (GRA) is responsible for obtaining approval for new products and ensuring that approval is maintained throughout the product lifecycle. GRA serves as the interface between the regulatory authorities and the program teams aiming to ensure that the project plan correctly anticipates what the regulatory authority will require before approving the product. It is the responsibility of GRA to keep abreast of current legislation, policies, guidelines and other regulatory intelligence. The RA department plays an important role in giving advice to the program teams on how best to interpret the regulatory legislation and guidelines

The Manager supports Global Reg Teams in the development and execution of global nonclinical / clinical regulatory strategies through a program's lifecycle. [Open to position being Remote]
Responsibilities may vary depending upon product regulatory lifecycle and may include the leadership of selected activities which will be delegated by the Regulatory Nonclinical/ Clinical Lead and may include the following:
Development Stage Product
Support the development of the nonclinical / clinical regulatory strategy and plan.
Assist with selected planning, document development and meeting execution activities in preparation for HA meetings / interactions.
Participate in Study Execution Teams for assigned products and identify relevant regulatory considerations for discussion with RNC Lead.
Collaborate with CROs that are contracted to perform regulatory submissions/HA interactions for global clinical trials.
With oversight by RNC lead, develop and coordinate the core nonclinical / clinical content of regulatory submissions.
Responsible for ensuring high quality nonclin/clinical content that adheres to regulations and guidances.
Lead the maintenance of IND/CTAs throughout the life of the studies (e.g., annual reports)
Assist with the preparation of HA submission packages including but not limited to compiling relevant materials (Protocols, Annual Reports, Briefing Books, etc.) and completing regulatory documents/forms for internal review.
Collaborate with Reg PM to create and align submission timelines,
Collaborate with Reg Ops to provide final documents and QC published outputs for submissions to HA.
Oversee the collaboration of Nonclin/clin with Reg Ops to provide final documents and QC published outputs for submissions to HA.
Organize and maintain the administrative, nonclinical, and clinical portions of IND's, NDA's and BLA's.
Oversee the archiving of HA submissions and correspondence

Commercial Stage Product
Lead the development of updates to the clinical and nonclinical sections of the core dossier used for INTL marketing applications.
Provide support to RNC lead on development of nonclinical / clinical portions of required product lifecycle maintenance regulatory submissions, examples are: clinical or nonclinical supplements to approved US product dossiers and any required annual reports, license renewals, supplemental filings.
Coordinate necessary interactions with INTL in support of INTL MA filings. Example include: meetings to provide RNC guidance/input on agency interaction, submissions, RTQs.

General
Attend relevant functional area and project team meetings.
Review, understand and stay up to date on regulations, guidelines relevant to responsibilities
Review documents (SOPs, protocols and reports) related to Clinical or Nonclinical studies as necessary
Ensure that the PM timelines and tracker accurately reflect submission plans




Skills:
Decision Making and Problem Solving, including an understanding of decision-making models and methodology
Influence, Cross-Functional Collaboration and Organizational Awareness, including demonstrating professional maturity, including understanding own strengths and receptivity to feedback
Agility and Proactivity, including an ability to anticipate risks or issues to program or business and take the necessary steps to mitigate or address
Leadership, such as skill in clearly communicating objectives, goals, and expectations to others
Communication, including an ability to provide context and articulate key messages effectively and with appropriate level of detail
Strategic Thinking and Planning, such an ability to set short-term and longer-term goals for individual objectives and task completion
Regulatory Strategy, Frameworks and Processes: Demonstrates basic understanding of regulations, guidances and pathways including when and how to file routine submissions; asks appropriate question to clarify / validate understanding
Health Authority Engagement: Knows basics of how relevant health authorities function, their general structure and the key personnel
Scientific Writing for Regulatory Submissions: Demonstrates basic knowledge of content guidelines and structures (sections, etc.) for writing routine regulatory submissions (i.e., annual reports)
Drug Development and Study Design: Understands the objectives/purpose of each drug development phase and the related objectives and regulatory requirements, including as it relates to rare disease development
Scientific and Medical Knowledge: Understands the implications of competitive product developments on therapeutic area regulatory strategies / plans

Education:
Degree in health or life sciences, including chemistry, molecular biology, or similar. PhD preferred, Masters/Bachelors acceptable with relevant experience
4 + year experience with PhD; 6+ years with Master's or bachelor's degrees
Nonclinical / Clinical Regulatory Affairs 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!
SWEEKRITI KESHARI
(+1) 213-929-5182
Sweekriti.Keshari@innovasolutions.com
skeshari@acsicorp.com

PAY RANGE AND BENEFITS:
Pay Range*: $40 - $60 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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