Jobs

Regulatory Affairs Manager

What You Will Do:
We are currently searching for a Regulatory Affairs Manager to support the National Institutes of Health (NIH). This opportunity is a full-time position with MSC, and it is on-site in Bethesda, MD.

• Serve as a regulatory affairs management expert. Responsible for managing an Investigational New Drug (IND) application portfolio of products consisting of vaccines and monoclonal antibodies for compliance with the Food and Drug Administration (FDA) regulations for use of investigational products in humans.
• Serve as an expert on all regulatory matters concerning the development of vaccines and monoclonal antibodies. This involves strategy, implementation, review processes, submissions and compliance with the FDA, National Institutes of Health (NIH) and international regulatory authority regulations.
• Provide recommendations to the office Director on optimal strategies to advance candidate products to the clinic.
• Write and review documentation for compliance with FDA current Good Clinical Practice (cGCP), Good Laboratory Practice (GLP), and/or current Good Manufacturing Practice (cGMP). These documents include, but are not limited to, clinical study protocols, informed consent documents, to ensure test plans encompass all required test elements, data parameters, test objectives, chemistry manufacturing and control (CMC) documents, and nonclinical study report summaries.
• Responsible for the management and quality of the Investigational New Drug (IND) application and amendments throughout its lifecycle which includes writing, reviewing and/or editing the initial IND submission, IND amendments, Investigator Brochures and FDA annual reports.
• Responsible for pre-pre and pre-IND meetings and meeting packages, and responses to FDA queries.
• Develop standard operating procedures, evaluate emerging regulations and changing regulatory landscape for impacts, provide strategic advice, and communicate with stakeholders which may include recommending applicable education and training to personnel for assurance of regulatory compliance.
• Serve as liaison between the Office and other components involved in product development.
• Serve on product development teams as the regulatory expert.

What You Will Need:

• Minimum of a Master’s degree with at least four (4) years of experience in regulatory affairs related to the approval of vaccines and therapeutics for human use.
• Expert knowledge of the relationship of clinical research investigators, regulatory agencies like the FDA, and others in the complex network of oversight responsibilities for the conduct of safe and effective clinical research.
• Ability to analyze, explain, and apply the relevant regulatory provisions in a wide variety of settings and with diverse audiences in order to advance the research program.
• Ability to communicate both orally and in writing. Prepare and present highly complex material, often on conflicting issues, for a broad range of participants including senior level Department and agency officials, scientific community groups, and members of the public.
• The qualified individual must be able to make presentations to a variety of audiences and articulate the policies, initiatives, and programs relevant to the activities of the program. Audiences may include individuals from a diverse cultural and/or socioeconomic background.
• The work covers a diversity of duties requiring the synthesis of knowledge, skills, and experience from different fields such as FDA regulatory management, human subjects’ protection requirements, strategic planning, administration, policy analysis, oral and written communication, and project management.

What Would Be Nice To Have:

What We Offer:

Guidehouse offers a comprehensive, total rewards package that includes competitive compensation and a flexible benefits package that reflects our commitment to creating a diverse and supportive workplace.

Benefits include:

• Medical, Rx, Dental & Vision Insurance
• Personal and Family Sick Time & Company Paid Holidays
• Parental Leave
• 401(k) Retirement Plan
• Group Term Life and Travel Assistance
• Voluntary Life and AD&D Insurance
• Health Savings Account, Health Care & Dependent Care Flexible Spending Accounts
• Transit and Parking Commuter Benefits
• Short-Term & Long-Term Disability
• Tuition Reimbursement, Personal Development, Certifications & Learning Opportunities
• Employee Referral Program
• Corporate Sponsored Events & Community Outreach
• Care.com annual membership
• Employee Assistance Program
• Supplemental Benefits via Corestream (Critical Care, Hospital Indemnity, Accident Insurance, Legal Assistance and ID theft protection, etc.)
• Position may be eligible for a discretionary variable incentive bonus

About Guidehouse
Guidehouse is an Equal Employment Opportunity / Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, national origin, ancestry, citizenship status, military status, protected veteran status, religion, creed, physical or mental disability, medical condition, marital status, sex, sexual orientation, gender, gender identity or expression, age, genetic information, or any other basis protected by law, ordinance, or regulation.

Guidehouse will consider for employment qualified applicants with criminal histories in a manner consistent with the requirements of applicable law or ordinance including the Fair Chance Ordinance of Los Angeles and San Francisco.

If you have visited our website for information about employment opportunities, or to apply for a position, and you require an accommodation, please contact Guidehouse Recruiting at 1-571-633-1711 or via email at RecruitingAccommodation@guidehouse.com. All information you provide will be kept confidential and will be used only to the extent required to provide needed reasonable accommodation.

Guidehouse does not accept unsolicited resumes through or from search firms or staffing agencies. All unsolicited resumes will be considered the property of Guidehouse and Guidehouse will not be obligated to pay a placement fee.

Learn more here

Job posted: 2023-01-03