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Regulatory Affairs Program Manager Jobs in Indiana

Magna

Program Manager

Muncie, IN · On-site

Must possess a combined 5 years of program management experience along with a verifiable record of ... Maintains working knowledge of safety policies and regulations to ensure duties of self and others ...

Magna

Program Manager

Muncie, IN · On-site

Must possess a combined 5 years of program management experience along with a verifiable record of ... Maintains working knowledge of safety policies and regulations to ensure duties of self and others ...

COMLUX AMERICA LLC

Program Manager

Indianapolis, IN · On-site

... for planning,managing, and administering VIP interior cabin completion programs fortransport ... Regulatory AuthoritySupplemental Type Certificate (STC) projects. This role serves as the ...

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Regulatory Affairs Program Manager information

What does a regulatory affairs program manager do?

A Regulatory Affairs Program Manager oversees and coordinates regulatory activities to ensure that a company's products comply with all applicable laws and regulations. They manage submission processes for product approvals, communicate with regulatory agencies, and develop strategies to maintain compliance throughout the product lifecycle. Additionally, they collaborate with cross-functional teams such as research and development, quality assurance, and manufacturing to align regulatory requirements with business objectives. Their role is crucial in minimizing regulatory risks and accelerating the time to market for new products.

What are some typical challenges faced by regulatory affairs program managers when coordinating cross-functional teams?

Regulatory Affairs Program Managers often encounter challenges in aligning the objectives and timelines of different departments such as clinical, quality, and R&D. Balancing varying priorities, managing tight submission deadlines, and ensuring consistent communication between teams are common hurdles. Successful Program Managers proactively foster collaboration, clarify regulatory requirements, and facilitate regular updates to keep projects on track. Being able to anticipate and resolve conflicts, while adapting to evolving regulations, is key to driving effective program execution.

What are the key skills and qualifications needed to thrive as a regulatory affairs program manager, and why are they important?

To thrive as a Regulatory Affairs Program Manager, you need expertise in regulatory guidelines, project management, and a relevant science or healthcare degree. Familiarity with regulatory submission systems, document management tools, and certifications such as RAC (Regulatory Affairs Certification) are highly beneficial. Strong attention to detail, strategic communication, and collaborative problem-solving are crucial soft skills in this role. These competencies ensure efficient navigation of complex regulatory requirements, timely submissions, and successful product approvals.

What is the difference between Regulatory Affairs Program Manager vs Regulatory Affairs Specialist?

AspectRegulatory Affairs Program ManagerRegulatory Affairs Specialist
CredentialsTypically requires a bachelor’s degree in life sciences, regulatory affairs certification (RAC) preferredUsually holds a bachelor’s degree in life sciences or related field; RAC certification is a plus
Work EnvironmentManages multiple projects, oversees teams, and collaborates with cross-functional departmentsFocuses on preparing and submitting regulatory documents, supporting project teams
Employer & Industry UsageUsed in pharmaceutical, biotech, and medical device companies for leadership rolesCommonly employed in similar industries for entry- to mid-level regulatory roles

The Regulatory Affairs Program Manager oversees regulatory strategies and manages teams, while the Regulatory Affairs Specialist handles document preparation and submission. Both roles require relevant credentials and are vital in ensuring compliance within regulated industries.

Is regulatory affairs high paying?

Regulatory Affairs Program Managers typically earn competitive salaries that reflect their specialized knowledge of regulations, compliance, and industry standards. Salaries can vary based on experience, location, and the complexity of the regulatory environment, with many roles offering above-average compensation in the healthcare, pharmaceutical, and biotech sectors.

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Regulatory Affairs Program Manager jobs near you

Program Manager

Magna

Muncie, IN • On-site

Full-time

Re-posted yesterday

Job description

Job descriptions may display in multiple languagesbased on your language selection.

What we offer:
At Magna, you can expect an engaging and dynamic environment where you can help to develop industry-leading automotive technologies. We invest in our employees, providing them with the support and resources they need to succeed. As a member of our global team, you can expect exciting, varied responsibilities as well as a wide range of development prospects. Because we believe that your career path should be as unique as you are.
Group Summary:
Transforming mobility. Making automotive technology that is smarter, cleaner, safer and lighter. That's what we're passionate about at Magna Powertrain, and we do it by creating world-class powertrain systems. We are a premier supplier for the global automotive industry with full capabilities in design, development, testing and manufacturing of complex powertrain systems. Our name stands for quality, environmental consciousness, and safety. Innovation is what drives us and we drive innovation. Dream big and create the future of mobility at Magna Powertrain.

Job Responsibilities:

Minimum Qualifications

  • Must possess a combined 5 years of program management experience along with a verifiable record of results in both disciplines within the automotive industry.
  • Bachelor's degree Required or equivalent (6 additional years of related technical experience in addition to experience referenced above). Technical / Engineering Degree is highly preferred.
  • Strong technical background that may include knowledge of powertrain systems & components (including 4WD/AWD, fluid pressure & controls, stampings & castings) and a good understanding of cross-functional responsibilities.
  • Must possess moderately advanced usage of Microsoft Office (Word, Excel, & PowerPoint); must be/become proficient in company & customer systems.
  • Previous experience in a plant operations role or environment is preferred.
  • Strong Financial acumen, considered an asset.

Key Responsibilities

  • Primary point of communication interface to the customer for the respective program(s).
  • Possesses the interpersonal skills to build relationships with key customer contacts responsible for the decision-making process. Actively listens, probes, and identifies concerns. Understands customer's business and speaks their language. Develops credibility, loyalty, trust, and commitment.
  • Responsible for leading the preparation and business case review of quotations for customers. Responsible for ensuring quotes target profitable and/or strategic business opportunities and performing contract reviews when awarded.
  • Cohesively aligns with Global Product Managers, Product Engineering, and Sales by providing customer feedback on products and features as well as competitive information within their respective product group.
  • Owns program management through complete product life cycle from concept, quoting, program award, product development, supplier selection, launch, post-production performance, & lessons learned utilizing the Magna Global Program Management System (GPMS):
  • Preparation and communication of program status meetings to management steering committee and escalation of critical issues.
  • Coordinating / monitoring project documentation, timelines, technical performance, budget, production, quality deliverables, and corrective action initiatives.
  • Full program management ownership of program-related functional activities: quoting, purchasing, product engineering, quality, manufacturing / launch management, & finance/budget.
  • Manage Series Production Phase including claims management, change management & continuous improvement, VA/VE activities, and execution of ongoing price negotiations / adjustments.
  • Supports and adheres to policies, procedures, and operational guidelines related to established quality management system (IATF 16949).
  • Maintains working knowledge of safety policies and regulations to ensure duties of self and others are performed in a safe manner.
  • Additional duties and responsibilities as assigned.
  • Must understand the financial aspects of the business
Awareness, Unity, Empowerment:

At Magna, we believe that a diverse workforce is critical to our success. That's why we are proud to be an equal opportunity employer. We hire on the basis of experience and qualifications, and in consideration of job requirements, regardless of, in particular, color, ancestry, religion, gender, origin, sexual orientation, age, citizenship, marital status, disability or gender identity. Magna takes the privacy of your personal information seriously. We discourage you from sending applications via email or traditional mail to comply with GDPR requirements and your local Data Privacy Law.

Worker Type:

Regular / Permanent

Group:

Magna Powertrain

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