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Regulatory Affairs Specialist I
Posting Locations Germantown, WI
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Think Different.  Do Different.  Be Different.

Alcami is a world-class contract development and manufacturing organization (CDMO).  We are a team of dynamic individuals committed to developing life-saving drugs around the world.  A mindset of innovation, accountability and customer focus inspires us to be the most efficient, safe and reliable choice for our customers and the patients they serve.  In return, we offer challenging careers, accelerated professional growth and the opportunity to be part of something different.

Position Summary

The Regulatory Affairs Specialist is accountable for driving results in a fast-paced environment by performing activities to ensure that regulatory submissions support active pharmaceutical ingredient (API) business needs and that the business remains compliant with regulatory filings. Activities include preparation and submission of regulatory filings, written and verbal communication with regulatory agencies and clients, and providing regulatory affairs information and counsel to other site functions. The position requires superior leadership behaviors of the Alcami core competencies and non-negotiables, as well as expertise in functional competencies included in this position profile.

Essential Functions

  • Remain informed about regulations and regulatory trends concerning US FDA and other countries’ regulatory agencies.
  • Coordinate efforts associated with the preparation of regulatory documents or submissions such as DMFs, DMF amendments and DMF annual reports
  • May coordinate efforts associated with preparation of Annual Product Reviews
  • Determine the nature of regulatory filings required for proposed changes.
  • Submit, or facilitate submission of, regulatory filings.
  • Prepare or direct the preparation of additional information or responses as requested by regulatory agencies.
  • Coordinate company regulatory affairs activities with those of clients and respond to client requests for information.
  • Serve as RA subject matter expert for client and regulatory audits.
  • Prepare, or coordinate preparation of, annual product quality reviews.
  • Provide RA review of SOPs, change requests, and investigations.
  • Ensures timely completion and compliance with cGMP and all other relevant company training requirements.

Education and Experience

  • Bachelor’s or Master’s degree in science or engineering
  • Minimum 1 year experience in pharmaceutical regulatory affairs, API RA experience preferred.

Alcami Non-Negotiables

  • Consistently demonstrates honesty and integrity through personal example.
  • Follows all safety policies and leads by example a safety first culture.
  • Produces high quality work product with a focus on first time right.
  • Complies with the company code of conduct and policies and regulatory standards.

Alcami Core Leadership Competencies

  • Thinks strategically. Quickly identifies and acts on opportunities. Considers the downstream impact. Seeks to understand the why. Focuses on work that matters.
  • Develops organization and others. Takes ownership to develop self and others. Seeks out new opportunities and experiences for continuous learning.
  • Acts decisively. Makes and acts on decisions quickly. Makes decisions with the customer and their patients in mind. Meets commitments with a sense of urgency. Seeks ways to be more efficient.
  • Drives performance. Holds self and others accountable. Delivers results first time right. Never settles for status quo. Willing to have tough conversations. Asks for feedback and takes action to improve.
  • Passion for customers. Listens to understand. Asks the right questions. Gets to the heart of the matter and uses that insight to provide value.
  • Works collaboratively. Seeks out the experience of others with the aim for better results. Open minded regardless where ideas originate. Flexible and easy to work with.

Functional Competencies

  • Knowledge of RA principles and regulations and ability to apply them to a variety of situations.
  • Superior written and oral communication skills, including technical writing and ability to review complex documents and data sets for accuracy
  • Ability to interact well with clients, regulatory agents, and employees at all levels.
  • Working knowledge of pharmaceutical cGMP
  • Proficiency with Microsoft Office (Word, Excel, PowerPoint)

Travel Requirements

  • Up to 10% travel may be required.  

What We Offer You:

  • Competitive salary with career advancement opportunities
  • Profit sharing bonus plan
  • Medical, dental and vision coverage from day one
  • 401(k) with company match
  • Company paid vacation, holiday and sick-leave
  • Voluntary benefits including short & long term disability, life, accident, critical illness insurances

Diversity and Inclusion:

Alcami values diversity and we are committed to creating an inclusive environment for all employees.   All employment decisions are based on business needs, job requirements and individual qualifications, without regard to race, color, religion, sex, pregnancy, age, national origin, physical or mental disability, past or present military service, marital status, gender identification or expression, medical condition (including genetic characteristics) or any other protected characteristic as established by law.

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