Senior Regulatory Expert

Posted 26 Jan 2024

Indianapolis, Indiana - United States

Req Id 271404

 

Work Your Magic with us!

Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.

This role does not offer sponsorship for work authorization. External applicants must be eligible to work in the US. 


Your Role:

We are currently seeking a Regulatory Expert CDMO - based in Indianapolis, IN, USA.

As an Expert in Regulatory Management, you work on strategic regulatory activities as Contract and Development Manufacturing Organization (CDMO).  You assume responsibility for regulatory tasks related to fill and finish processes for sterile drug products, liposomal and lipid-nano particle formulations, produced in contract and for in-line products.  This includes encapsulation of chemical and biologic derived active substances.  You will work closely connected to site quality and a global regulatory team that shares systems and processes. 

 

You collaborate with internal experts within the quality, technical and business areas across the organization to gather data and support efforts.  You support the manufacturing site in Indianapolis and distribution activities to comply with regional regulatory requirements.  You interpret and transfer country regulatory requirements for providing prospective advice and for identifying potential pharmaceutical issues and risks.  You will support our CDMO customers in their regulatory activities by leading responses from authorities through our clients and/or by creating regulatory submission documents for drug products developed and manufactured in contract for our clients.

 

You will work with the Global Regulatory team to:

  • Discuss and develop a regulatory strategy, develop regulatory assessments,
  • Ensure execution of regulatory objectives in a timely fashion
  • Create policies and operating procedures to strengthen Regulatory compliance against FDA and EMA standards.

You will work with site colleagues and business to ensure specific processes and strategy goals are aligned such as:

  • Manage relevant site registrations and licenses for registration purposes of pharmaceutical products, including state wholesale licenses,
  • Manage and support registration of the site or products in relevant countries, with respect to products manufactured in contract for our clients,
  • Act as regulatory contact for the site, create and manage site relevant information as authority submission, e.g., Type V DMF submission, 
  • Support and manage authority and client audit responses and reports relate to regulatory filing, to ensure their timely written submissions,
  • Prepare and review documents for submission to regulatory agencies in compliance with requirements.
  • Create and maintain responses to deficiencies and assess changes impacting submitted CMC documents through change control process,
  • Participate in site change control process to provide regulatory assessment and processes for CMC Dossier approvals, 
  • Create regulatory chemistry, manufacturing, and control (CMC) documents for products developed and manufactured in contract for our clients, including biological and biotechnological derived products, 
  • Utilize our electronic Regulatory Data Management System (eRDMS) for authoring and maintenance of CMC documents, and for planning, scheduling, submissions, and tracking action dates.
  • Ensure that relevant changes to product registrations and listings are properly notified to the relevant authorities. 

 

You provide regulatory support to our customers:

  • Work in a consultative role to support customer’s regulatory drug product sections for filings and submissions.
  • Prepare country-specific health authority responses and impact of overall strategy for dossiers.
  • Support provisions of responses to customer regulatory inquiries.

 

Who you are:  

Minimum Qualifications:

  • Bachelor or Master level of education in pharmacy or life sciences with a strong emphasis in chemistry or biology.
  • Minimum of 5 years of relevant industry experience and/or regulatory affairs related to sterile manufacturing process for drug product, biopharmaceutical active ingredients, pharmaceutical substances, and process materials (with focus on biologics).  Certification for regulatory professionals in the healthcare sector, e.g, RAPS, is a plus.

Preferred Qualifications:

  • Knowledgeable of US FDA and EU drug regulations, specifically for submissions in CTD format for drug products, including IND submissions.  Knowledge of regulatory landscape of other important regions, e.g., in Asia.
  • In depth understanding of validation process associated with sterility assurance, such as but not limited to, media simulations, cleanroom qualification and classification, autoclaving, isolator qualification and fumigation is a plus. 
  • Strong communication skills, strong technical writing and interpretation skills related to investigations and Regulatory Filings
  • Experience in e-submission tools is welcome.
  • Proficient in MS Office Software (Word, Excel, PowerPoint, Project) and ERP Systems such as Oracle or SAP. Demonstrate good communication & project management skills. Work successfully within a multidisciplinary international team.


What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We celebrate all dimensions of diversity and believe that it drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!
 
Apply now and become a part of our diverse team!

 

If you would like to know more about what diversity, equity, and inclusion means to us, please visit https://www.emdgroup.com/en/company/press-positions.html


US Equal Employment Opportunities

The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law.  This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.

We are committed to an equitable hiring process for candidates from a diverse range of backgrounds. As part of this commitment, applicants with disabilities may be entitled to reasonable accommodations. Please contact USLeavesandAccommodations@milliporesigma.com, if a reasonable accommodation is needed or if you otherwise need assistance to participate in the hiring process.


North America Disclosure

If you are a resident of California, Colorado, New York, or Washington, you are eligible to receive additional information about the compensation and benefits, which we will provide upon request. You may contact 855 444 5678 from 8:00am to 5:30pm ET Monday through Friday, for assistance.


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