A career with MilliporeSigma is an ongoing journey of discovery: our 52,000 people are shaping how the world lives, works and plays through next generation advancements in healthcare, life science and performance materials. For more than 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others. MilliporeSigma is a business of Merck KGaA, Darmstadt, Germany.
We are currently seeking a Regulatory Expert with focused support for highly-potent active pharmaceutical ingredients (HPAPIs) and linker-payloads for anti-body drug conjugates, based in Madison WI, USA.
You will act as a Regulatory Expert to support regulatory submissions with a focus on HPAPIs, intermediates, and drug linkers in direct collaboration with customers.
You will support custom products within our contract development and manufacturing business, which includes customer-facing activities.
You work in a global regulatory team that shares systems and processes. You interact closely with the quality and operational units of the manufacturing site. You collaborate with internal experts within the technical and business areas and across the organization to gather data and support efforts.
You participate as the Regulatory Representative in supporting the customer’s product development process to develop and execute regulatory assessments and plans.
Your key responsibilities include:
- Responsibilities for registration dossiers such as DMFs, ASMFs, CEPs, BBMFs, and other master file documents (globally)
- Creation, technical writing, submission, responses to deficiencies
- Assessment of needs or changes to submitted dossiers through change control review
- Customer support:
- Works directly with customers in a consultative role to support customer’s regulatory drug substance sections for filings and submissions
- Prepare and review documents for submission to regulatory agencies in compliance with requirements
- Supports customers for MAA, NDA, BLA and IND supplements and activities
- Support provision of responses to customer regulatory inquiries
- Partner with customers to ensure timely written submissions for their filings
- Create policies and operating procedures to strengthen regulatory compliance
- Provide regulatory guidance to site operations, process development and quality groups upon request
- Support and utilize common regulatory organization tools such as tracking databases for planning, scheduling, submissions, and action dates, and overall project management
- Functions that fall within the RIMS (Regulatory Information Management System) - Review and approval of the RIMS entries
- Authority notifications, registrations, and licenses for registration purposes of pharmaceutical materials (when applicable)
- Regulatory Surveillance
- Regulatory deviation and change control activities
Who you are:
- Bachelor or Master level of education in pharmacy or life science with a strong emphasis in chemistry or biology. Masters in regulatory compliance also considered.
- Minimum of 10 years of relevant industry experience and/or regulatory affairs related to active ingredients, excipients, or other pharmaceutical substances
- Knowledgeable regarding US and EU drug regulations, specifically for submissions in CTD and eCTD format for drug substance/APIs.
- Knowledge of regulatory filings in other emerging regions is ideal.
- Experience with drug product technical writings, filings, and submissions
- Filings of biologics
- In-depth knowledge about requirements for filing, registration, and notification for drug substances is expected and drug product
- Experience dealing directly with customers
- Experience in consulting role
- Understands the concepts of regulatory surveillance
- Well-versed in regulatory trends for pharmaceutical materials
- Skilled expert in customer’s regulatory requirements for finished pharmaceuticals
- Experience in e-submission tools
- Proficient in MS Office Software (Word, Excel, PowerPoint) and ERP Systems such as Oracle or SAP.
- Track wise experience
- Demonstrate good communication & project management skills.
- Work successfully within a multidisciplinary international team.
What we offer: With us, there are always opportunities to break new ground. We empower you to fulfil your ambitions, and our diverse businesses offer various career moves to seek new horizons. We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life. Join us and bring your curiosity to life!
Curious? Apply and find more information at https://jobs.vibrantm.com
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.