1+ months

Quality Assurance Regulatory Manager

Kelly Services
Indianapolis, IN 46202
**Regulatory** **Manager**

**Job Description:**

As an Expert in Regulatory Management, you create regulatory submission documents for drug products developed and manufactured in contract for our clients. 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 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 regulatory requirements and good regulatory practices. 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.

**You will work with the Global Regulatory team to:**

Discuss and develop a regulatory strategy

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,

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.

Support and manage Regulatory and client audit responses and reports relate to regulatory filing, to ensure their timely written submissions.

Create, maintain, responses to deficiencies and assess changes impacting submitted CMC documents through change control process.

Prepare country-specific health authority responses and impact of overall strategy for dossiers.

Participate in Change Control procedures according to the current pharmaceutical requirements and systems and processes for CMC Dossier approvals.

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 customers regulatory drug product sections for filings and submissions

Prepare and review documents for submission to regulatory agencies in compliance with requirements.

Support provisions of responses to customer regulatory inquiries.

**Who you are:**

Bachelor or Master level of education in pharmacy or life sciences with a strong emphasis in chemistry or biology.

Experience in quality requirements for sterile manufacturing processes for drug products.,

Minimum of 5 years of relevant industry experience and/or regulatory affairs related to biopharmaceutical active ingredients, pharmaceutical substances and process materials (with focus on biologics).

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.

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 offer a modern and international working environment to

unleash your innovative potential in diverse teams, and take responsibility for our employees, products, the environment and society.


**You should know:** Your safety matters! Vaccination against COVID-19 may be a requirement for this job in compliance with current client and governmental policies. A Kelly recruiter will confirm and share more details with you during the interview process.

**Why Kelly** **** **Science & Clinical?**

Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the worlds most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goalsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise noticed.

**About Kelly** ****

At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.

Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kellys Human Resource Knowledge Center.
Kelly complies with the requirements of Californias state and local Fair Chance laws. A conviction does not automatically bar individuals from employment.
Posted: 2022-08-26 Expires: 2022-10-27

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Quality Assurance Regulatory Manager

Kelly Services
Indianapolis, IN 46202

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