Regulatory Affairs Project Manager (CMC)

Location: Lake County (open to hybrid)

Contract Length: Through end of the year (possible extension)

Pay Rate: $38-42/hr

Regulatory Affairs Project Manager - CMC (Chemistry, Manufacturing, Control)

Description:

Project manage the overall Chemistry and Manufacturing Control (CMC) Variation process. This includes documenting the agreed-upon regulatory strategy for the CMC change, managing the authoring, reviewing, and approving of the submission documents, and maintaining the timeline.

• Work proficiently in the document approval and archiving repository
• Work with regulatory operations in providing the appropriate documentation for the global roll-out of the CMC Variation.
• Work proficiently in a document approval and archiving repository
• Ensure submission documents are submission-ready formatted.
• Interfaces with Operations CMC Team and Quality Assurance
• Contribute to a positive and motivating work environment that encourages mutual respect, innovation, and accountability at all levels
• Communicate to the Regulatory Affairs (RA) CMC Project Lead any questions or concerns for meeting the timelines
• Balance multiple priorities in a fast-paced, team-based environment and work independently when needed

Qualifications/Experience:

• Bachelor's degree in pharmacy, biology, chemistry, pharmacology, engineering, or related subject.
• 7 years' experience
• Scientific background and knowledge of project management is desirable
• Quick learner of technology applications
• Expertise in MS Office applications including Excel, Word and Sharepoint
• Excellent oral and written communication skills in English
• Organization, attention to details and effective time management with an ability to adapt to changing priorities; Excellent analytical and interpersonal skills
• Competent in application of standard business procedures (standard operating procedures,)
• Ability to work with minimal supervision
• Learns fast, grasps the "essence" and can change course quickly when required

Preferred: Experience in pharmaceutical business and/or science

Our role in supporting diversity and inclusion
As an international workforce business, we are committed to sourcing personnel that reflects the diversity and values of our client base but also that of Orion Group. We welcome the wide range of experiences and viewpoints that potential workers bring to our business and our clients, including those based on nationality, gender, culture, educational and professional backgrounds, race, ethnicity, sexual orientation, gender identity and expression, disability, and age differences, job classification and religion. In our inclusive workplace, regardless of your employment status as staff or contract, everyone is assured the right of equitable, fair and respectful treatment.