Regulatory Affairs Cmc Jobs in Arkansas

Develop and manage budgets for CMC operations, ensuring cost-effectiveness while maintaining high-quality standards

Forecast and manage the supply of drug product for clinical trials

A minimum of 10-12 years experience in pharmaceutical or biotechnology CMC development with regulatory interactions experience

Excellent cross-functional leadership, team building, and communication skills

Proven experience in tech transfer, manufacturing scale-up, and validation of biotechnology products

Hiring Manager Interview (45 minutes)

Provide training to company managers and other relevant team members in areas related to regulatory compliance and associated best practices;

Conduct thorough research and stay up-to-date with US regulatory requirements, guidelines, and industry best practices pertaining to healthcare products and pharmaceuticals.

Minimum of 5 years of experience as a Regulatory Affairs Consultant in the healthcare industry, with a focus on US regulations;

In-depth knowledge of US FDA regulations and guidelines for drug and medical device development and approval processes;

Exceptional research, analytical, and problem-solving skills;

Excellent written and verbal communication skills;

Bachelors degree in a scientific discipline or relevant experience (post-graduate degree is preferred but not a requirement)

Experience working within US regulatory affairs within the pharmaceutical or healthcare industry

Experience of regulatory submissions and approvals, including new BLAs/NDAs

Experience with licensing including negotiating directly with the FDA

Salary - $150,000 to $160,000 plus excellent bonus and benefits

across their entire business. As part of this growth, the business is looking to hire an experienced

Assist departmental management in providing regulatory guidance to other departments (QA, QC, Manufacturing, Technical Services, etc.) for planned changes.

Position functions autonomously and consults with departmental management on an as-needed basis.

Position is remote, but expected to be a normal office situation occurring during typical US business hours.

Access – Providing high quality trusted medicines regardless of geography or circumstance;

Leadership – Advancing sustainable operations and innovative solutions to improve patient health; and

Partnership – Leveraging our collective expertise to connect people to products and services.

· Experienced in authoring of assessment reports and Part2/ Expert reports for Dossiers

· Knowledge ofregulatoryguidelines and relevant applications.

· Demonstrate effective leadership, communication, interpersonal skills, and soft skills.

Inviting applications for the role of CMC 3 Manager-RegulatoryAffairs !

Qualifications we seek in you!

• Proven and relevantregulatoryaffairs experience in pharmaceutical, vaccine, or biological products; or related fields

BS in a quantitative or scientific discipline with 4+ years of relevant data science/analytics experience in the pharmaceutical industry

Experienced with computer languages (R, Python, SQL, etc.) and statistical software packages (JMP, Statistica, Minitab, etc.) to manipulate and analyze data

Experienced with business informatics tools (e.g. Tableau, Power BI, Spotfire)

Prior experience working in a GMP environment and understanding of bioprocessing unit operations is a must

Drive and support data pipeline initiatives

Engage with the delivery of new process analytics tools cross-functionally

Experience with prep and filing of the following applications: FDA IND/ANDA/NDA/BLA applications and maintenance submissions

Experience with leading cross-functional teams

As the roles can range, it would be ideal to have experience with the following:

5+ years in Regulatory Affairs (ex: generics, prescription drugs and biologics)

May require up to 10% travel

This would be a contract role, and they are open to either full-time or part-time capacity.

Knowledge or experience with regulatory requirements in other regions and familiarity with GMP regulations is a plus.

In-depth knowledge of ICH requirements and regulatory requirements in the US/EU.

Proficiency in authoring complex technical documents, including CTD M2 and M3 sections, and life cycle management.

8+ years of experience in regulatory CMC within the pharmaceutical or biopharmaceutical industry.

Excellent oral and written communication skills are essential.

Detail-oriented, self-motivated, and comfortable handling broad responsibilities in an entrepreneurial, fast-paced environment.

Maintains current knowledge of regulations and guidelines (FDA, ICH, and others as required).

5-10 years experience in regulatory CMC

Coordinate and lead the task of drafting responses to CMC-related questions from FDA or foreign health authorities.

Work with functional groups to provide timely responses to CMC questions from regulatory authorities.

Coordinates activities for meetings with FDA and other regulatory authorities.

Coordinates with cross-functional teams to define contributions to submissions.

•Strong leadership qualities including strategic thinking, innovation, people management, project management and excellence in communication

Position - Senior Manager (SM) Regulatory Affairs CMC (Small molecules)

•Manage post approval changes where needed

Qualifications we seek in you!

•Prior experience in big (or mid-size) Pharma companies

•Robust communication and presentation skills