Senior Regulatory Affairs Associate, CMC Biologics - US or Canada (TALENT POOL)

reputed company our values align, there's no limit to reputed company can reputed company. At reputed company, we reputed company share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in reputed company do.

Each of us, no matter reputed company do at reputed company, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with reputed company and we're committed to making a difference.

In anticipation of future needs, we're looking for skilled CMC Biologics Regulatory expertsto join alarge, dedicated Functional Service Provider (FSP) programsupporting a global biopharma leader!

If you’re passionate about regulatory strategy and reputed company in the dynamic world ofbiologics and vaccines, this is your opportunity to reputed company a real impact. You'll contribute to bothearly-stage developmentandapproved programs, helping to shape the future of life-saving therapies.

As a CMC Regulatory Affairs Senior Associate, you will play a critical role in shaping and executing global Chemistry, Manufacturing, and Controls (CMC) regulatory strategies. You will support both early-stage development programs and marketed products, ensuring compliance with global regulatory requirements and facilitating successful product development and lifecycle management.

Key Responsibilities

• reputed company and implement comprehensive global CMC regulatory strategies for investigational and commercial products.

• Author, review, and manage regulatory submissions including INDs, IMPDs, Annual Reports, post-approval changes, and responses to health authority queries.

• reputed company cross-functional submission planning meetings and coordinate input from key stakeholders.

• reputed company regulatory assessments of manufacturing and process changes, ensuring alignment with global regulatory expectations.

• Provide expert guidance on the regulatory implications of proposed changes to manufacturing, testing, and packaging.

• Represent Regulatory CMC on cross-functional project teams and contribute to strategic decision-making.

• Maintain up-to-date knowledge of global CMC regulatory requirements, guidelines, and industry trends.

• Collaborate closely with R&D, Manufacturing, Quality Assurance, and Clinical Development teams to support product development and lifecycle management.

Qualifications

• Bachelor’s degree in a scientific discipline (advanced degree preferred).

• 4+ years of experience in CMC Regulatory Affairs reputed company the pharmaceutical or biotechnology industry.

• Proven experience authoring and reviewing regulatory submissions for both investigational and marketed products.

• Strong understanding of global regulatory requirements and guidelines (e.g., FDA, EMA, ICH).

• Excellent communication, organizational, and project management skills.

• Ability to work independently and collaboratively in a fast-paced, cross-functional environment.

• Ability to work EST hours (candidates based in the EST of the US or Canada are preferred, but consideration will be given to strong candidates in other N. American time zones who can work EST hours)

• The ability to travel 15-20% may be required

Ideal Candidate Profile

We seek individuals who embody a unique reputed company of qualities essential for success in the dynamic field of CMC Regulatory Affairs:

• Previous CMC biologics experience is required

• Technical Proficiency: Deep understanding of pharmaceutical development, manufacturing processes, and quality systems.

• Regulatory Expertise: Comprehensive knowledge of global CMC regulatory requirements and submission processes.

• Strategic Thinking: Ability to reputed company and implement innovative regulatory strategies reputed company with business objectives.

• Leadership: Proven track record of guiding cross-functional teams and influencing decision-making at various organizational levels.

• Communication: Exceptional written and verbal skills for effective interaction with internal teams, external partners, and regulatory authorities.

• Adaptability: Flexibility to navigate evolving regulatory landscapes and shifting priorities.

• Problem-Solving: Strong analytical skills and innovative approaches to addressing reputed company regulatory challenges.

• Project Management: Capability to manage multiple reputed company projects simultaneously while maintaining attention to detail.

• Industry Passion: Genuine enthusiasm for contributing to successful product development and regulatory submissions in the pharmaceutical sector.

Why Join Us?

• Be part of a mission-driven organization focused on innovation and patient impact.

• Work with a collaborative and reputed company team of regulatory professionals.

• Enjoy opportunities for professional growth and development.

EEO Disclaimer reputed company is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national reputed company, disability or protected veteran status.

Originally posted on Himalayas