Senior / Regulatory Affairs Consultant - CMC

Excellent opportunity for an experienced CMC Regulatory Affairs professional to bring your talent, excellent communication skills, strong writing experience, and CMC expertise to Parexel Consulting as a Senior / Regulatory Affairs Consultant!

In this highly visible as a Senior / Regulatory Affairs Consultant role, you will partner closely with a large multinational pharmaceutical company to ensure successful planning, review and preparation of CMC (chemistry, manufacturing and control) components of investigational new drugs, new drug license applications and related progress reports, amendments, supplemental applications, and continued maintenance of approved marketed products.

Responsibilities:

1. Assist in the technical review and preparation of various investigational drug, marketing applications and other formal reports for submission to regulatory agencies

2. Ensure that the content and structure of documents meet established regulatory requirements

3. Liaise as CMC representative across functional groups, program teams, international regulatory groups and business partners, propose solutions at level of personal technical experience and identify issues that may delay project timelines

4. Maintain Regulatory CMC documentation

5. Maintain related databases and submission schedules

6. Assist in developing submission plans and project timelines

7. Assist in the preparation and interactions with regulatory agencies regarding drug submissions, responding to inquiries and during regulatory agency inspections

QualificationsAt least 7+ years relevant experience in the pharmaceutical industry or a regulatory authority in a CMC review capacity, with at least 5+ years of relevant experience for a Senior Regulatory Affairs Consultant. At least 5+ years relevant experience in the pharmaceutical industry or a regulatory authority in a CMC review capacity, with at least 2+ years of experience relevant experience for a Regulatory Affairs Consultant.

• Successful experience in delivering CMC sections of marketing authorizations, investigational drugs and LCM of commercial products

• Broad background of registration experience gained from working in the pharmaceutical industry or a regulatory authority.

• Knowledge of global guidance, regulations and ICH/GMP requirements

• Ability to work, with accountability, both independently and within project teams or committees to attain group goals and key project milestones.

• Demonstrated competency in planning, project management and tracking projects of high complexity and risk with clearly defined critical paths.

• Proven ability to manage projects across global locations/time zones. Proven ability to create strong, productive working relationships in a global setting with many different cultures.

• Enthusiastic orientation to teamwork. Works inclusively and collaboratively, effectively and efficiently with others internally and externally.

This role may require <15% travel to client location in the future as needed

EEO DisclaimerParexel 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 origin, disability or protected veteran status.