Regulatory Affairs Consultant, FSP (biologics/rare disease)

Full Job Description

When our values align, there's no limit to what we can achieve.
 
At Parexel, we all 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 what we do.

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

Amazing opportunity for an experienced Regulatory Affairs Consultant to work closely with a mid-sized pharmaceutical client as they continue to identify treatment options for those with unmet medical needs! If you are experienced with rare disease regulatory strategies and filings, we would love to connect!

The Consultant, Regulatory Affairs provides strategic global regulatory guidance to cross-functional project teams responsible for product development.  The successful candidate has experience in the development of drugs, biologics/vaccines, and in the rare disease space.  In this role, the Consultant with support from the Senior Director, Regulatory Strategy, defines and implements regulatory strategies; works with cross-functional project teams to execute the agreed-upon strategies; and supports departmental activities with regards to clinical trial conduct and regulatory submissions.

KEY RESPONSIBILITIES

• Actively leads the development and implementation of regulatory strategies for assigned programs and ensures cross-functional alignment.

  • Coordinates regulatory activities (CMC, nonclinical, and clinical) to assure timelines and milestones.

  • Provides Regulatory Risk Assessment (RRA) during various phases of product development.

  • Monitors current and proposed regulatory and legal issues and ensures that key initiatives are communicated to the stakeholders.

• Monitors/ensures all aspects of regulatory submissions relevant to assigned projects.

  • Supervises the preparation of regulatory submissions to ensure timely submission and compliance with regulations and guidelines.

  • Reviews and approves (when necessary) documents used in regulatory submissions.

  • Participates in preparing IMPDs to support international CTA submissions. 

• Reviews technical documents (Clinical, Nonclinical, CMC).

• Provides Regulatory support as a key member of Global Regulatory Project Teams.

• Leads multidisciplinary team responding to Health Authority questions during the IND and NDA review phases for assigned projects.

• Acts as liaison between Regulatory Affairs and other functional areas, including external contractors (e.g., contract research organization teams and vendors).

• Maintains knowledge and monitor changes in pertinent laws, regulations and guidance. Interprets external developments and inform/educate internal stakeholders. 

• Identifies the need for new regulatory processes and SOPs, approves and ensures implementation.

• Works closely with Regulatory Operations to ensure e-CTD compliance.

QUALIFICATIONS

Education:

• B.S. degree in a scientific discipline.

• M.S. or equivalent experience is preferred.

Professional Experience:

• Minimum of 7 years of regulatory experience respectively within the pharmaceutical or biotechnology industry.

• Experience designing and executing creative development strategies for NCE and biologics development programs.

• Experience preparing and overseeing regulatory submissions, including INDs/Clinical Trial Applications and Marketing Applications in eCTD format.

• Experience with international clinical trials and regulatory documentation.

• Experience in preparation of critical submission documentation.

• Experience leading multidisciplinary teams.

Knowledge and Skills:

• Comprehensive understanding of FDA regulations and ICH guidance, as well as comprehensive experience in the drug development process. 

• Expertise in translating regulatory requirements into practical, workable plans.

• Excellent communication (written and verbal) and collaboration skills.

• Ability to build effective relationships within a cross-functional team environment with a high level of professionalism.

• Detail-oriented.

• Willingness to travel as required within a global work environment.

Due to the location of the Client and Client Team meetings, East Coast candidates are highly preferred.

EEO Disclaimer
Parexel 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.