Senior Regulatory Affairs Associate / Regulatory Affairs Consultant, FSP (Genera

Parexel International Corporation; Auckland; On-site; NZD 80,000 - 110,000; Full time

Job summary

An established industry player is seeking a Senior Regulatory Affairs Associate to join their FSP team. This role involves providing operational support during the IND/NDA maintenance stage, ensuring compliance and quality of submissions to regulatory bodies. The ideal candidate will have a strong background in Regulatory Affairs, with at least 3 years of experience in the pharmaceutical or biotech industries. This position offers a unique opportunity to engage with clients and contribute to the development of regulatory strategies in a dynamic environment. If you are passionate about regulatory affairs and thrive in a collaborative setting, this role is perfect for you.

Qualifications

• 3+ years in Regulatory Affairs with experience in IND, NDA submissions.
• Knowledge of FDA and EMA processes and regulations.

Responsibilities

• Provide consulting services to address client issues and achieve objectives.
• Guide project team members on technical and process issues.

Skills

Regulatory Affairs

Consulting

Project Management

FDA Regulations

EMA Regulations

Client Engagement

Education

Bachelor’s Degree in a Scientific Discipline

Advanced Degree

Job description

We are seeking an experienced Regulatory Generalist to join our FSP team as a Senior Regulatory Affairs Associate / Regulatory Affairs Consultant. The role involves working closely with a dedicated client to provide operational support during the IND/NDA maintenance stage. The successful candidate will offer regulatory guidance for developing submissions, ensure the quality and compliance of documents submitted to the FDA, and possess a comprehensive understanding of consulting models and services within the regulatory field.

Key Responsibilities

1. Provide consulting services within broad project guidelines to address client issues and achieve objectives.
2. Guide project team members on technical and process issues.
3. Ensure timely completion of work within scope and quality expectations.
4. Identify and qualify new client opportunities.
5. Work independently or within a team, managing issues and conflicts effectively.
6. Prioritize workload, improve project efficiency, and leverage past project information.
7. Review and produce quality work that meets client and company standards, mentoring junior staff as needed.
8. Manage small to larger projects, collaborating with project support staff.
9. Act as a trusted advisor to clients and colleagues, facilitating decision-making and developing tailored solutions.
10. Engage professionally at various organizational levels, including senior management.
11. Identify opportunities for additional business and scope expansion.

Candidate Profile

1. At least 3 years of experience in the pharmaceutical, biotech, CRO, or life sciences consulting industries, with prior CRO experience preferred.
2. 3+ years in Regulatory Affairs, with experience in preparing and reviewing IND, CTA, MAA, NDA submissions.
3. Experience with drug information documentation, post-approval variations, and NDA/MA submissions.
4. Knowledge of FDA and EMA processes, regulations, and interactions.
5. Experience with project lifecycle management, with a preference for those with small molecule experience.
6. Familiarity with US and EU regulatory requirements, including pre/post approval submissions, INDs, and aggregate reporting.
7. Educational background: Bachelor’s Degree in a Scientific or Technical Discipline; an advanced degree is preferred.
8. Language skills: Fluent in spoken and written English.
9. Employment contingent on COVID-19 vaccination disclosure and proof, if applicable.