Regulatory Affairs Head

Location: San Ramon, CA, USA - On-site

Hiring Company Name: ACHNET Demo

Hiring Company Location: San Ramon, CA, USA

Job Type: Full-time

Experience Level: Senior Level, 10+ years

Job Overview

We are seeking a highly experienced and strategic Regulatory Affairs Head to lead our regulatory affairs function. The ideal candidate will have a strong pharmaceutical background with extensive experience in formulations and a proven track record of successful regulatory submissions in both the European and US markets. This role requires a deep understanding of regulatory requirements, excellent leadership skills, and the ability to develop and implement regulatory strategies that support our business objectives.

Key Responsibilities

1. Develop and implement regulatory strategies for new and existing products in the US and European markets.
2. Lead and manage the preparation and submission of regulatory filings, including INDs, NDAs, and MAAs.
3. Maintain a thorough understanding of current and emerging regulatory requirements and guidelines.
4. Serve as the primary point of contact with regulatory agencies, including the FDA and EMA.
5. Provide regulatory guidance and support to cross-functional teams, including R&D, manufacturing, and marketing.
6. Oversee the development and maintenance of regulatory documentation and databases.
7. Ensure compliance with all applicable regulations and standards.

Educational Qualifications

1. Bachelor's degree in a scientific discipline (e.g., Pharmacy, Chemistry) is required.
2. Advanced degree (MS, PhD, or PharmD) is preferred.

Must-Have Skills

1. Extensive experience in regulatory affairs within the pharmaceutical industry.
2. In-depth knowledge of US and European regulatory requirements for pharmaceutical products.
3. Proven track record of successful regulatory submissions (INDs, NDAs, MAAs).
4. Strong understanding of pharmaceutical formulations and manufacturing processes.
5. Excellent communication, leadership, and interpersonal skills.
6. Ability to work effectively in a fast-paced, dynamic environment.

Good-to-Have Skills

1. Experience with regulatory affairs in other international markets.
2. Experience with electronic submissions (eCTD).
3. RAC certification.

Pay Rate/Salary

Commensurate with experience.

Number of Openings

1