A fast growing company is looking for a Director, Regulatory Affairs. In this role, the candidate will:
- Assumes a leadership role in preparing the corporation for pharmaceutical and device-oriented submissions and compliance audits.
- Ensures compliance of company quality systems to regulatory requirements: including but not limited to Quality Systems Regulations (USA), ISO 13485, GMP and other country specific regulations where the company has commercial interests.
- Assists in performing audits and special investigations as required.
- Recommends strategies for fast track approvals of clinical trials and marketing applications and keeps abreast of regulatory procedures and changes.
- Develops and executes Departmental objectives for the improvement of corporate systems, including the development and implementation of policies, procedures and regulatory/quality company standards
- Prepares, manages and presents study and submission budgets, plans and project timelines.
- Prepares documents for regulatory submissions, internal audits, and inspections, including responsible for the coordination and preparation of materials required in submissions, license renewals, and annual registrations.
- Interacts with regulatory authorities and bodies, as required.
- Interacts effectively with team members and participates at project team meetings (PTM).
- University Degree in science or health related discipline;
- Minimum of seven-year experience in the pharmaceutical industry and a minimum of three years in the medical device industry;
- In-depth working knowledge of regulatory requirements and procedures for pharmaceutical products and medical devices;
- Very strong ability to manage multiple tasks with competing priorities in a demanding, fast-paced and entrepreneurial environment;
- Highly developed interpersonal skills with the ability to work equally well independently and in a team environment;
- Candidate also has led a multidisciplinary team in test protocol design, execution and analysis; developed and executed quality objectives for product development and manufacturing of single use medical devices as well as medical equipment;
- Proven track record in regulatory work demonstrated by significant accomplishments and/or approvals;
- Proven track record in the successful completion of quality certifications (ISO, GMP or QSR) and audits;
- Results-oriented professional with the ability to think strategically and creatively;
- Dedicated self-starter with strong organizational skills and committed to the achievement of objectives;