Clinical & Regulatory Affairs Program Manager
At Pharmatech Associates, our mission is to fulfill customer expectations throughout the development and execution of tailored, technical, high value, innovation solutions. We are committed to fostering an environment that is professional and forth right. These principles are captured in the values we believe are essential to maintaining our supportive culture and our commitment to our clients’ success. We seek to establish an atmosphere of openness, objectivity, accountability, mutual respect and teamwork so each employee can realize their fullest potential for personal and professional growth. We value work life balance. At Pharmatech talent matters, and we tackle each project with a “no fear” attitude. We stand together as a team, and we’ve got your back. Pharmatech’s commitment to integrity is unwavering.
Reports To: Vice President, Clinical & Regulatory Affairs
The Regulatory Affairs Program Manager is responsible for the overall direction, coordination, implementation, execution, control and completion of specific projects ensuring consistency with company strategy, commitments and goals. This position will have an emphasis on Chemistry, Manufacturing, and Controls (CMC) regulatory strategies and document preparation but will also have exposure to strategic and tactical regulatory affairs activities supporting the clinical and nonclinical projects within Pharmatech’s Regulatory Division. This position will act as the CMC regulatory subject matter expert (SME) on project teams and will help RA and Manufacturing to deliver the CMC sections of relevant IND, BLA, and MAA regulatory submissions. This position includes the following responsibilities:
- Lead activities of Regulatory Affairs sphere with an emphasis on global regulator strategy and the preparation, review and submission of documents to FDA and other Regulatory Health Authorities
- This position will serve as a Regulatory Affairs (RA) CMC SME for the department and manufacturing and quality
- This position develops regulatory strategy, prepares content templates and leads technical teams in preparation of submission documents with RA team supervision. These include CMC focused sections of clinical trial applications/amendments (e.g., IND, IMPD, IB) and marketing applications (BLA, MAA, NDS)
- Work with the Project Managers to collaborate with customers for the development of new products for various diseases/therapies as well as providing the strategic coordination of continuous improvement of existing products
- Formulate regulatory strategies based on current regulatory intelligence
- Oversee implementation of regulatory strategies and activities needed to secure approval of new drugs
- Ensure the coordination, preparation and timely submission of regulatory documents for clients
- Identify gaps in product development plans that may pose regulatory issues
- Provide electronic submission (eCTD) expertise, requirements and guidance
- Lead teams of multi-specialized SME’s consisting of both employees and Independent Contractors engaged to complete all aspects defined projects
- Utilize industry network to grow the Regulatory Affairs sphere on a global basis
- Support global implementation of projects as required
Bachelor’s degree in Science mandatory with a major preferably in life sciences or engineering, e.g., biological sciences, physical sciences, medical science, engineering, chemistry, epidemiology or pharmacy
8-10 years of experience of experience in drug development and regulatory affairs experience in the Pharmaceutical Industry. Medical device and/or device-drug combination product related experience preferred.
Must be capable of applying diversified knowledge of regulatory and technical principles and have the ability to prepare regulatory filings or product launches. Must be proficient with cGMP’s, GLPs, ICH, GDP, CFR and global regulations as appropriate.
Candidate must extensive regulatory experience in drug development and approval processes (NDAs and MAAs) across all phases of development.
- Strong understanding of current FDA trends and requirements
- Experience interacting with health authorities through development, approval and support during commercial
- FDA relationships a plus
- Strong written and oral communications
- Polished and accomplished presenter