Candidates MUST have proven experience in the pharmaceutical industry with regulatory submissions/strategies and in writing SOPs in order to be considered.
This position will have primary responsibility for regulatory strategy development and management with quality components. This is an office-based position located in Collegeville, PA.
The Manager of Clinical Regulatory and Quality Operations will be responsible for the development and implementation of regulatory policies, standard operating procedures, registration strategies and regulatory submissions supporting new and approved medicinal products in North America. The Manager of Clinical Regulatory and Quality Operations will be the primary contact with regulatory agencies in North America. Additionally, he/she will collaborate with European colleagues to assist in the development and registration of medicinal products on a global scale.
Specific Job Duties:
- Develop, implement and maintain regulatory strategies to support market access for existing products as well as unapproved products under development.
- Be the primary contact with regulatory agencies and develop positive working relationships with regulators.
- Conduct all meetings, and teleconferences with Regulatory Agencies and prepare company meeting minutes for archive and / or submission.
- Oversees and participates in the preparation of all submissions to regulatory authorities. This includes pre-IND materials, clinical development documents (e.g., IND related submissions, information amendments, annual reports, safety reports, EU Clinical Trial Applications, IMPD, etc.) and NDA submissions and post approval submissions (annual report, CMC changes, advertising material, labeling changes, non-clinical and clinical data supplement etc.)
- Document and track all correspondence with Regulatory Agencies to ensure timelines are maintained and deadlines achieved.
- Maintain the regulatory files and electronic archives.
- Support global filing activities to Regulatory Agencies, Global regulatory meetings, as well as document requests and team reviews prior to submission.
- Keep current and review standards and FDA guidance for applicability. Communicate these new standards to the company and assist in incorporating changes in regulation into new and established Standard Operating Procedures.
- Work with EU regulatory team to build regulatory strategies and dossiers for US in the frame of post-approval changes request
- Create and maintain internal SOPs and supportinternal policy / procedure reviews.
- Review and advise on proposed product labels, websites, advertising and other communications to ensure they are appropriate and comply with regulatory guidelines. Support regulatory and compliance initiatives
- Build electronic publishing functionality and coordinate publishing tasks with external partner for electronic submission activities (eCTD format)
- Works independently with minimal direction, identifies project needs, creates regulatory project plans, budgets & timelines
- Work to develop and maintain positive working relationships with FDA and Key Opinion Leader experts and consultants
Required Education and Experience
- Prior experience developing relationships and negotiating with regulatory agencies.
- Prior experience creating and maintaining internal SOPs and supportinternal policy / procedure reviews as well as quality operations.
- Knowledge of US, EU and ICH regulatory requirements for the conduct of clinical trials and submission of dossiers supporting approval (CMC, labeling changes, non-clinical and clinical data supplements).
- Experience with eCTD submissions and publishing requirements and the electronic filing of INDs, CTAs for clinical studies; NDA's
- Bachelor's degree (or higher) in life sciences/scientific discipline
- 5-8 years of drug/biologic regulatory affairsexperience
- High level of proficiency in relevant software (i.e., MS Word, Excel, Power Point, MS Office, Adobe, Document Management Systems, eCTD Publishing or similar systems)
- Superior work ethic and desire to create positive experiences and make significant contributions.
- History of leadership and providing sound judgment when making business and regulatory decisions.
- History of creating and maintaining internal SOPs and supportinternal policy / procedure reviews.
- Strategic thinking and problem-solving skills
- Ability to collaborate effectively across a variety of teams and cultures located in multiple locations in demanding/changing situations.
- Strong verbal and written communication skills, with ability to communicate their point clearly and simply.