Senior Director Regulatory Affairs
Senior Director, Regulatory Affairs
The Senior Director, Regulatory Affairs provides strategic regulatory guidance to cross-functional project teams responsible for product development and post marketing commitments. He/she defines and implements global regulatory strategies, translating regulatory requirements into practical, workable plans in order to facilitate timely drug development and registration. The Senior Director, Regulatory Affairs works with cross-functional project teams to execute the agreed-upon strategies; interacts with regulatory agencies to negotiate agreements; coordinates the planning and conduct of regulatory agency meetings; and supports departmental activities with regards to clinical trial conduct and regulatory submissions.
- Actively leads development and implementation of regulatory strategy plans and activities for assigned programs and coordinates strategy with RA project management for assigned regulatory projects.
- Ensures the overall program execution of high quality, effective IND, NDA and MAA and related regulatory submissions and responses to regulatory agency requests:
- develops and tracks submission timelines with RA Project Management
- actively participates in product development project teams advising on submission preparation timelines, processes, and requirements
- coordinates regulatory workflow
- prepares paper and electronic submissions in cooperation with Regulatory Publishing to support development project plans and timelines
- works closely with Regulatory Publishing to ensure electronic Common Technical Document (eCTD) compliance
- reviews and approves protocols, reports, and various documents and materials (e.g., CMC, clinical, nonclinical) used in regulatory submissions to ensure compliance
- reviews and leads preparation of IMPD to support international CTA submissions
- oversees preparation of regulatory submissions to ensure compliance with all FDA regulations and guidelines.
- Serves as primary contact for assigned projects with the FDA and other regulatory agencies:
- establishes and maintains contacts and effectively partners with FDA, DEA and other federal agencies to direct, co-ordinate and implement preparation of all regulatory submissions and provide regulatory support across all areas
- plans, executes and leads successful regulatory agency meetings and interactions per regulatory strategy
- Identifies and monitors legislative, regulatory and policy issues. Develops risk assessment plans. Develops and presents information to educate internal stakeholders about risk (e.g., corporate evaluations on regulatory risk-benefit, options for risk mitigation).
- Develops and implements registration strategy plans (RSP) and ensures cross-functional alignment with overall development plan.
- Acts as liaison between Regulatory Affairs and other functional areas, including external contractors (e.g., CRO teams and vendors); participates as a key member of Global Regulatory Project Teams; and represents Regulatory Affairs on various other process and procedural cross-functional teams.
- Works with development partners as required; assists in due diligence activities.
- Provides regulatory support for Quality Assurance and Pharmacovigilance inspection ready efforts; and provides regulatory oversight during follow-up to inspections and audits to minimize potential for findings of non-compliance.
- Participates in review of promotional and advertising materials as required.
- Develops and maintains current regulatory knowledge and provides guidance to regulatory staff and company management; identifies the need for new or expanded regulatory policies, processes and SOPs, and approves and ensures implementation to establish a compliant culture.
- Provides leadership and guidance by promoting teamwork, discerning hiring needs, as well as coaching, mentoring, training and developing regulatory staff and other team members.
- Bachelors or Masters Degree in a scientific discipline or equivalent.
- Strongly preferred: PhD or PharmD or equivalent experience; Regulatory Affairs Certification.
- Minimum of 10-15 years of regulatory experience within the pharmaceutical or biotechnology industry.
- Experience managing direct reports.
- Proven track record designing and executing creative development strategies and programs for drugs, biologics/vaccines and also in the rare disease space.
- Comprehensive experience in the drug development process in the US and internationally (particularly in Europe and Japan).
- Experience in the post marketing area and related requirements.
- Experience preparing and overseeing regulatory submissions, including INDs/Clinical Trial Applications and Marketing Applications in eCTD format.
- Preferred: Experience with international clinical trials and associated regulatory documentation.
- Solid understanding and applied knowledge of regulatory requirements (FDA, ICH) for the development and approval of investigational products.
- Excellent communication (written and verbal) skills; proven ability to deliver effective presentations concerning complex topics.
- Detail-oriented with the ability to detect and correct errors and/or inconsistencies in a variety of documents.
- Proven ability to collaborate across multiple functions and build effective relationships within a team/collaborative environment, with a high level of professionalism.
- Willingness to travel up to 5% domestically and Internationally.