- Lead regulatory agency engagements to aid the development of robust global regulatory strategies.
- Responsible for the planning, preparation, and review of content for submissions to Regulatory Agencies (e.g., INDs, CTAs, meeting requests and briefing books, IND safety reports, annual reports) and coordinate responses to Regulatory Agency requests for assigned programs, ensuring timeliness, accuracy, comprehensiveness, and compliance with regulatory standards.
- Provide expertise in translating regulatory requirements into practical, workable plans, developing regulatory strategies with the team based on clinical trial data, current regulations, and regulatory landscape of competitive products.
- Work closely with company leadership and ensure that company practices conform to Regulatory Agency requirements by establishing internal documentation, control, and validation procedures.
- B.S. or graduate degree, preferably in Biological/Life sciences. Certification in Regulatory Affairs (RAC) is a plus.
- 8+ years of regulatory affairs experience in drug development and product registration activities within the pharmaceutical or biotech industry in multiple phases of development; both big and small company experience is preferred.
- Evidence of being a critical strategic thinker who is solution oriented with the ability to think outside of the box; preference for demonstration of such mindset within rare disease programs.
- Full functional knowledge of regulatory requirements (regulations, directives, and guidance/guidelines) pertaining to the development and registration of drug products in multiple ICH regions.
- Ability to set priorities, work independently, and deliver results in a timely manner and ability to adapt and react to new information or changing priorities.
- Strong organizational and planning skills, and ability to communicate effectively and efficiently to multiple audiences.
- Hands-on experience on the submission of IND, NDA, response development to review questions.
- Must be located within and authorized to work in the United States today and in the future
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Director, Regulatory Strategist – Global Regulatory Lead - Boston, United States - PepGen
Description
PepGen is a biotechnology company advancing next-generation oligonucleotide therapies for neuromuscular diseases. Our ambition is to unlock the potential of nucleic acid therapeutics by leveraging the drug delivery capabilities of our proprietary Enhanced Delivery Oligonucleotide (EDO) platform. We are applying this technology across a wide range of indications and are rapidly growing our team at our U.S. headquarters in Boston, Massachusetts.
PepGen is at an exciting time in our development. Reporting into the VP Head of Regulatory, you will be responsible for the global regulatory strategic development for one of our lead assets, providing a unique opportunity for a motivated and team-orientated individual who flourishes in an environment where they can help lead and shape our future.
As an integrated member of the PepGen Team you will lead, develop, and implement robust global regulatory strategies and provide advice on the development and life cycle management of investigational products, preparing and managing regulatory documents, submissions, collaborating effectively with internal and external stakeholders including leading health authority interactions.
Skills and Competencies
Qualifications
EEO Statement
PepGen is an Equal Opportunity Employer committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status.
Note: This is not a remote role. We like to work together and operate in a hybrid model in office Tues, Weds & Thurs each week.
Recruitment & Staffing Agencies: PepGen does not accept unsolicited agency resumes. Currently, we are working exclusively with The Bowdoin Group for all our recruiting needs. Thank you.
