Associate Director, Global Regulatory Affairs
Position Summary
The Associate Director, Global Regulatory Affairs (GRA) is responsible for the preparation, coordination, and management of simple and complex regulatory submissions for North America (US and Canada). The Associate Director works independently and within group settings to act as a liaison between GRA and other functional areas, including external CROs, partners, and consultants in the planning, organizing, and preparing of regulatory documents for submission to health authorities serving as the point of contact for applicable health authorities.
Roles and Responsibilities
- Actively leads the development and implementation of regulatory strategy for assigned projects.
- Coordinates all aspects of regulatory submissions relevant to assigned programs, including coordinating regulatory workflow, reviewing technical documents (clinical and nonclinical), developing and tracking submission timelines, and supervising preparation of regulatory submission to ensure compliance with FDA regulations and guidelines.
- Act as a key point of contact with the FDA and other regulatory agencies.
- Coordinate with Regulatory Project Management the development of reliable submission plans and timelines.
- Support GRA activities with other functional areas as required including representing GRA in cross-functional team meetings.
- Monitor company progress toward fulfillment of regulatory commitments.
- Contribute to local process improvements and initiatives to improve overall efficiency, quality and/or output within GRA, including the authoring and review of standard operating procedures (SOPs).
- Serve as a leader within GRA to help drive best practices.
- Remain current on regulatory requirements (e.g., Domestic and International) that may impact the regulatory strategy and clinical operations related activities.
- Translate and present pertinent evolving regulatory requirements to GRA and to internal/external functional business units as needed.
Educational Requirements:
- Bachelors or Master’s Degree in a scientific discipline or equivalent will be considered; Regulatory Affairs Certification is favorable
Professional Work Experience Requirements:
- Minimum of 8 years of regulatory experience respectively within the pharmaceutical or biotechnology industry
Experience and Skills:
- Experience with global clinical trial regulations, including submission of Clinical Trial Applications (CTAs) to global regulatory agencies and management of regulatory aspects of clinical trials in accordance with Good Clinical Practices (GCP) requirements
- Experience communicating directly with regulatory agencies in meetings and correspondence from early development through post approval
- Must have a solid understanding of FDA, EMA and International regulations and ICH guidance, as well as comprehension in the drug development process.
- Experience preparing and overseeing regulatory submissions in North America (US and Canada), including INDs, CTAs, and Marketing Applications in electronic Common Technical Document format
- Knowledge of Common Technical format
Other skills/Attributes:
- Excellent interpersonal, verbal and written communication skills
- High emotional intelligence and self-awareness
- Able to work effectively in a cross-functional environment
- Detail-oriented and highly organized
- Works independently and under tight deadlines
- Comfort with ambiguity
- Able to resolve conflicts in a positive and collaborative manner
- Constantly looks for ways to improve (processes, own behaviors)
- Able to manage up and down
- Demonstrated alignment with Amicus Mission Focus Behaviors
- Passion for rare disease and patient focused
Location:
- Preferred location is Princeton, NJ (with a hybrid work approach)
We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all. Our unique experiences, backgrounds and range of cultural perspectives enrich how we approach opportunities, pushing ideas as far and as fast as possible with patients always our top priority. Employee expertise, intelligence, and creativity drives our innovation, and our passion and commitment to excellence. Our “Three Pillars of DEI” are interwoven into our Amicus culture and expands one person, one word, and one act at a time. For our employees, these three pillars are a touchstone for inspiration, guidance, and encouragement.
Amicus is an Equal Opportunity Employer and will judge all applicants based on their qualifications for the job, without regard to race, color, sex, religion, national origin, age, disability, sexual orientation, gender identity, protected veteran, disability status or any other characteristics protected by applicable federal, state or local law.