Senior Director, Regulatory Affairs
COMPANY is a publicly traded biotechnology company pioneering innovative medicines to help millions of patients worldwide overcome and prevent difficult-to-treat infections that are becoming increasingly drug-resistant. They marketed product and strong pipeline.
They are seeking an experienced Senior Director, Regulatory Affairs. Company located in Jersey City, NJ and will consider this person to work from home as long as they could be in office at least one or two days a week (preferable Tuesday or Wednesday or Thursday OR every other week for a few days). MAY consider coming in just once a month for entire week. We are committed to positively impacting the lives of patients by developing innovative therapies, come join us and make a difference.
The Senior Director, Regulatory Affairs is responsible for providing subject matter expertise on matters related to global regulatory activities, as well as providing leadership for the growth and responsibilities of the regulatory department. The Senior Director will represent COMPANY in key stakeholder and strategy meetings on regulatory matters related to medical product development and commercialization, including meetings with executive leadership, meetings with the Food and Drug Administration (FDA) and other regulators. This role leads preparation, review and submission of documents to the FDA and other regulatory authorities to support product development leading to marketing authorization and lifecycle management. This role combines scientific, regulatory and business knowledge to assure that COMPANY products are developed and distributed according to all applicable regulations in alignment with the company’s strategic goals. The role requires a mastery of medical product regulations to develop efficient solutions to the evolving regulatory needs of the industry.
- Secure US and global regulatory marketing authorization for new products, product updates and product expansions. This includes preparation and filing of submissions, responding to regulatory authorities and auditors, and leading meetings with regulatory authorities.
- Develop and implement a comprehensive set of policies, processes and SOPs in support of the organizations regulatory responsibility.
- Formulate regulatory strategies for pipeline products.
- Anticipate regulatory obstacles and emerging issues throughout the product lifecycle and develop strategies for resolution.
- Perform global regulatory intelligence including monitoring regulatory updates, workshops, discussions, and other news sources.
- Advance internal awareness of current and upcoming regulations, requirements, and expectations, and identify training and educational needs for the organization.
- Manage processes involved with maintaining annual licenses, registrations, and listings.
- Serve as an internal go-to subject matter expert on regulatory and quality matters.
- Represent the company in external meetings on regulatory matters, including with regulators and auditors and development partners.
Requirements and Preferred Skills:
- Advanced Life Science Degree required (PharmD, PhD, MD, MA)
- 15+ years of experience in regulatory affairs. Progressive responsibility and leadership
- A comprehensive understanding and experience with implementation of medical product regulations, particularly all relevant sections of Title 21 of the US Code of Federal Regulations
- Knowledge of global regulatory agencies/processes/regulations
- Record of successful medical product filings such as INDs, NDAs, BLAs, MAAs
- Excellent writing and oral communication skills
- Ability to form and maintain working professional relationships with external stakeholders, regulatory authorities and scientific and clinical advisors
- Prior experience and demonstrated ability to work in diverse therapeutic areas
- Strong leadership skills with ability to set a vision, lead change, grow a team and mentor others
- Experience leading regulatory authority communications and meetings
- Employment is contingent upon satisfactory results of a pre-employment background check, drug screen, proof of full COVID-19 vaccination and proof of COVID-19 booster vaccination