The Associate Directory, Regulatory Affairs is a subject matter expert on the regulatory requirements for promotional and non-promotional marketing material, and is responsible for assisting the Director, Regulatory Affairs in the overall Regulatory Affairs programs for the company's products. This person shares responsibility for ensuring:
Company promotional materials are reviewed, approved and submitted to FDA in compliance with applicable regulations.
Post marketing reports (e.g., Patent notification, PADERs, Annual Reports, safety reports) are reviewed and submitted in compliance with applicable regulations.
Design and manufacturing changes are reviewed/approved and associated regulatory submissions are drafted and submitted as appropriate
FDA correspondence is reviewed, filed, and communicated internally.
Fees associated with regulatory dossiers are paid on a timely basis and periodic communication with associated administrative bodies are completed to ensure accurate information is maintained.
Provide regulatory leadership and guidance to internal stakeholders during the development, review, and approval of marketing materials.Ensures regulatory compliance while effectively managing business risks.
Ensure timely and accurate submission of promotional materials to OPDP.
Maintain up-to-date knowledge of the US regulatory promotional environment by reviewing guidance documents, enforcement letters, and participation in industry meetings.Communicate and advise internal stakeholders as necessary.
Provide promotional advice and guidance on the development of draft labeling to ensure commercially viable US labeling upon which future promotion will be based.
Fosters and facilitates teamwork within the kaléo review committee process.
Participates in US labeling negotiations and FDA meetings as necessary.
Maintains awareness of competitor’s activities and product labeling and communicates regulatory intelligence to internal stakeholders as necessary.
Develop and implement regulatory strategies to facilitate the progress of programs in all phases of development including post-approval changes and regulatory reporting.
Provide Regulatory guidance and support for the company's development and commercial products.
Support the Regulatory Affairs team leads efforts in drafting and submitting INDs, NDAs, CTAs, 51Oks, BLAs and MAAs in different regions around the world, including CMC, nonclinical, human factors, clinical and pharmacovigilance activities.
Establish and meet timelines for regulatory submissions.
Conduct conference calls, meetings, and presentations with Regulatory Agency reviewers and/or inspectors as needed.
Ensure applicable Regulatory Standard Operating Procedures are in place to facilitate compliance with applicable regulations.
Recruit , retain, and develop regulatory tam members, contractors, and consultants as needed to meet organization needs.
Others duties as assigned.
Bachelor's or Master's or advanced degree in a scientific discipline, with a minimum of 8 years of increasingly responsible regulatory experience in the pharmaceutical, biotechnology and/or medical device industry.
Deep and broad knowledge of US regulatory affairs with an emphasis on regulations and guidance documents governing labeling and advertising/ promotion.
Excellent verbal and written communication skills.
Direct experience with pharmaceutical regulatory submissions, including electronic submissions, and product approvals worldwide.
A proven track record of effective collaboration with regulatory agencies, including the FDA.
Ability to work with minimal supervision, to set priorities to meet timelines, to motivate others, and to manage budgets.
Ability to work independently with strong problem solving, negotiation, and decision-making skills by balancing autonomy and teamwork.
Ability to work collaboratively across functional teams with solution-oriented approaches to problems.
Evaluative, analytical and interpretative skills enabling review and synthesis of reports and other documents used in regulatory planning and submissions