Pharmaceuticals, Quality/Risk Management, Research & Development, Submission & Registration
4 Year Degree
Manage FDA and international submissions for new drug and abbreviated new drug products and product changes to ensure timely approval for market release in accordance with applicable regulations, standards, and guidance. Maintain regulatory affairs application files to support compliance with requirements and standards. Interact and respond to regulatory agencies. Supervise regulatory affairs specialist.
ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.
Review, prepare (as necessary) and submit New Drug Applications (NDA), Abbreviated New Drug Applications (ANDA), NDA or ANDA amendments and supplements, DMF, NDA or ANDA Annual Reports in accordance with FDA requirements.
Ensure regulatory compliance with relevant regulations and effectively manage timely submission to the regulatory authorities.
Manage the preparation of applications and subsequent regulatory documents, pre and post approval in accordance with agreed timeframes.
Ensure submission readiness of all regulatory documents related to the project.
Develop regulatory strategies and provide regulatory input with cross-functional teams during the drug life-cycle. Serve as the Regulatory Affairs representative on internal and external project teams.
Determine risk assessment and implement regulatory strategies for products in pre and post-approval stages.
Coordinate and author amendments to deficiency letters to obtain drug application approvals.
Perform Regulatory review and ensure that change management activities for pre and post approval products are executed properly and on-time.
Keep abreast with current FDA guidances/recommendations.
Assess, review and approve change control documentation.
Manage direct reports.
Assist in developing and mentoring Regulatory Affairs Specialists.
Act as the FDA point of contact for NDA/ANDA applications, coordinate teleconferences/meetings and prepare responses to all requests for information from FDA.
Participate in strategic planning and due diligence activities.
Adhere to local and global SOPs to meet pre-established project milestones and timelines
Write Regulatory SOPs as required.
Within area of responsibility, understand and comply with all DPT safety, environmental and quality practices and procedures as outlined in organizational/departmental guidelines and SOPs as well as applicable federal, state and local regulations.
Perform other duties as assigned.
Requires supervision of direct reports and requires assigning responsibility to direct reports.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
EDUCATION and/or EXPERIENCE:
Bachelor’s (B.S.) degree in a scientific area of specialty is required.
Minimum 5-7 years of regulatory related experience with generic and new drug applications and application maintenance filed with the FDA is required.
Wide-ranging managerial and leadership skills required.
Strong knowledge of NDA, ANDA, MAA, and IND submissions is required.
Working knowledge of cGMPs is required.
Employer will assist with relocation costs.
Additional Salary Information: Bonus Eligible
Internal Number: DPT90002018
About DPT Laboratories, a Mylan Company
As a leading contract development and manufacturing organization (CDMO), DPT is recognized for its excellence in semi-solid and liquid dosage forms. Founded in 1938, DPT helps you investigate and identify the best development and manufacturing solutions for your products. Backed by a team of more than 1,200 employees working at advanced, purpose-built Centers of Excellence in San Antonio, DPT has the resources and capacity to efficiently serve your pharmaceutical development and manufacturing needs no matter the scope. From virtual to large pharma, and concept to commercialization, DPT remains committed to exceeding your expectations for quality and service.
No other company offers a 75+ year history of financial strength, stability, technical expertise and regulatory merit in semi-solids and liquids.