Associate Director of RA

Proclinical is seeking an Associate Director of RA for a leading pharmaceutical company located in New Jersey. The Associate Director, Regulatory Affairs (Respiratory Products) will take primary responsibility for a portfolio of their products, with a particular focus on Respiratory. The candidate will also provide support and oversight of injectable and ophthalmic dosage forms.

Must be eligible to work or be a citizen in the US.

Job Responsibility:

• Responsibility for a portfolio of respiratory products such as DPI, MDI, SoftMist and Inhaled Nasal Delivery Systems throughout the product lifecycle, from pre-development through post approval. Responsibilities include multiple disciplines, including CMC (chemistry manufacturing and controls), labelling, clinical, and submission preparation (SPL and eCTD).
• Directly communicating with FDA project managers, internal team members, and third parties. Collaborating with local and international co-workers to achieve goals and leading such groups with respect to regulatory affairs work.
• Managing the organization, preparation, and review of new ANDAs, amendments, supplements, annual reports and other regulatory documents and correspondence.
• Working with internal and external stakeholders to manage pre- and post-approval changes to the products, including evaluation and approval of change controls.
• Supporting the timely launch of newly approved products, including process validation, communications with quality, sales, and supply chain departments.
• Project management of all outstanding tasks for the portfolio and ensuring that all deadlines are met or exceeded. Maintaining up-to-date information on corporate project management platforms. Reporting the status of products to management with the aid of reports, presentations, Gaant charts, and other project management tools.
• Keeping informed of new regulatory developments and educating other team members on new changes to FDA rules, regulations, and laws. Developing effective regulatory strategies based on the most current guidance and information.
• Authoring, review and/or approval of Standard Operating Procedures.
• Management of a team of at least one direct report.
• Keeping informed of new regulatory developments and educating other team members on new changes to FDA rules, regulations, and laws. Developing effective regulatory strategies based on the most current guidance and information.
• Authoring, review and/or approval of Standard Operating Procedures.
• Contributing to a productive working relationship with all business partners sites and cross functional areas
• Positive, creative solution mind set for addressing complex products and situations.

Skills and Requirements:

• Innovation, entrepreneurial attitude, customer orientation, team leadership, adaptability/flexibility, results-oriented, control of budgets/costs, Self-development.
• Education: A minimum of a B.S. degree in chemistry, biology, pharmacy, or a similar field. A graduate degree in one of these fields, or in regulatory affairs, is preferred. Languages: English required; Spanish preferred
• Experience (years/area): 8-10 year's experience in the pharmaceutical industry with at least 5 years' experience in regulatory affairs and at least 7 years of respiratory products.
• Management experience preferred.
• Specific knowledge and experience with injectable products are required, for example: sterility and aseptic practices; media fill and filter validation; facility qualification.
• A technical background which includes analytical and micro testing work is preferred. The job also requires Substantial understanding of current pharmaceutical development and CMC regulatory affairs practices including regulatory guidelines, federal regulations, and legal considerations. The candidate should have experience with development of complex drug products and submissions to FDA, particularly in various injectable products.
• Should have familiarity with common regulatory software: eCTD compilation, SPL creation, document proofing, enterprise resource management, project management platforms, word processing, and document processing.
• They seek a candidate with excellent persuasive communication skills (written and verbal) who possesses strong critical thinking skills and the ability to logically analyze and resolve problems.
• Demonstrate understanding and experience working with third parties in various business relationships. For example, working with contract manufacturers, analytical testing facilities, clinical organizations, state licensing agencies, and third-party labellers/printers. Other examples are in- and out licensing arrangements, where they sell another company's product (and potentially does the RA work) or where another company sells their product.
• Travel may be required, including international travel.
• General management skills, good written communication skills, strong interpersonal and people development skills, strong results-orientation, superior leadership skills, ability to anticipate problems and solve them successfully.
• The candidate must be able to prioritize, multi-task and work in a very fast paced and dynamic environment and must be able to meet aggressive deadlines.
• Must be highly organized, self-motivated, detail-oriented, and must possess the ability to work independently without oversight while also engaging as an enthusiastic team player and leader in group working activities.
• The ideal candidate will use creativity and resourcefulness to find the best solution to novel situations and will assist with the continuous improvement of their internal systems and procedures.
• This job operates in professional environment. This role routinely uses standard office equipment such as computers, phones, printers, etc.
• This is a full-time salaried position.
• Standard days and hours of work are Monday through Friday, 9:00 a.m. to 5 p.m.
• The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
• Is required to interact with internal and external contacts independently.
• Is regularly required to talk or hear either in person or over a dial tone phone, as well as a mobile phone, when applicable.
• Is often required to stand, walk, bend, lift, or sit.
• Is required to occasionally lift office products and supplies, up to 40 lbs.
• Is desk-based and may be sitting for long periods of time.
• Must regularly use fingers and hands for fine manipulation: typing, writing, using hand-held device (iPad, laptop, cell phone, keyboard, printer)
• Must communicate clearly: phone calls, emails, in-person conversations.
• Must possess ability to make sound decisions, process complex information, manage multiple tasks simultaneously, model behavior for other employees, and other cognitive functions.

If you are having difficulty in applying or if you have any questions, please contact Ishmam Quddus at (+1) 718-577-5021 or i.quddus@proclinical.com.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology, and medical device companies.

Proclinical Staffing is an equal opportunity employer.

#LI-IQ1