Associate Director of Regulatory Affairs - (US-NJ-Camden - 08110)

Minimum Education: Bachelors
Job Type: Full Time
Jobcode: 2853
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Our client is a publicly traded pharmaceutical company headquartered in NJ with over 10 years of success in the development and commercialization of OTC therapeutics. The company has some of the strongest financial indicators in the industry, an experienced management team and a robust pipeline. They also offer an empowering corporate culture that is focused on the professional development and advancement of clinical team members.

Job Responsibilities:
1) Assist with promotional global regulatory services and also assist business development in the promotion of such activities
2) Work with company sites and suppliers/partners to ensure that project activities are progressing as per development plans and appropriate regulatory standards
3) Organize training (as necessary) to ensure that projects comply with development plans and regulatory standards
4) Organize and attend advice meetings and pre-filing meetings to include preparation, submission and follow-up of scientific advice
5) Liaise with regulatory agencies
6) Prepare for and coordinate clinical trial applications (INDs and CTAs) when located in the countries in which RA is responsible for this task
7) Assist in the evaluation of potential API suppliers
8) Prepare submissions for regulatory agencies in accordance with current legislation and PVG requirements
9) Prepare marketing authorization applications (ANDA, NDA, and CTD) and responses to objections/questions issued by regulatory authorities
10) Prepare amendments/variations, renewals and annual reports
11) Plan resources and prioritize activities to meet multiple project timelines, financial milestones and personal objectives
12) Assist with registration compliance programs for external clients where regulatory responsibility is designated to company
13) Maintain a high level of current regulatory knowledge through personal development and training
14) Assist development and training of any junior RA staff
15) Ensure that all training delivered is correctly documented
16) Share information of new regulations/laws/publications with other RA staff and/or company departments (as necessary)
17) Use appropriate information systems to report project progress and performance
18) Provide mechanism for continuous improvement monitoring
19) Write clear and concise dossiers, accurate reports and memos to a high technical standard
20) Make effective presentations at all organizational levels

Job Requirements:
1) Bachelor of Science (MS preferred) in Regulatory Affairs, Pharmacy, Chemistry or Biology
2) Minimum 5 years of experience in US regulatory affairs (new product approval and/or generic OTC drugs)
3) Experience in the development of both innovative and generic products a plus
4) Experience in international regulatory affairs preferred
5) Expertise in CTD and US procedures, including BLA, NDA, 505 (B)(applications, ANDA, Paragraph IV certification, suitability petitions and INDs
6) Knowledge of multiple dosage forms
7) Ability to manage multiple, complex regulatory projects
8) Proficiency in computers (publishing tools, databases, word processing, project and spreadsheets)
9) Experience in supervising and/or mentoring junior staff
10) Detail-oriented with ability to accomplish objectives
11) Clear thinking/logical with strong personal organizational skills
12) Ability to work within a diverse, cross-functional team in a matrix organizational environment
13) Self-motivated and autonomous
14) Excellent communication skills (written and verbal)
15) Ability to work within a fast-moving and demanding product development environment
16) Willing to travel (domestic and international)

Applicants are encouraged to apply directly by going to:http://www.sterlinglifesciences.com/jobs/lifesciences-jobs-02853.html

Salary: $115k-$125k