Senior Associate - Regulatory Affairs: The Grapevine Group

REGULATORY AFFAIRS SENIOR ASSOCIATE

JOB DESCRIPTION

Summary Description: Responsible for coordinating sections of drug applications, assessing change control documentation, coordinating dosage form development for line extensions, writing SOPs and functioning as liaison with FDA/Health Authorities and contract manufacturing partners. Actively participate in project teams. Strength in the NDA/IND sector and electronic submissions are critical to the situation. Clinical exposure is helpful.

Principle Duties / Responsibilities:

§ Determine regulatory strategy, plan and coordinate documentation/data for submission to ANDAs, INDs and NDAs as needed (Original applications, amendments, supplements, and annual reports) in CTD format. Experience with electronic submission required.

§ Collaborate with cross-functional team members across departments and other functional areas as the regulatory plan is developed, reviewed and periodically refined.

§ Educate cross-functional teams regarding regulatory risks and implications for the strategies. Encourage team planning for key regulatory events.

§ Coordinate activities within company and external contractors, as needed.

§ Ensure all documentation and regulatory submissions are prepared to meet regulatory standards. Ensure consistency/completeness/adherence to standards for all regulatory submissions.

§ Produce approvable components of regulatory dossiers with appropriate flexibility. Function as FDA liaison for assigned applications. Assume responsibility for comprehensive and appropriate communication (both written and verbal) with regulatory authorities

§ Assess change control documents for FDA reporting requirements.

§ Create and revise SOPs governing regulatory activities.

§ Participate in corporate evaluation of potential licensing and divestment projects and provide regulatory support.

§ Actively participate in internal and external seminars, conferences and symposia to build knowledge in regulatory and technical areas. Build technical knowledge and experience to enhance personal regulatory contributions to project teams, colleagues and others.

§ Design and implement databases as needed.

Requirements: BS Degree in Pharmacy, Chemistry or related science (biochemistry, biology, pharmacy, microbiology) with a minimum of 6 years plus professional experience (at least 5 in pharmaceuticals) in manufacturing, laboratory, development, quality control/assurance or regulatory affairs (preferred). At least 4 years direct experience regulatory experience required. Medical Device experience a plus. Dietary supplement experience a plus. Strong organizational and interpersonal skills required with excellent written and verbal skills. Proficient in Microsoft Office Suite software (Word, Excel, PowerPoint, Access or other database experience a plus). Local candidates strongly preferred.

Compensation: 70-80k + 15% bonus + stock options