Title:  Sr.Mgr,Regulatory Affairs Strategy

The Senior Manager Global Regulatory Affairs (GRA), Specialty Business, partners with leaders across the organization to be the ‘face of the asset’ from a regulatory perspective.  The role will be responsible for formulating, developing, and executing a comprehensive regulatory strategy integrating US and ex-US regulatory requirements and health authority engagements to drive product development, global registration, and ultimately desired labeling for one or more assets within or across therapeutic areas. The position would also act as a US agent. This position if located in Princeton, New Jersey and employs a HYBRID work schedule: 3 days in office; 2 days remote.

Responsibilities

• Provide strategic, tactical, and operational direction and guidance to product teams for assigned inline and/or pipeline assets in one or more therapeutic areas
• Develop, socialize, execute, and maintain the regulatory commitments and requirements for assigned assets
• Retain contemporary knowledge of regulations, directives, guidelines and policies that may have an impact on product development to assess approval pathways and associated risks
• Identify and communicate issues to management related to product development that could impact effective regulatory execution
• Set and monitor submission timelines along with other key stakeholders
• In association with other regulatory leaders, facilitate and lead communications with health and/or competent authorities, where applicable
• Ensure  is in accordance with established procedure within the department
• Must be involved in writing or to facilitate the authoring of certain sections of product submissions dossiers
• Develops and manages relationships with external regulatory agencies, industry groups and business partners 
• As applicable, shall review the audit reports, Regulatory Agency inspection reports and responses to the inspection observations if any, when received
• Compiles, prepares, and reviews regulatory submissions to regulatory agencies as applicable; may be the US agent for selected assets
• Conduct department level training, as necessary, to educate regulatory strategists and other roles in the department on regulatory requirements, policies, and procedures
• Participate in authoring and/or reviewing of the departmental procedure as applicable

Qualifications

• Advanced degree preferred (PhD, MD, PharmD, MBA, JD)
• Minimum of 10+ years (3-5 years for Senior Manager) of experience within global regulatory affairs in the pharmaceutical (ideally) or biotech industries
• A thorough understanding of drug development process and regulatory requirements for product development across modalities and disease areas
• Direct experience authoring and filing clinical trial or marketing applications across major regulated markets and a knowledge of the developing biologics regulations

This position is part of the Annual Performance Bonus Plan. Employees are eligible to participate in Company employee benefit programs which include medical, dental and vision coverage; life insurance; disability insurance; 401(k) savings plan; flexible spending accounts; and the employee assistance program. Employees also receive various paid time off benefits, including vacation time and sick time.

The compensation and benefits described above are subject to the terms and conditions of any governing plans, policies, practices, agreements, or other materials or documents as in effect from time to time, including but not limited to terms and conditions regarding eligibility. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company, or individual department/team performance, and market factors.

The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees as assigned to this job. Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of the incumbent(s).

We provide equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, military or veteran status, generic predisposing characteristics or any other basis prohibited by law.

Notice to Agency and Search Firm Representatives:

Sun Pharmaceuticals (Sun) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Sun employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Sun. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral.