Manager Regulatory Affairs

POSITION: Regulatory Affairs Manager

Primary Function/Primary Goals/Objectives :

Provide support for the regulatory department to ensure efficient and compliant business processes and environment. Execute regulatory tasks and play a consultative role by partnering across business functions. Assist in identifying data needed, obtaining these data and ensuring that they are effectively presented for the registration of products and/or conducting regulatory assessments using worldwide data. Prepare and submit documentation or oversee preparation of documentation needed for registration in India or in ex India markets.. Provide technical leadership to business units.

Major Responsibilities:

Responsible for compliance with applicable Corporate and Divisional Policies and procedures and Regulatory SOPs. Assist in Regulatory SOP development and/or review. Provide regulatory input to product lifecycle planning. Assist in the development of regulatory strategy and update strategy based upon regulatory changes. Interpret and apply regulatory requirements. Understand, investigate, and evaluate regulatory history/background of product class, Claims context in order to assess regulatory implications for approval. Understand the business environment and relate extensive knowledge of internal and external activities to trends; Assist in determining trade issues to anticipate regulatory obstacles. Participate in risk-benefit analysis for regulatory compliance. Plan and organize project assignments of substantial variety and complexity; initiate and/or maintain schedule for projects and project milestones. Depending on specific role, the Regulatory Affairs Manager may be involved in various regulatory activities (review of clinical documentation; regulatory submissions and follow-up; evaluation of product and manufacturing changes for regulatory implications; maintaining annual licenses, registrations, listings and patent information; review and approval of label changes, advertising and promotional items; provide regulatory input to product safety issues and product recalls, etc.)

Responsibilities (Influence/Impact/Leadership):

May provide direction and guidance to exempt and/or skilled non-exempt levels of employees; act as a guide to less-experienced staff. Participate in the development of others by facilitating training and providing feedback and guidance. Interface with a variety of management levels on significant matters, often requiring the coordination of activity across organizational units. Perform work without appreciable direction.

Education:

Background/Skills/Knowledge:

8-10 years of experience in regulatory preferred, but may consider quality assurance, research and development, scientific affairs, operations, or related area. 3-4 years of experience in a regulated industry (e.g., nutritionals, medical/pharmaceutical products).

Regulatory knowledge of (as applicable):

Regulatory requirements, guidelines, policies, standards, practices, history, ethics, agency structure and processes, etc.

GxPs (GMPs, GLPs, GCPs).

Principles and requirements of promotion, advertising and labeling.

Food/ Pharmaceutical regulations, especially in India/ Asia is an added advantage.

Communication skills and ability to:

Communicate effectively verbally and in writing.

Communicate with diverse audiences and personnel.

Work with and negotiate with people from various disciplines, organizations, and cultures.

Follow scientific arguments, identify regulatory scientific data needs and, with supervision, solve regulatory issues and define regulatory strategy.

Evaluate various technical alternatives.

Other skills:

Strong attention to detail.

Create and manage multiple project plans and timelines.

Think analytically; organize and track complex information.

Proficient computer skills.

Accountability/Scope:

Execute and manage technical and scientific regulatory activities. Function independently as a decision-maker on regulatory issues and assure that deadlines are met. Effectively communicate, prepare, and negotiate internally and externally with various regulatory agencies. Lead a cross-functional project team.