Compliance Manager - Pharma/Manufacturing Firm - LLB

Compliance Manager

Role and Responsibilities:

- Devise and implement various compliance programs required to maintain and improve compliance behaviours through effective implementation of policies, processes, training and support;

- Develop, maintain, monitor and communicate a clear Compliance plan to senior leaders, managers & employees. Identify and focus effort on prioritized compliance risk areas across the Business;

- Support the compliance risk management efforts including gap assessments and corrective action plans;

- Driving quarterly Compliance Council Meetings as per the defined Charter, owning the action items and collaborate with business to ensure effective closure;

- Managing the statutory compliances for different business units of the company through digital tool;

- Addressing day to day compliance queries of employees directly or in collaboration with the relevant stakeholders;

- Manage compliance assurance process as per defined norms;

- Keep updated on knowledge of applicable regulatory requirements and best practices in Pharma;

- Drive risk assessments based on local applicable regulatory requirements and global Compliance initiatives;

- Conduct training sessions and execute communication campaigns;

- Collaborate with other departments and direct compliance issues to appropriate existing channels for investigation and resolution.

- Participate in internal investigations based on internal reporting of a compliance concern.

Required Skills :

The candidate should be a mature/independent/experienced lawyer with compliance background having below qualities :

- Knowledge and understanding of Business Operations and Strategy, good financial acumen, understanding of pharmaceutical industry and practices.

- Good understanding of regulatory landscape and handling statutory compliance for manufacturing & commercial units

- Knowledge of industry specific laws and ability to apply & contextualize legal knowledge to business problems

- Strong/Substantive experience in compliance practice areas including but not limited to Ethics, Anti-Bribery Anti- Corruption, Trade Compliance, Conflicts of Interest, Gifts & Hospitality and business compliance in relation to manufacturing setup.

- Ability to identify, assess and mitigate business, legal and compliance risks.

- Ability to conduct appropriate desk based and field monitoring of business activities.

- Ability to work with the business to explain observations, create appropriate corrective & preventive action plan (CAPA) and ensure closure of the CAPA by the business

- Ability to draft Compliance Policies & Procedures and effectively implement & monitor the same for assigned Business Units

- Ability to provide clear, pertinent, and timely advice to business

- Develop and sustain working relationships with stakeholders

- Ability to conduct training sessions and execute communication campaigns

- Design and drive Third-Party Risk Management process for the assigned Business Units

- Team player with a proven ability to integrate and adapt to a new environment

- Deal with ambiguity and complexity

- Pragmatic, hands-on, problem solving attitude and a high sense of priorities and urgency

- Proven experience in effective stakeholder engagement

- Excellent written and spoken English. Proficiency in Telugu/Gujarati/ Hindi is desirable

Mandatory Skills:

- Well versed with Legal and Compliance requirements in a manufacturing setup.

- Expert knowledge and experience with Ethics and Compliance programs and processes.

- Deeper understanding of various regulations including pharma/ medical devices regulation and consequence of non-compliance.

- Ability to identify, evaluate and manage compliance risk.

Years of Experience : 6 to 10 Years

Education/Qualification : LLB