Regulatory affairs director job description

The Director, Government and Regulatory Affairs will be responsible for regulatory, compliance, and legislative matters, grant applications and grant administration, and reporting to multiple municipal and state agencies in California. This position involves: superior communication skills including extensive written and verbal advocacy; grant application work to include project managing, preparing and submitting grant applications; data analysis to ensure accurate reporting, and analysis regarding regulations, legislation, drafting legislative and regulatory proposals and establishing processes and procedures to ensure compliance with state regulations and multiple reporting requirements. The position will also involve proactive outreach to elected and non-elected municipal and state officials. The Director, Government and Regulatory Affairs will also coordinate with various internal departments to monitor, prepare, and report on California compliance obligations-including restructuring related compliance obligations-to the California Public Utilities Commission (CPUC), other relevant parties and state regulatory agencies and will function as the point of contact with the CPUC's designated compliance monitor.
Job Requirements/Special Skills

Develop and maintain an on-going, positive relationship with legislators, regulators and other government officials.
Favorably represent Frontier and effectively advocate its positions with key stakeholders and others in the industry.
Monitor and interpret regulatory orders and legislation to identify compliance requirements, business opportunities, and threats.
Communicate legislative and regulatory opportunities and threats internally to impacted management and impacted groups within the organization, coordinate development of a necessary advocacy strategy, and execute advocacy strategy effectively to take advantage of opportunities and mitigate threats.
Develop and oversee procedures designed to maintain an on-going awareness of and compliance with all state rules, laws, and agency orders applicable to telecommunications carriers and effectively guide Frontier through legal and regulatory obstacles to its business, product and financial goals.
Provide guidance to Frontier leadership on issues involving state regulatory and government matters.
Help craft necessary compliance protocols, documentation, and processes in collaboration with other business units and external parties, as necessary.
Coordinate data identification and collection to ensure timely response to internal and external data requests on topics such as service quality, fiber to the premise buildout and status on required engineering projects.
Produce compliance reports that are accurate, consistent, verifiable, and understandable and serve as primary point of contact for the California CPUC compliance monitor.
Ensure the confidentiality and integrity of data and provide analysis and trends surrounding data and reports.
Support other Frontier personnel on understanding compliance requirements/data analysis/reporting.
Identify creative means to access data and develop narratives based on the data to facilitate understanding.
Own additional ad hoc regulatory and compliance data reporting and analysis projects.

Qualifications:

Bachelor of Science in Business, Finance, Economics or related field,
Graduate degree preferred,
Minimum of 5 years of relevant experience, experience in wireline telecommunications experience regulatory affairs (California Public Utilities Commission experience or experience with another agency that interacts with the CPUC) and/or government relations strongly preferred,
Ability to work independently and successfully address multiple priorities,
Proficiency in MS Word, PowerPoint and Excel,
Strong analytical, problem-solving, and written and verbal communication and presentation skills.
Proven ability to effectively distill and relay complex data issues in a straightforward manner
Ability to work well with cross-functional teams including ability to build a positive rapport with others working remotely, ability to understand complex legal and regulatory documents, and
Ability to develop positive relationships within the industry and with Frontier's business partners.

Experience

• At least 10 years experience in the pharmaceutical industry with 7 years preferably in Regulatory Affairs or in Drug Development.

• Demonstrated skills and competency in project management tasks

• Working knowledge of ICH Guidelines and GCP including international regulatory requirements for the conduct of clinical development programs.

• Broad knowledge of drug development process and client needs.

• Comprehensive understanding of processes associated with Global Regulatory Affairs activities

• Skilled in trouble-shooting and issue resolution

• Strong interpretation and analytical skills within and across projects / portfolios leading to documented efficiency improvements

• Ability to lead diverse cross-functional teams and deliver measurable results

• Experience in managing a project budget with documented cost containment strategies.

• Ability to work with minimal supervision.

• Excellent communication, facilitation and presentation skills

• Good conflict management skills

• Good computer skills with a working knowledge of a range of computer applications.

• Excellent planning, time management and organization skills.

• Ability to work efficiently and effectively in a matrix environment.

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**Date:** Sep 25, 2022

**Location:** Ann Arbor, MI, US, 48103

**Company:** Terumo

At Terumo Cardiovascular, we develop, manufacture and distribute medical devices for cardiac and vascular surgery with an emphasis on cardiopulmonary bypass, intra-operative monitoring and vascular grafting. This includes a full-line of perfusion products, endoscopic vessel harvesting products and surgical stabilization products.

Our mission is to work as a team to save one more life, today and every day. We do this by providing lifesaving technology to cardiac surgery teams around the world.

**Job Summary**

This position is responsible for managing resource allocations for product development, sustaining production, and quality improvement projects. Maintains current knowledge of global medical device regulations, acts as consultant to other departments, participates in decision-making concerning policies, regulatory requirements and strategies, and manages external consultants as needed. Defines information and actions needed to meet requirements, prepares documents and/or submissions required to obtain clearance or approval from governmental agencies for global commercial distribution of products. Guides and supports acquisition and partnership development projects with attention to due diligence and subsequent regulatory compliance. Maintains compliance standing with regulatory and certifying agencies.

**Job Details/Responsibilities**

1. In all actions, demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.

2. Provide expertise to global regulatory strategy development and implementation to achieve completed regulatory submissions in a timely and fiscally responsible manner.

3. Establish and execute submission schedule(s) and achieve plan commitments. Assure tactical objectives are achieved in U.S. and non-U.S. submissions, label and advertising review, removals and corrections support as well as recommend and implement procedural improvements.

4. Assure compliance requirements are achieved. Interface with U.S. and non-U.S. government officials on compliance issues that assures credibility bringing issues to successful resolution.

5. Manage timely regulatory clearances for new products; maintain existing marketing authorizations.

6. Prepare U.S. and non-U.S. submissions including but not limited to IDE, 510(k), technical files, establishment registration and device listing.

7. Utilizes the systems and processes in place to attract, develop, engage, train and retain talented Associates; creating a work environment where Associates can realize their full potential, thus allowing the organization to meet business needs.

8. Perform other duties as assigned.

**Qualifications/ Background Experiences**

Requires a four-year college degree and a minimum of ten years of experience in Regulatory Affairs and/or Quality for medical devices or pharmaceuticals, including one or more of the following: clinical studies, global marketing applications, or quality systems management. Of the ten years of experience a minimum of seven years must include supervisory experience. Basic computer software skills, i.e., Microsoft Office. Advanced degree or additional professional training preferred.

_Terumo Cardiovascular is an equal opportunity employer. We promote recognition and respect for individual and cultural differences, and we work to make our employees feel valued and appreciated, whatever their race, gender, sex, sexual orientation, gender identity and/or expression, and genetic information._

**EOE Minorities/Women/Disabled/Veterans**

**Nearest Major Market:** Ann Arbor

**Nearest Secondary Market:** Detroit