Medical Device Regulatory CMC Strategist (Manager)
September 17, 2016

About the company
A career at the company offers opportunity, ownership and impact.

All over the world, the company colleagues work together to positively impact health for everyone, everywhere. Our colleagues have the opportunity to grow and develop a career that offers both individual and company success; be part of an ownership culture that values diversity and where all colleagues are energized and engaged; and the ability to impact the health and lives of millions of people. the company, a global leader in the biopharmaceutical industry, is continuously seeking top talent who are inspired by our purpose to innovate to bring therapies to patients that significantly improve their lives.

Role Description
Responsible for the development of regulatory strategies, submissions and compliance activities for medical device-related development programs and commercial products supporting the company Consumer Health Business Unit.

Provide and drive strategic and operational global regulatory CMC direction and documentation for assigned projects/products covering initial registrations and approval/post approval activities. Lead the preparation of medical device information for submission to global regulatory agencies, generate and drive device-related strategies, assess risks and develop contingency/mitigation plans. Serve as the regulatory lead and contribute to due diligence teams exploring new business opportunities.

Act as the global medical device regulatory CMC representative within cross-functional project teams, involving the interpretation of regulations and guidelines and the assessment of global implications for strategic decisions.

Accountable for assigned medical device programs, managing daily delivery of regulatory and strategic activities, including post-approval changes, portfolio growth initiatives, and ongoing compliance of commercial products in the portfolio.

May represent CMC during interactions with regulatory agencies and external partners.

Operate independently to resolve issues and manage regulatory risks and ambiguous situations within project teams. Investigate opportunities for regulatory innovation / promote the use of novel approaches within project teams to resolve issues and problems.

Contribute to the development of internal policies, processes and procedures supporting the progression and maintenance of the company Consumer Health portfolio as appropriate.

Serve as the primary medical device regulatory strategist for projects within the company Consumer Health portfolio, providing regulatory assessments and developing regulatory strategies independently.

Act as the global medical device regulatory CMC representative within cross-functional project teams.
Interpret regulatory requirements for consumer medical device products, develop strategies (including novel approaches), assess risks and develop contingency proposals. Use technical and scientific knowledge to conduct the appropriate analysis of submission documentation. Look for ways to improve and promote quality and demonstrates accuracy and thoroughness.

Author device-related regulatory documentation, coordination and management of global submissions, including the assessment and management of commercial license status, maintenance of product compliance and management of change control.

Collaborate effectively across a network of other stakeholders, partners and customers, to deliver high quality submissions for the company Consumer Health portfolio. Develop resolution proposals for regulatory CMC/information management issues with project/program stakeholders. Display a willingness to make timely decisions, exhibit sound and accurate judgment.

BS or equivalent scientific/engineering/pharmaceutical development sciences degree. Must have a minimum of 3 years medical device regulatory experience.

Ability to interpret and apply global / regional CMC regulatory policies and requirements for assigned portfolio.

Candidate is required to have a sound understanding and advanced functional knowledge of the medical device industry with a clear understanding of development/commercial manufacturing, including technical writing skills. Competent working knowledge of computer based systems such as Microsoft Office, controlled documentation systems. Able to learn and navigate tracking/change control systems, compliant and consistent use of systems (including GMP validated systems) and willing to train and support others in system use.

The candidate is required to have a clear track record of effective teamwork, collaboration, and communication, and also demonstrated leadership ability in a cross-functional matrix team environment. Product management along with planning/organizing by prioritizing and planning work activities and change agility are also essential attributes.

Normal office based and needs to be able to travel on public transport, including international.

Travel to external (trade association or agency) or internal meetings as required.

Other Information - Internal
Colleagues who are issued an Incident Final Warning (IFW) on or after January 1, 2016, are not eligible to post and compete for a position for a period of 12-months from the date an IFW is issued.

EEO & Employment Eligibility
the company is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. the company also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. the company is an E-Verify employer.
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