Regulatory Affairs Manager CONTRACTOR 1 YEAR

The Regulatory Affairs Manager will lead, manage, and provide strategic direction and oversight to the Head of Regulatory Affairs and above regulatory teams to develop and execute regulatory strategies and plans for the country.

Job Responsibilities:

1. Manage the assigned portfolio in the development of regulatory strategies to support the registration of clinical trial applications, new products, line extensions, major variations, and lifecycle management. Provide strategic regulatory input into global regulatory strategies, thus providing optimal support for meeting local business objectives under Country Regulatory Head lead.
2. Develop strong partnerships with in-country (e.g., BU leads, Market Access, Marketing, Supply Chain) and with above country (e.g., Country Strategists, GCMC Hub, Submission and labeling/artwork Hubs, Therapeutic Area and Regional Teams) to facilitate the development and implementation of registration strategies to expedite the registration of new products, line extensions, and life-cycle optimization.
3. Responsible for their own personal development, leadership, and performance to achieve company objectives and agree training and development needs with Country Regulatory Heads to develop and enhance individual capabilities and capacities.
4. Responsible for developing and enhancing relationships with key external agencies (HA’s/BoH, Regulatory KOL’s, etc.). Manage the HA/BoH interface throughout the development and lifecycle of a product.
5. Maintain licenses (e.g., Marketing Authorizations) in compliance with local regulations by ensuring that corporate regulatory processes, SOP’s, and systems are followed ensuring training in P2L are completed 100% (systems and procedures).
6. Maintain compliance at 100% in all regulatory systems. Where needed, oversee and manage the completion of CTA, NDA, and Lifecycle (LC) submissions and approvals as per established EM performance metrics.

Skills:

1. Understanding of regulatory agency philosophies, culture, and developing trends in the regulatory environment. Experience in preparing and submitting CTA’s, NDA’s, variations, and LC submissions. Working with and influencing opinion leaders, external organizations, and CRL’s facilitating approval of submissions. Is driven to continually enhance regulatory expertise, both locally and globally.
2. Knowledge of drug development practice, rules, regulations, and guidelines.
3. Familiarity with factors likely to influence the regulatory environment, including new and emerging guidelines relevant to Regional regulatory strategies and implementation plans. Maintains internal and external networks to learn in advance about new regulatory trends or changes impacting the Regulatory, Medical, and overall Business strategy.
4. Strategic Thinker: Provides strategic contribution and anticipates what RA needs to contribute to develop and achieve business objectives. Effectively explores alternative regulatory strategies and positions to reach outcomes that gain the support and acceptance of all parties.
5. Communication skills: Clearly conveys information and ideas through a variety of media to individuals or groups in a manner that engages the audience and helps them understand the message.
6. Negotiation skills: Can negotiate skillfully in tough situations with both internal and external groups. Can be direct and forceful as well as diplomatic. Gains trust quickly of other parties to the negotiations. Has built a strong relationship with the local health agency and other relevant stakeholders (regulatory KOL’s) and pro-actively manages issues with the HA’s and other key external stakeholders.
7. Problem Solving: Effectively identifies issues and challenges and works with partner groups to identify options and implement agreed upon solutions.
8. Detailed Oriented: Can be thorough and complete with high quality.
9. Project Management: Can manage complex and multiple projects.