Regulatory Affairs Specialist

At Bayer we're visionaries, driven to solve the world's toughest challenges and striving for a world where ,Health for all, Hunger for none' is no longer a dream, but a real possibility. We're doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our capabilities and redefining 'impossible'. There are so many reasons to join us. If you're hungry to build a varied and meaningful career in a community of brilliant and diverse minds to make a real difference, there's only one choice.

Regulatory Affairs Specialist 

POSITION PURPOSE:

• Responsible and accountable for all regulatory affairs activities of Bayer Pharma (PH) within assigned portfolio and/or geography. In alignment with Head of RA PH-South Asia, provide effective functional leadership and governance into planning, developing and executing regulatory strategies within assigned scope, alignment of these with business goals and plans through cross-functional collaboration enabling efficient implementation of growth, brand value

• Scope of regulatory activities includes all licensing related activities (including timely planning and execution of maintenance, change management) for imported products, local products and export markets dealing with the relevant Health Authorities and government bodies in relation to pharmaceuticals (Rx) & medical devices for assigned portfolio and/or geography

• The position will have to consider and balance the business objectives and priorities within assigned portfolio, analyze necessary resource and time allocation, discuss and propose this for alignment with Head of RA PH-South Asia accordingly. The position holder may supervise junior RA staff in managing the Lifecycle Management activities of pharmaceutical portfolio (eg. Renewals, CMCs) when required

• Ensure the best regulatory planning and preparation for all new chemical/biological entities (NCE/NBEs), new indications and line extensions to be registered in the best possible time frame and with the best possible label. Maintains full awareness of all regulatory activities for assigned portfolio and ensures deadlines and performance standards (incl. compliance KPls) are established and met

• Ensure that the assigned portfolio products remain compliant with all relevant regulatory, corporate and legal policies, procedure, practices and local regulations throughout the entire product life cycle. Develop and propose to RA India team standards to monitor and track processes for compliance and governance as best practice sharing for team adoption

• Work closely with relevant local, regional and global stakeholders, cross-functionally and within regulatory affairs, to deliver optimal company outcomes

• Be actively engaged to inspire, motivate, support team members towards functional excellence to meet current and future RA India objectives for assigned portfolio and be seen as value-add business partner

• Ensure maintenance of required licenses for proper functioning of the company, e.g. GMP certificate, manufacturing license (if applicable), special functioning licenses, and provision thereof on request

• To ensure local regulatory processes and procedures reflect current best practice and local regulations
YOUR TASKS AND RESPONSIBILITIES:

• Responsible and accountable for planning, developing and execution of regulatory submissions and approvals in the country for the assigned PH portfolioenabling the achievement of business strategic objectives as well as for ensuring regulatory compliance. Priority setting and flexibility are constantly needed.

• Conduct regulatory probability assessment of approval and HA review milestones to allow optimal business planning

• Operating in a highly regulated environment that is constantly changing, the incumbent provides input and insights for regulatory probability assessments,
anticipating these changes when making probability assessments based on experience and knowledge of the environment

• Within assigned portfolio or projects, build relationships with the Health Authorities and other government bodies, as key customers essential for
achieving business goals. The relationship is based on trust, transparency and partnership

• Maintain compliance with all relevant regulatory requirements with no supply disruption due to lack of regulatory oversight or suboptimal planning

• Supports Head of RA PH-South Asia in development, implementation of processes, SOPs, and systems

• Secure and maintain compliant product licenses, product labelling and participate in promotional material review/approval for products in assigned
portfolio
WHO YOU ARE:

• Post-graduate in Life Sciences (preferably Pharmacy) with minimum of 3 years pharmaceutical industry experience in regulatory affairs with proven track record and experience in health authority interactions and negotiations, end-to-end regulatory submissions and approvals across various therapeutic areas and categories. Demonstrated track record of providing workable solutions to complex regulatory topics.

• In depth understanding of CMC and clinical aspects for regulatory submissions and other licensing requirements in India. Experience with locally manufactured products and export to neighboring countries (eg. Nepal, Bangladesh, Sri Lanka) highly desired

• The successful candidate will have the requisite experience to act as an effective business partner to country commercial organization. Be self-starter with excellent interpersonal and communication skills to facilitate the ability to negotiate and influence others, while dealing with issues which have considerable scientific and regulatory uncertainty

• Have analytical ability to assess complex/ambiguous situations and proactively identify potential issues and future trends and their impact on assigned portfolio. Propose solutions, risk mitigation strategies

• Fluent in English. Excellent communication skills to communicate effectively both orally and in writing to represent Bayer at external meetings and RA India at internal cross-functional and regional/global meetings

• Ability to multi-task without compromising on quality of outcome, compliance. Good project management skills to organize, prioritize and direct diverse activities in a changing environment often under time pressure

• Solid and demonstrated knowledge of all compliance aspects related to the regulatory affairs function, including detailed understanding of the process and policies of the national or agency or extensive experience with a related national health authority

• Global understanding of Regulatory Affairs and India contributes within this. Good working knowledge of regulatory framework in EU, US and International Standards (e.g. ICH, GCP, GMP) highly desired.

Bayer is an equal opportunity employer that strongly values fairness and respect at work. We welcome applications from all individuals, regardless of race, religion, gender, age, physical characteristics, disability, sexual orientation etc. We are committed to treating all applicants fairly and avoiding discrimination.